integrated solution enhances point-of-care testing networks c

Vol. 32 No.3 • 5 /2015ISSN 1068-1760

WORLD’S CLINICAL LABORATORY NEWS LEADERDAILY CLINICAL LAB NEWS

V I S I T

Diabetes Biomarker KitBridges the Glycation Gap

AAnewly-released diabetes biomarkerassay is designed to close the infor-

mation gap between daily blood glu-cose testing and the two-three monthHbA1c (glycated hemoglobin) reading.The new Glycated Serum Protein (GSP)LiquiColor assay, which has both [US]Food and Drugs Administration and

Cont’d on page 10

Noninvasive DiagnosticTest for Colorectal Cancer

RResearchers have developed a ge-netic test for colorectal cancer

(CRC) using a novel liquid “biopsy” ofcirculating tumor cells (CTCs) fromwhole blood, a rapid, easy-to-use tech-nology developed to improve treat-ment, monitoring, and overall care ofcancer patients.

Cont’d on page 13

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UUnnecessary blood transfusionsmay increase healthcare costs

both directly, because blood is an in-creasingly scarce and expensive re-source, and indirectly due to thecomplications associated with trans-fusion.

Cardiac surgery patients who re-ceive blood transfusions are be-

lieved to have more complicationssuch as infections, heart attacks andstrokes, and this has led to specula-tion that avoidance of transfusionwill improve clinical outcomes.

A team of scientists led by those atthe University of Bristol (UK; www.bris.ac.uk) and those at Nuffield Department of Population Health

Transfusion Protocols Compared After Cardiac Surgery

PCR Assay for Myotonic Dystrophy Gene Targets

II n a proof-of-principle study, sci-entists have developed a con-

ventional-PCR diagnostic test thatspecifically identifies myotonicdystrophy type 1 (DM1) gene tar-gets from whole blood samples in15 minutes, obviating the need forprior DNA purification or concen-tration.

Ultrasensitive Test For Peanut Allergies

CCurrent peanut allergy tests arenot very reliable when it comes

to diagnosing the severity of an indi-vidual’s allergic reaction, which canrange from hives to life-threateninganaphylactic shock. Severity ofpeanut allergies is linked to allergen-specific immunoglobulin E (IgE) an-tibodies in blood, but diagnostics

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Integrated Solution EnhancesPoint-of-Care Testing Networks

See article on page 4

C hallenges faced byclinical laboratory

point-of-care coordina-tors can now be moreefficiently tackled aspart of an innovative in-formatics solution formanaging in vitro diag-nostics analyzers.

Cont’d on page 10 Cont’d on page 6

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Rapid Ebolavirus TriageTest Introduced

AAnewly-introduced rapid Ebola-virus triage test enables health-

care workers, to test blood sampleseven in challenging environments.The test is designed to offer a uniquecombination of speed, sensitivity, ac-curacy and ease-of-use required foroutbreaks where time is of theessence.

Ablood test that measures three proteins produced bythe human immune system in response to exposure to

pathogenic microorganisms has beencommercialized into an as-say system capable of rap-idly distinguishing infectionscaused by bacteria fromthose caused by viruses.

Assay Measures 3 Human Response Proteins, Differentiates Bacterial and Viral Infections

®

Cont’d on page 4

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LabMedicaLabMedica

CChallenges faced by clinical laboratory point-of-care(POC) coordinators can now be more efficiently

tackled with an innovative approach developed as anew component of an informatics solution for manag-ing in vitro diagnostics (IVD) analyzers and operators.

Siemens Healthcare Diagnostics (Tarrytown, NY,USA; www.healthcare.siemens.com), now offers itsnew Ecosystem solution, an integrated component ofits RAPIDComm Data Management System, an infor-matics solution that centrally manages Siemens IVD an-alyzers and operators.

Ecosystem, which encompasses eight core compo-nents, includes device management, operator manage-ment, quality control, compliance reporting, competen-cy management, inventory management, remote moni-toring, and mobile access.

“Siemens Healthcare Diagnostics has been carefullyanalyzing the POC market and is ready to provide a ho-listic approach to testing,” said Afia Boamah, productmanager of Blood Gas, Stratus CS & POC IT S atSiemens Healthcare Diagnostics, “POC testing contin-ues to grow at a rapid pace and there is a strong needto provide fast and reliable results.” “Although solu-tions for each of the 8 core components do exist indi-vidually, efficiently managing all aspects of a POC test-

ing program requires close collaboration among hospi-tals, device manufacturers, and IT vendors. TheSiemens POC Ecosystem helps to address this challengeby implementing an integrated solution which im-proves the efficiency and effectiveness of POC pro-grams,” added A. Boamah.

Ecosystem takes the core needs of a POC programinto consideration with a focus on helping POC coordi-nators improve control, effectiveness, and transparency.It manages secure access to POC devices, overseesquality control, manages staff training, and identifiesand resolves issues - from any location via the remoteaccess facility. This helps ensure manageability of in-struments and consumables for potentially hundreds oftesting devices. External compliance requirements arealso met, while reducing costs.

“We are working hand-in-hand with healthcareproviders to adapt to clinical environments making useof handheld IT devices such as tablets and smartphones. The Ecosystem solution allows POC data man-agement from anywhere within a hospital using thesedevices, which improves the ability of POC coordinatorsto quickly and efficiently resolve issues. This has beenhighlighted by customers as a critical requirement in afast-paced laboratory environment,” said A. Boamah.

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Integrated Solution Enhances Point-of-Care Testing Networks

cont’d from cover

Bacterial and viral infections are often clinically indis-tinguishable, leading to inappropriate patient manage-ment and antibiotic misuse. Investigators at the biomed-ical company MeMed, Ltd. (Tirat Carmel, Israel; www.me-med.com) sought to identify novel viral-induced hostproteins that would complement bacterial-induced pro-teins to increase diagnostic accuracy and allow physi-cians to distinguish bacterial from viral infections.

To accomplish this task, they initially conducted abioinformatic screen to identify putative circulatinghost immune response proteins. The resulting 600 can-didates were then quantitatively screened for diagnos-tic potential using blood samples from 1,002 prospec-tively recruited patients with suspected acute infectiousdisease and controls with no apparent infection. Foreach patient, three independent physicians assigned adiagnosis based on comprehensive clinical and laborato-ry investigation including PCR for 21 pathogens. Thisprocess yielded 319 bacterial and 334 viral infections,112 healthy control patients, and 98 with indetermi-nate diagnoses. A further 139 patients were excludedfrom the study based on predetermined criteria.

Results revealed that the best performing host-pro-

tein was TNF-related apoptosis-inducing ligand(TRAIL), which was consistently upregulated in viral in-fected patients. They further developed a multi-proteinsignature using logistic-regression on half of the patientsand validated it on the remaining half. The signaturewith the highest precision included both viral- and bac-terial-induced proteins: TRAIL, interferon gamma-in-duced protein-10 (IP-10), and C-reactive protein (CRP).In the screening phase, host-proteins were measuredusing enzyme-linked immunosorbent-assay (ELISA),Luminex (Austin, TX, USA; www.luminexcorp.com)protein-arrays, and flow-cytometry. The three proteinsused in the final signature were measured as follows:CRP using the Roche (Pleasanton, CA, USA; http://molecular.roche.com) Cobas-6000, Cobas-Integra-400/800, or Modular-Analytics-P800; TRAIL and IP-10using commercial ELISA kits (MeMed Ltd.).

“We conducted big data filtering, followed by exten-sive screening of 600 immune system-related proteins,”said first author Dr. Kfir Oved, CTO of MeMed. “A fewof the proteins showed distinctly different patterns inbacterial and viral infected patients. In particular, themost informative protein we found, called TRAIL, dra-matically increased in the blood of patients infectedwith a wide range of viruses, but surprisingly, decreasedin bacterial infections. Our team developed an algo-rithm that computationally integrates TRAIL with otherimmune proteins to diagnose the cause of the infectionwith high accuracy.”

The MeMed ImmunoXpert in vitro diagnostic bloodtest is CE marked and approved for clinical use in theEuropean Union and Israel. It is currently in pilot distri-bution in these territories, with a broader commercialrollout planned for later this year. The paper was pub-lished in the March 18, 2015, online edition of thejournal PLOS ONE.

Assay Measures 3 Human Response Proteins,Differentiates Bacterial and Viral Infections


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EDITORIAL BOARDClaus Christiansen DenmarkHernán Fares Taie Argentina

Bernard Gouget FranceJocelyn M. Hicks United States

Anders Kallner SwedenTahir S. Pillay South Africa

Christopher Price United KingdomAndreas Rothstein ColombiaDmitry B. Saprygin RussiaRosa I. Sierra-Amor Mexico

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(Oxford, UK; www.ndph.ox.ac.uk) recruited patients over 16 years ofage undergoing non-emergency cardiac surgery to the clinical trial at17 UK hospitals. Participants with a hemoglobin (Hb) level of lessthan 9 g/dL after their operations were randomized to have a trans-fusion either when they became substantially anemic (transfuse whenHb is “low,” i.e., less than 7.5 g/dL) or straightaway, when they weremildly anemic (transfuse when Hb is “high,” i.e., less than 9 g/dL).

To compare the two transfusion strategies the medical team count-ed the number of patients who had a serious infection, stroke, heartattack, gut or kidney failure during the first three months after the op-eration. The trial analyzed information for 2,003 participants, aboutfour times more than the next largest similar trial of low and high

thresholds for transfusion in patientshaving heart surgery.

The scientists found almost all thepatients in the “high” group had ablood transfusion (92%) whereas justover half of the patients in the “low”group had a blood transfusion (53%).Slightly more patients had one or moreof the serious complications listedabove in the “low” group (35%) thanthe “high” group (33%). Moreover,more patients died in the “low” group(4.2%) than the “high” group (2.6%).This latter finding is clearly very impor-tant but it is difficult to interpret be-cause the trial was not primarily de-signed to compare the difference in thenumber of deaths. The restrictivethreshold was not superior to the liber-al threshold with respect to postopera-tive morbidity or total costs.

Barnaby C Reeves, DPhil, MSc, MF-PHM, a professor and lead author ofthe study, said, “Although only a hy-pothesis, the suggestion that it mightbe better rather than worse to trans-fuse patients who are only mildly ane-mic goes against the evidence aboutwhen to transfuse in non-cardiac sur-gery settings. Transfusing more ratherthan fewer patients would create achallenge for hospitals. With an agingpopulation and possibly an increase inheart disease, obesity and diabetes, itcan only become more difficult in thefuture to maintain the national bloodsupply in the UK and in other devel-oped countries around the world. Ourfindings emphasize the importance ofinterventions to reduce blood loss inthe first place.” The study was pub-lished on March 12, 2015, in the NewEngland Journal of Medicine (NEJM).

Image: A red blood cell transfusion afteran operation. Comparing two groups ofpatients, one which had transfusions ata low hemoglobin level and the otherwhich had transfusions at a higher he-moglobin level, a recent trial was carriedout to resolve uncertainty about when togive blood transfusions after heart sur-gery (Photo courtesy of the University ofBristol).


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cont’d from cover

from assays using glycoprotein allergen mixturesmay be inaccurate. However measuring IgEs specif-ic to individual peptide and carbohydrate epitopesof allergenic proteins is promising.

Chemists at the University of Connecticut(Storrs, CT, USA; www.uconn.edu) are developinga more advanced peanut allergy test that, based oninitial results, is many times more sensitive thancurrent procedures. The new test is capable of de-termining the potential intensity of a patient’s aller-gic reaction through just a few drops of blood.

In an allergic person who eats peanuts, their im-mune system releases an antibody protein knownas IgE. These antibodies fight off peanut allergenmolecules by binding to them and flushing themout of the body. The release of the antibodies caus-es tissue cells in the body to produce histamine,which in turn generates a variety of allergy symp-toms such as itchy skin, runny nose, coughing, orwheezing. The more antibodies that are released,the more histamine is generated, the stronger theperson’s allergic response.

The scientists created an immunoarray for IgEs

utilizing both peptide and carbohydrate epitopes. Asurface plasmon resonance imaging (SPRi) microar-ray was equipped with peptide and β-xylosyl glyco-side (BXG) epitopes from major peanut allergen gly-coprotein Arachis hypogaea h2 (Ara-h2). A mono-clonal anti-IgE antibody was included as positivecontrol. IgEs were precaptured onto magnetic beadsloaded with polyclonal anti-IgE antibodies to en-hance sensitivity and minimize nonspecific binding.

The binding of IgE antibody to allergen epitopeswas studied using a Surface Plasmon Resonance(SPR) imager (SPRimager II, GWC Technologies;Madison, WI, USA; www.gwcinstruments.com) in-terfaced with syringe pump and injection valve andsensor chip was assembled into the SPR imaging in-strument. The chemists then injected blood serumfrom patients known to have peanut allergies intothe array. As the blood serum floated over the sam-ples, IgE antibodies were pulled down by the aller-gens and bound by them. They could then measurethe quantity of antibodies to determine how stronga reaction a person would have to peanuts. To fur-ther refine the system, the team attached magneticbeads to the allergen samples.

James A. Rusling, PhD, a professor who led thestudy said, “A patient who has a serious allergy andgets exposed to an allergen protein will form anti-bodies in their body that should stay there for awhile. Our theory is that the level of those antibod-ies can be used to predict how severe a patient’s al-lergy is at any one point in time. Eventually, we’dlike to use maybe five different peptides and carbo-hydrate samples to see how these IgEs bind tothem. That way, we could determine a clear finger-print of a patient’s susceptibility to a specific aller-gen.” The study was originally published online onSeptember 16, 2014, in the journal the Analyst.

Ultrasensitive Test for Peanut Allergies



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Many PCR-based diagnostics are still considered time- and labor-intensivedue to disparate purification, amplification, and detection steps. Advance-ments in PCR enzymes and buffer chemistry have increased inhibitor toler-ance, facilitating PCR directly from crude samples. However, direct PCR pro-tocols have also traditionally employed thermal cyclers with slow ramp-ratesand conservative hold-times. The objective of the study was to reduce sam-ple preparation and assay time for a PCR-based genetic test by pairing an in-hibitor-resistant enzyme mix with a rapid thermal cycler for direct analysis ofwhole blood samples.

Scientists from Streck, Inc. (Omaha, NE, USA; www.streck.com) im-proved a genetic screening assay of DM1, a triple-repeat genetic disorder andthe most common adult form of muscular dystrophy, through adaptation of aconventional PCR by using Streck’s “PhilisaW Thermal Cycler” and NewEngland Biolabs’ inhibitor-resistant “NEB NextW High-Fidelity 2X PCR Mas-ter Mix.” Template sample was 10% whole blood. For detection agarose gelelectrophoresis or an Agilent 2100 Bioanalyzer was use. As a reference assay,Gene Link’s “Myotonic Dystrophy Genemer Kit” was used per the kit-specif-ic PCR protocol.

PCR amplification of the DM1 short tandem repeats was completed in 15minutes using 30 cycles, including in situ hot-start/cell lysis. Out of the 40donors screened, 23 (57.5%) were identified as DM1 negative. These resultswere 100% concordant with results using the reference kit.

The outcome is a simple exclusionary screening assay for DM1, independ-ent of up-front sample prep, with significant improvement in time-to-results.

This approach could also be applied to adapt other conventional PCR testswhere genomic DNA is targeted for analysis.

The paper, by Connelly C. et al., was published in the December 2014 is-sue of the journal BMC Medical Genetics.

Image: The Philisa Thermal Cycler is designed to greatly accelerate DNA testing.Shown are the men who invented the device: (from L) Hendrik Viljoen, Joel Ter-Maat, and Scott Whitney, with Matthew Kreifels (on R), who is Streck Inc.’s mo-lecular technology project manager (Photo courtesy of Streck).

PCR Assay for Myotonic Dystrophy Gene Targets




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The test uses 0.2 mL blood thatis added directly to the Idylla car-tridge, which contains all necessaryreagents on board for performingthe analysis on Biocartis (Mechelen,Belgium; www.biocartis.com) fullyautomated, molecular diagnosticssystem. A complete analysis of thesample takes around 90 minutesand can be operated by healthcareprofessional in most settings, in-cluding in the field, making the testideal for use in regions with limitedinfrastructure.

The Rapid Ebolavirus Triage Testwas developed in association withJanssen Diagnostics (Beerse, Bel-gium; www.janssendiagnostics.com)and the Institute for Tropical Medi-cine (Antwerp, Belgium; www.itg.be) for its Idylla system, a fully auto-mated molecular diagnostic platformthat is CE-IVD marked in Europe.The company believes its RapidEbolavirus Triage Test could providea sustainable solution for rapid detec-tion of Ebola-infected patients even

after the current Ebola outbreak. Af-ter testing of synthetic virus samplesin Belgium and the USA, Biocartishas now registered for field-testing inWest Africa to gather additional clin-ical evidence for the test perform-ance.

Rudi Pauwels, PhD, Biocartis’Chief Executive Officer comment-ed, “This test aims not only to im-prove the diagnosis of theEbolavirus for hard-pressed health-care professionals in the field, butto lay the foundations for a betterand faster diagnostic infrastructureafter the current outbreak has re-ceded, both in this region andaround the world. One of the les-sons of the Ebola outbreak hasbeen the urgent need for faster andmore accurate diagnostics. Biocar-tis is pleased to be working, along-side prestigious partners, on whatit believes could offer a viable solu-tion for healthcare workers aroundthe world to enable faster testingof infectious diseases in virtuallyany setting.”

Rapid Ebolavirus Triage Test Introduced


cont’d from cover

European CE approval, is manufac-tured by the EKF Diagnostics(Cardiff, United Kingdom; www.ekfdiagnostics.com) subsidiary Stan-bio Chemistry.

The GSP LiquiColor test is basedon a double enzymatic degradationmethod that utilizes the specificity offructosyl-amino oxidase to eliminateinaccuracies caused by non-glycatedprotein reducing substances, whichsignificantly interfere with the NBTfructosamine method. The test isavailable as a liquid-stable kit withcalibrator. It is suitable for use on a

variety of clinical chemistry analyz-ers, with on-board stability of up tofour weeks.

“GSP can provide a helpful supple-ment to glucose and HbA1c testing,when assessing glycemic control forthe management of diabetic patients,especially in cases where HbA1c maybe inaccurate,” said Al Blanco, busi-ness unit director at EKF Diagnostics.“GSP bridges the glycation gap,which is the difference between actu-al measured HbA1c and predictedHbA1c from glycated serum protein,to provide improved prediction of di-abetic complications.”

Diabetes Biomarker Kit Bridges the Glycation Gap

Image: The Idylla cartridge is designed for analysis on the company’s fullyautomated, molecular diagnostics system (Photo courtesy of Biocartis).

Image: The Stanbio Chem-istry GSP LiquiColor dia-betes biomarker assay(Photo courtesy of EKF Di-agnostics).

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AAn automated real-time polymerase chain re-action (PCR) assay for the detection of methi-

cillin-resistant Staphylococcus aureus (MRSA)and Staphylococcus aureus (SA) DNA directlyfrom nasal swabs has been certified for diagnosticuse in the United States.

The [US] Food and Drug Administration (FDA)has issued 510(k) clearance, which allows mar-keting as a diagnostic tool, for the Roche (Basel,Switzerland; www.roche.com) cobas MRSA/SATest for the early, simultaneous detection of MR-SA and SA directly from nasal specimens.

The cobas MRSA/SA assay was developedfor use on the cobas 4800 system. This systemwas designed to automatically perform real-timePCR for medium- to high-throughput laborato-ries (up to 384 samples a day). The system in-corporates fully automated sample preparationfrom primary vials with ready-to-use, load-and-

go reagents. No thawing or mixing is requiredand a full run of 94 samples can be set up in lessthan 20 minutes.

The cobas MRSA/SA Test joins the expandingUS system menu that currently includes the cobasCT/NG Test (chlamydia/gonorrhea), cobas HPVTest, cobas BRAF V600 Mutation Test, and thecobas EGFR Mutation Test.

“Healthcare-associated infections continue tobe a leading cause of mortality in US medical set-tings,” said Paul Brown, head of Roche Molecu-lar Diagnostics. “With the addition of the cobasMRSA/SA Test to our expanding menu of testsfor the cobas 4800 System, Roche offers labora-tories and clinicians a highly efficient molecularsolution to aid in the overall management andprevention of healthcare-associated infections,leading to lower costs for hospitals and optimalpatient care.”

Image: The cobas MRSA/SA test detects both tar-gets in a single sample run to deliver high quality re-sults in a matter of hours (Photo courtesy of Roche).

Automated MRSA/SA Test Receives FDA Certification

Newly-Discovered GenesInfluence Risk of

Developing Leprosy

LLeprosy, a chronic dermatological and neurologicaldisease, is caused by infection with Mycobacteri-

um leprae, and its manifestation, progression and prog-nosis are strongly associated with the proficiency of thepatient’s immune system.

The ability to predict the risk of contracting leprosycan help guide decisions made by public healthcarepolicymakers when drafting preventative measures forhigh-risk medical staff working in close contact withleprosy patients.

Scientists at the Genome Institute of Singapore (AS-TAR; Singapore; www.gis.a-star.edu.sg) conducted athree-stage genome-wide association studies (GWAS)of leprosy in the Chinese population. The genome-wide discovery analysis (stage 1) involved two inde-pendent data sets: a previously published GWAS dataset of 706 leprosy cases, 1,225 healthy controls and4,362 individuals with immune-related diseases aspopulation controls from northern China of ChineseHan descent and a new unpublished data set of 842leprosy cases and 925 controls from northern andsouthern China.

The second independent study was genotypedusing Human 660K-Quad BeadChips (Illumina; SanDiego, CA, USA; www.illumina.com). The scientistsdiscovered six new susceptibility loci, and furthergene prioritization analysis of these loci implicatedBasic Leucine Zipper Transcription Factor, ATF-Like3 (BATF3), Coiled-Coil Domain Containing 88B(CCDC88B) and Class II, major histocompatibilitycomplex, transactivator-Suppressor of cytokine sig-naling 1 (CIITA-SOCS1) as new susceptibility genesfor leprosy. They found the same genes linked to lep-rosy susceptibility also affect the level of aggressionexpressed by the immune system observed in au-toimmune and inflammatory diseases. A personwith an overly-aggressive immune system may havea good defense against infection, but stands a high-er risk of developing autoimmune diseases whereone’s own white blood cells attack healthy cells thatcan lead to death in severe cases.

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cont’d from cover

The CTC liquid biopsy and CRC genetic testwere developed by researchers from the Instituteof Bioengineering and Nanotechnology (IBN; Sin-gapore; http://www.ibn.a-star.edu.sg) of Singa-pore’s Agency for Science, Technology and Re-search (ASTAR). The standard approach tests sur-gically removed tissue for genotyping. If the can-cer has metastasized, additional samples are re-moved, which comes with additional pain, incon-venience, risk of acquired infection, and financialcosts. In contrast, IBN’s liquid biopsy enables test-ing blood samples, offering a relatively non-inva-sive alternative.

“We are excited about our liquid biopsy ap-proach, which could make it easier for doctors tocheck and administer the appropriate drug treat-ment for cancer patients. Our technologies havebeen validated by Fortis Surgical Hospital andhave been successfully licensed for clinical appli-cations,” said Prof. Jackie Y. Ying, executive direc-tor, IBN.

CTCs provide early indication of metastasis,but are extremely rare. IBN researchers fabricateda silicon microsieve to rapidly capture and enrichCTCs from blood. Measuring 7.5 mm in diameter,the microsieve utilizes a densely packed array of90,000 fine pores to separate CTCs (generallylarger and stiffer) from normal blood cells, within5 minutes. IBN’s microsieve can be used for rapiddetection and clinical analysis of CTCs and formetastasis research.

CRC is known to have two key mutated genes,KRAS and BRAF. IBN researchers developed ultra-sensitive molecular assays to identify mutationsusing the CTCs. The assays, tested on 44 CRCsurgery patients, were highly accurate in detect-ing KRAS and BRAF mutations, a major milestoneof the Fortis-IBN TissueBank, established to ad-vance translational research in colorectal care.

Dr. Min-Han Tan, IBN team leader and princi-pal research scientist, said: “Our work showsmatching genetic mutations in the tumor tissueand corresponding CTCs of patients with CRC.This opens up an avenue for liquid biopsies, or thetesting of cancer cells through blood, which wehope can reduce the need for invasive biopsies.”

The noninvasive genetic test was recently li-censed to AITbiotech Pte Ltd. (Singapore) for de-velopment into a ready-to-use kit. “We are pleasedto be IBN’s commercialization partner for thesetest kits. This is a good example of a win-win pub-lic-private partnership, whereby a local SME likeus is able to leverage on IBN’s expertise,” saidAITbiotech CEO Alex Thian. The microsievetechnology was licensed in 2011 to CellSievo PteLtd. (of IBN) for commercialization.

Dr. Poh-Koon Koh, senior consultant and di-rector, Colorectal Surgical Oncology & CancerGenetics Service, Fortis Surgical Hospital, andIBN adjunct clinician scientist, said: “In partner-ing IBN to set up the Fortis-IBN TissueBank, ouraim was to create a resource that will allow cut-

ting-edge research to benefit patients clinically.This liquid biopsy invention is an invaluable tool[and] allows a noninvasive means to obtain DNAmaterial in tumors that are not easily or safely ac-cessible through conventional biopsy tech-niques.”

The noninvasive genetic test for colorectal can-cer was reported by Mohd Suhaimi N.A. et al.,

online January 2015, in the journal MolecularOncology. The microsieve capture of CTCs fromwhole blood was reported by Lim L.S. et al., on-line August 2012, in the journal Lab on a chip.

Image: The silicon microsieve can rapidly capturecirculating tumor cells (CTCs) from blood within fiveminutes (Photo courtesy of the Institute of Bioengi-neering and Nanotechnology).

Noninvasive Diagnostic Test for Colorectal Cancer




PPatients who receive red blood cell transfu-sions during coronary artery bypass grafting

(CABG) surgery are at an increased risk of devel-oping pneumonia.

Pneumonia is a known risk following CABGsurgery, and developing it has been shown to sig-nificantly increase a patient’s risk of morbidity andmortality and previous studies have shown thatone in every 20 CABG patients develop a majorinfection, with pneumonia being the most com-mon type of infection.

Scientists at the University of Michigan HealthSystem (Ann Arbor, MI, USA; www.med.umich.edu) examined data on 16,182 patientswho underwent CABG surgery between 2011and 2013 at any of the 33 hospitals participatingin the Michigan Society of Thoracic and Cardio-vascular Surgeons Quality Collaborative. Among

participants in the study group, 6,451(39.9%) received red blood cell transfusionsand 576 (3.6%) developed pneumonia.

The scientists found a significant associa-tion between red blood cell transfusion andthe occurrence of pneumonia. They alsofound that the risk of developing pneumoniaincreased with the volume of red blood cellstransfused. Results showed that patients re-ceiving one or two units of red blood cellshad double the odds of developing pneumoniacompared to patients not receiving transfusion,while those who received six units or more of redblood cells had 14-fold increased odds of develop-ing pneumonia. The dose-dependent relationshipwas consistent across clinical subgroups and wasnot affected by other blood products, such asplatelets.

The study was presented at the 51st AnnualMeeting of The Society of Thoracic Surgeons,held January 24–28, 2015, in San Diego, CA,USA; www.sts.org).

Image: Recent studies suggest undergoing a bloodtransfusion during surgery increases the risk ofdeath (Photo courtesy of Garo / Phanie / Rex Fea-tures).

Blood Transfusions During Heart Surgery Increase Risk of Pneumonia


DNA Sequencing of Liquid BiopsySpecimens Raises Accuracy

Of Prostate Cancer Diagnosis

NNext-generation sequencing analysis of DNA inthe serum, a technique called liquid biopsy, can

distinguish between prostate cancer patients, normalindividuals, patients with benign hyperplasia, andthose with noncancerous prostatitis.

Genomic instability resulting in copy numbervariation is characteristic of malignant transforma-tion and may be identified through next-generationmassive parallel sequencing. Tumor-specific cell freeDNA (cfDNA) is released by dying cancer cells intothe serum and plasma where it provides a real time,easily accessible target for this approach.

Investigators at Vanderbilt University (Nashville,TN USA; www.vanderbilt.edu) extracted DNA fromserum of 204 patients with prostate cancer, 207male controls, 10 patients with benign hyperplasia,and 10 with prostatitis. DNA was amplified by use ofrandom primers, tagged with molecular identifiers,sequenced on a Life Technologies (Carlsbad, CA,USA; www.lifetechnologies.com) SOLID system,and aligned to the human genome.

Assessment of the results allowed the investiga-tors to establish a model that discriminated prostatecancer from controls with an AUC (area under thecurve) of 0.92 (0.87–0.95), reaching a diagnostic ac-curacy of 83%. Both benign prostatic hypertrophyand prostatitis could be distinguished from prostatecancer by use of cfDNA, with an accuracy of 90%.

“Based on the reported data and work inprogress, I believe the “liquid biopsy” will revolu-tionize cancer diagnostics, not only before a patientbegins therapy but also following patient responsesto therapy,” said contributing author Dr. WilliamMitchell, professor of pathology, microbiology, andimmunology at Vanderbilt University. “Since cell-freeDNA has a relatively short half-life in the circulation,sequencing of cell-free DNA soon after therapy maybe used to detect minimal residual disease in solid tu-mors.”

The study was published in the January 2015 is-sue of the journal Clinical Chemistry.



TThe β-cell killing that characterizes type 1 dia-betes (T1D) is thought to begin years before

patients present clinically with metabolic decom-pensation; however, this primary pathologicprocess of the disease has not been measured.

The kinetics of disease progression is limited be-cause there are no methods that directly measureβ-cell death, but a method has been recently de-veloped for assessing β-cell death in vivo by meas-uring the relative amount of β-cell-derived un-methylated insulin (INS) DNA in the circulation.

A team of scientists led by those at Yale Univer-sity (New Haven, CT, USA; www.yale.edu) per-formed an observational study of 50 participantsfrom two cohorts at risk for developing T1D fromthe TrialNet Pathway to Prevention study and offour subjects who received islet autotransplants.DNA was purified from serum samples using QI-Aamp DNA Blood Kits (Qiagen; Venlo, TheNetherlands; www.qiagen.com).

Analysis of β-cell death was carried out bymeasuring the levels of unmethylated INS DNA bydroplet digital polymerase chain reaction (ddPCR).The DNA content of the droplets was analyzedwith a QX100 Droplet Reader (Bio-Rad; Hercules,CA, USA; www.bio-rad.com). Plasma C-peptidelevels were measured using the Tosoh AIA 1800assay (Tokyo, Japan; www.tosoh.com).

In at-risk subjects, those who progressed toT1D had average levels of unmethylated INS DNAthat were elevated modestly compared with thoseof healthy control subjects. In at-risk individualsthat progressed to T1D, the observed increases inunmethylated INS DNA were associated with de-creases in insulin secretion, indicating that thechanges in unmethylated INS DNA are indicativeof β-cell killing. Subjects at high risk for T1D hadlevels of unmethylated INS DNA that were higherthan those of healthy controls and higher than thelevels of unmethylated INS DNA in the at-risk pro-

gressor and at-risk non-progressor groups followedfor four years. Evaluation of insulin secretory kinet-ics also distinguished high-risk subjects who pro-gressed to overt disease from those who did not.

The authors concluded that that a blood testthat measures unmethylated INS DNA serves as amarker of active β-cell killing as the result of T1D-associated autoimmunity. Together, the data sup-port the concept that β-cell killing occurs sporadi-cally during the years prior to diagnosis of T1D andis more intense in the peridiagnosis period. Thestudy was published on February 2, 2015, in theJournal of Clinical Investigation.

Simple Method Monitors β-Cell Death in Type 1 Diabetes Individuals


Platelet Transfusions for Rare Blood Cell Disorders Increases Mortality Risk

PPatients hospitalized with certain rare blood celldisorders frequently receive a treatment that is

associated with a two- to fivefold increase in death.The risks and benefits associated with platelet

transfusions have been studied in the rare blood dis-orders thrombotic thrombocytopenic purpura (TTP),heparin induced thrombocytopenia (HIT) and im-mune thrombocytopenic purpura (ITP).

Medical experts in transfusion medicine at theJohns Hopkins University School of Medicine (Balti-more, MD, USA; www.hopkinsmedicine.org) carriedout a nationwide review of nearly 100,000 com-bined hospital admissions for three rare blood celldisorders: TTP, HIT and ITP. All three conditions areimmune system disorders marked by low levels ofplatelets that help seal up damaged blood vessels.TTP is a life-threatening condition in which clotsform in small blood vessels, resulting in a low over-all platelet count. It occurs in less than one out ofevery 100,000 people per year. ITP is a less serioustendency to bleeding, seen in about one in every20,000 children and one in every 50,000 adults,which often clears up on its own. HIT is a life-threat-ening reaction to the drug heparin, given to patientsto prevent the formation of blood clots.

Platelet transfusions were reported in 10.1% of allhospitalizations for TTP, 7.1% for HIT and 25.8% forITP. In TTP, the odds of dying in the hospital doubledwhen the patient was given a platelet transfusion. InHIT, the odds of dying were five times greater with aplatelet transfusion.

The scientists found that one in 10 TTP patientsand one in 13 HIT patients got platelet transfusions,in spite of some practitioners’ concerns about therisks. In some cases, the doctors may not haveknown the patient has a platelet disorder until theysee the potentially deadly reaction to the transfusion.

Aaron A. R. Tobian, MD, PhD, an associate pro-fessor of pathology, said, “Because these conditionsare so rare, they’re difficult to study. There was somesuggestion that transfusion may be harmful in theseconditions, but it really was not known until now.Our study is the first one to show that platelet trans-fusions are frequently administered to patients withITP, HIT and TTP, and that they’re associated withhigher odds of arterial blood clots and mortality inTTP and HIT.” The study was published on January14, 2015, in the journal Blood.

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RR apid, accurate detection of Mycobacterium tuberculosis is crucial inthe diagnosis of tuberculosis (TB), but conventional diagnostic meth-

ods have limited sensitivity and specificity or are time consuming. A newhighly sensitive nucleic acid amplification (NAA) test, combined nestedand real-time polymerase chain reaction (PCR) in a single tube, one-tubenested real-time PCR, was developed for detecting M. tuberculosis,which takes advantages of two PCR techniques, including real-time PCR.

Biomedical Laboratory Scientists at Yonsei University (Wonju, Republicof Korea; www.yonsei.ac.kr) and their colleagues collected sputum speci-mens from 167 subjects having active TB and from 108 healthy subjects.Sputum specimens were liquefied and processed and the sediment weresuspended in sterile saline and used for smear preparation, inoculation in-to Löwenstein-Jensen (LJ) media and DNA extraction. The presence ofacid fast bacilli (AFB) was examined using a light microscope and the re-sults of AFB smear were graded.

Initial identification of M. tuberculosis was confirmed using the SD TBAg MPT64 immunochromatographic test (SD Bi-oline Inc.; Yongin, Korea; www.standardia.com)and the REBA Myco-ID molecular diagnostic kit(M&D Inc.; Wonju, Korea; www.mndkorea.com).The scientists designed a one-tube nested real-time PCR to have two sequential reactions withtwo sets of primers and dual probes for theIS6110 sequence of M. tuberculosis in a singleclosed tube. A real-time PCR assays were per-formed and validated using an Applied Biosystems7500 Fast Real-time PCR System (Foster City, CA,USA; www.appliedbiosystems.com).

The minimum limits of detection of IS6110real-time PCR were 100 fg/μL and for theIS6110 one-tube nested real-time PCR it was 1fg/μL of M. tuberculosis DNA. AdvanSureTB/NTM real-time PCR (LG Life Science; Seoul,Korea; www.lgls.com), IS6110 real-time PCR,and one-tube nested real-time PCR showed 100%sensitivity and 100% specificity for clinical M. tu-berculosis isolates and nontuberculous mycobac-teria (NTM) isolates. In comparison, the sensitiv-ities of AdvanSure TB/NTM real-time PCR were91% (152/167), 94.6% (158/167) for the singleIS6110 real-time PCR, and 100% (167/167) one-tube nested real-time PCR.

The authors concluded that the new efficient,highly sensitive PCR assay, one-tube nested real-time PCR targeting IS6110 sequence that was de-veloped for detecting M. tuberculosis, utilizesthe advantages of nested PCR and real-time PCR.One-tube nested real-time PCR showed superiorsensitivity to conventional real-time PCR and Ad-vanSure TB/NTM real-time PCR, a commercialTB real-time PCR kit. The study was publishedon August 30, 2014, in the journal DiagnosticMicrobiology and Infectious Disease.

Image: Mycobacterium tuberculosis, the organismresponsible for tuberculosis in humans (Photo cour-tesy of the CDC).

Highly Sensitive Molecular Test Developed For Tuberculosis


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AAnew CE-IVD certified molecular test providesrapid, accurate, single-test detection of toxi-

genic Clostridium difficile without the need forconfirmatory retesting.

Greiner Bio-One International GmbH (Fricken-hause, Germany, and Kremsmünster, Austria;www.gbo.com) has now added the Genspeed C.diffOneStep assay to its growing portfolio of CE-IVDcertified molecular diagnostic tests for nosocomialinfections. Genspeed C.diff OneStep identifies toxi-genic C. difficile by combining detection of 4 bio-markers: glutamatdehydrogenase (GDH), Toxin A,Toxin B, binary toxin in a single test. Completeanalysis takes under 100 min (depending on PCR-cycler used), including detection on the GenspeedR2 Analyzer.

Genspeed C.diff OneStep’s new “1-test – 4-re-sults” procedure avoids the currently used sequen-

tial 2-step procedures that combinedifferent test systems and assay prin-ciples for GDH and the C. difficiletoxins. It also provides conclusive re-sults without the need for confirma-tory re-testing and enables inter-labo-ratory comparisons of results.

Ready-to-use reagents and auto-mated dispensing minimize the num-ber of manual processing steps within the work-flow. The Genspeed R2 Analyzer represents a reli-able solution that is virtually service-free system,simple to operate, and available at an attractivecost-benefit ratio.

The new test addresses one of the most seriousthreats worldwide as C. difficile causes one of themost common serious healthcare system associatedinfections. In a 2013 report, the USA Center for

Disease Control (CDC) categorized C. difficile in-fections as “Threat Level Urgent,” the highest levelavailable.

All Genspeed products are currently available forsale in the EU and EFTA countries only.

Image: The Genspeed C.diff OneStep ‚Äì a rapid newmolecular test that accurately diagnoses toxigenicClostridium difficile in a single assay (Photo courtesyof Greiner Bio-One).

New Test Diagnoses C. difficile With One Assay and No Retesting

Test Detects Both Parvovirus B19 and

Hepatitis A in Plasma

AACE-marked molecular duplex test, for use onCobas 6800/8800 systems, helps increase

safety of human blood and plasma products by si-multaneous screening for parvovirus B19 (B19V)and hepatitis A virus (HAV).

Nucleic acid amplification testing (NAT) en-ables detection of active viral infections earlierthan conventional immunoassays. Roche (Basel,Switzerland; www.roche.com) now offers the“cobas DPX” real-time PCR test for use on itscobas 6800/8800 systems, expanding the menuof these latest diagnostic platforms with next-gen-eration donor-screening assays.

“Roche is committed to providing the broadestcoverage and most efficient blood and plasmascreening tests to ensure the highest safety for pa-tients,” said Paul Brown, head of Roche Molecu-lar Diagnostics, “Introducing cobas DPX to thecobas 6800/8800 Systems is an important step to-ward that goal, complementing our current donor-screening tests for the detection of HIV, HCV,HBV, WNV and HEV.” Performing NAT withcobas DPX increases the processing efficiency ofdonations while preserving high safety standardsfor plasma products. Cobas DPX enables bloodand plasma testing centers to quickly identify andremove HAV-contaminated units, while simultane-ously minimizing the B19V burden in plasmapools.

The cobas 6800 and 8800 systems (mediumand high throughput models, respectively) are au-tomated solutions designed for more efficientblood-donor screening, viral load monitoring,women’s health and microbiology testing. Bothsystems enable long “work-away” (minimal user-interaction) times, and allow for mixed batching,enabling up to three tests in the same run with nopre-sorting required.

The cobas DPX and cobas 6800/8800 systemsare available where the CE-marking is recognized.


AAmicroarray-based rapid diagnostictest, which includes targets for 12

bacterial species and three resistance de-terminants, has been compared to rou-tine microbiologic methods for diagnos-tic accuracy.

Overall mortality in patients withGram-positive bacteremia ranges from10% to 40%, with delays in effective an-timicrobial therapy leading to a dramaticincrease in mortality and patients withGram-positive bacteremia also often suf-

fer from substantial long-term morbidityas a result of prolonged hospitalizationand generalized deconditioning.

Scientists at the University of Hous-ton (TX, USA; www.uh.edu) and theircolleagues examined blood cultures sub-mitted as part of routine clinical care toa 650-bed tertiary care hospital. Allblood cultures with Gram stain identifi-cation of Gram-positive cocci betweenOctober and December 2013 wereprospectively screened for eligibility.Blood cultures were obtained usingBacT/ALERT (bioMérieux; Durham,NC, USA; www.biomerieux-usa.com)aerobic (FA) and anaerobic (SN) bloodculture bottles and incubated in the bio-Mérieux BacT/ALERT 3D automaticmonitoring system.

The Verigene Gram-positive bloodculture assay (BC-GP, Nanosphere, Inc.; Northbrook, IL, USA; www.nanosphere.us) is a microarray-basedrapid diagnostic test that identifies mo-lecular target through DNA extractionand subsequent hybridization to comple-mentary oligonucleotides present on themicroarray grid. A secondary oligonu-cleotide affixed to a gold nanoparticle isthen hybridized to captured bacterialDNA, and the target is identifiedthrough analysis of the relative opticaldensity of the probes on the panel. Totalhands-on time was approximately 10minutes with a 2.5-hour test run time.

A total of 143 consecutive patientswith Gram-positive bacteremia were in-cluded in the analysis. BC-GP correctlyidentified 127/128 (99.2%) of organ-isms from monomicrobial blood cul-tures and 9/14 (64.3%) from polymi-crobial, including all methicillin-resist-ant Staphylococcus aureus and van-comycin-resistant enterococci. Steward-ship interventions were possible in51.0% of patients, most commonly stop-ping or preventing unnecessary van-comycin or starting a targeted therapy.

The authors concluded that the BC-GP is a potentially useful tool for antimi-crobial stewardship programs to im-prove the care of patients with Gram-positive bacteremia. In Monte Carlosimulations, unnecessary antibioticscould be stopped at least 24 hours earli-er in 65.6% of cases, and targeted ther-apy could be started at least 24 hoursearlier for 81.2% of the patients. Thestudy was published in the January2015 issue of the journal Diagnostic Mi-crobiology and Infectious Disease.

Image: The Verigene Gram-positiveblood culture assay system (Photo cour-tesy of Nanosphere).

Rapid Diagnostic Test Evaluated for Gram-Positive Bloodstream Infections



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VV iral hepatitis is the most prevalent infectious disease in Japan,affecting some three million people and left untreated, the con-

dition can develop into severe illness as it progresses toward livercell carcinoma.

As chronic hepatitis advances toward liver cell carcinoma, theamount of fiber-rich tissue in the liver increases and hepatic functiongradually declines. An important part of the treatment process for vi-ral chronic hepatitis is determining the degree of hepatic fibrosis. Thetypical testing process involves taking a biopsy of the liver tissue, re-quiring a patient to be hospitalized because of its high invasiveness.This places a substantial burden on the patient on both the physicaland economic fronts.

A hepatic fibrosis test reagent called HISCL M2BPGi Assay Kit (Sys-mex; Kobe, Japan; www.sysmex.co.jp)was developed for testing the degree ofviral hepatitis-induced disease duringblood testing and is to be used on auto-mated immunoassay systems – the Sys-mex HISCL-Series HISCL-5000/2000i/800. The assay requires only ablood sample to determine within justabout 17 minutes the status of progres-sion of hepatic fibrosis to chronic hep-atitis and cirrhosis of the liver, whichhas been suspected to be a cause of he-patocellular carcinoma. The hepatic fi-brosis test reagent HISCL M2BPGi As-say Kit has been approved for insur-ance coverage domestically as of Janu-ary 1, 2015.

The assay measures Mac-2 BindingProtein (M2BP) Glycosylation isomerand uses a chemiluminescent enzyme-linked immunoassay using a two-stepsandwich method. Sugar chains, thelinked monosaccharides that link to thesurface of a cell or a protein, are some-times described as “cell and proteincostumes.” Their roles include thetransmission of information specific toindividual cells and intercellular com-munications. A glycosylation marker isa biomarker that targets structuralchanges in sugar changes present inglycoproteins. The product will be in-troduced to the domestic market withthe focus on medical facilities and diag-nostic centers. Introductions to Asiancountries, specifically China with itslarge number of liver disease patients,will follow in order.

Image: The HISCL-2000i automated im-munoassay system (Photo courtesy ofSysmex).

Blood Test Measures Hepatic Fibrosis Progression





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PP lasmodium ovale subspecies are similar basedon morphology and geographical distribution,

but allelic differences indicate that P. ovale curtisiand P. ovale wallikeri are genetically divergent.

Potential clinical and latency duration differ-ences between P. ovale curtisi and P. ovale wallikeridemonstrate the need for investigation into the con-tribution of this neglected malaria parasite to theglobal malaria burden.

Scientists at the Uniformed Services University(Bethesda, MD, USA; www.usuhs.mil) workingwith colleagues in Kenya, collected whole bloodsamples from clinically healthy asymptomatic adultindividuals in Nyanza Province, Kenya. The sam-ples were screened with the Parascreen Pan/Pfmalaria Rapid Diagnostic Test (Zephyr Biomedicals,Verna, Goa, India; www.tulipgroup.com) for thepresence/absence of malaria parasites from Marchthrough September of 2008. Thin and thick smearswere examined subsequently by up to five expert

microscopists for malaria species designation andestimation of quantitative Parasitemia.

The 22 samples identified as positive for P. ovalevia microscopy, in which all were mixed infectionswith other malaria species, were targeted for DNAextraction and polymerase chain reaction (PCR)based analysis. The team used multilocus genotypingto discriminate P. ovale curtisi and P. ovale wallikeriand all conventional PCRs were performed on a DNAEngine PTC-200 Thermal Cycler (MJ Research;Waltham, MA, USA; www.mj-research.com). Real-time PCR were conducted on the on the ABI 7500fast real-time PCR (qPCR) platform (Life Technolo-gies; Carlsbad, CA, USA; www.lifetechnologies.com).

Alignments of tryptophan-rich antigen (tra) genesequences revealed nine samples (40.9%) positivefor P. ovale curtisi type 1, two samples (9.1%) posi-tive for P. ovale curtisi type 2, six samples (27.3%)positive for P. ovale wallikeri type 1, and three sam-ples (13.6%) positive for P. ovale wallikeri type 2.

Specificity studies showed the ability of the reticu-locyte binding protein 2 (rbp2) qPCR assays to de-tect low-levels of P. ovale in the presence of addi-tional malaria parasite species, including P. falci-parum, P. vivax, and P. malariae. The team identi-fied P. ovale curtisi and P. ovale wallikeri in West-ern Kenya by DNA sequencing of the tryptophan-rich antigen gene, the small subunit ribosomal RNAgene, and the rbp2 gene.

The authors concluded that their novel P. ovalerbp2 qPCR assay detects P. ovale curtisi and P. ovalewallikeri simultaneously and can be utilized to char-acterize the prevalence, distribution, and burden ofP. ovale in malaria endemic regions. The use of mul-tilocus genotyping also provided the first descriptionof the prevalence of P. ovale curtisi and P. ovale wal-likeri in Western Kenya, a region holoendemic formalaria transmission. The study was published onJanuary 15, 2015, in the journal Public Library ofScience Neglected Tropical Diseases.

Neglected Malaria Subspecies Characterized by Novel Molecular Assay

AAn advance in compact robotic laboratory au-tomation solutions, a new instrument consoli-

dates sample management for chemistry and im-munoassay testing and achieves some of the work-flow benefits of automation without the space orbudget associated with a track-based solution.

Siemens Healthcare Diagnostics (Tarrytown, NY,USA; www.healthcare.siemens.com) has unveiledthe VersaCell X3, featuring increased analytical ca-pacity through a single sample interface with three-instrument connectivity. The one-touch samplemanagement empowers laboratories to advanceworkflow capabilities and streamline processes tomeet their needs. With advanced sorting capabili-ties, the VersaCell X3 can improve the pre- andpost-analytical process and reduce operator hands-on-time.

A priority drawer provides 8 new STAT posi-tions and frees up 50 sample positions for routine

processing, increasing sample routing flexibility. Itssignature robotic arm delivers individual samplesto connected analyzers to help drive towards a pre-dictable turnaround time. The inclusion of a newdocking plate reduces service intervention time forall connected systems, supporting uptime so labo-ratories can deliver timely results to clinicians. Fur-ther data consolidation is achievable through aconnection to Siemens’ “CentraLink Data Manage-ment System.”

“The VersaCell X3 is a new design which pro-vides enhanced capabilities and a harmonized lookand feel across our next generation of solutions,”said Catherine Spurgeon, marketing manager forAutomation, Siemens Healthcare Diagnostics, “Inline with our commitment to continuously advanceworkflow capabilities, some of our existing Versa-Cell Systems can be upgraded with the VersaCell X3Expansion Pack.”

Image: The VersaCell X3 compact, robotic laboratoryautomation solution (Photo courtesy of SiemensHealthcare).

Robotic Solution Enhances Workflow within Compact Footprint

HEMATOLOGY ANALYZERDymind Biotech

The DH-56 features a triangle semi-conductorlaser scatter combined with chemical dye method,and advanced flow cytometry. Other benefits in-clude 5-part differentiation, 29 parameters, only20-µL sample volume, throughput of 60 samplesper hour, and storage for 100,000 sample results.

MOLECULAR DIAGNOSTICS SYSTEMELITechGroup

The ELITe InGenius performs NA extraction/purifi-cation from a large panel of biological specimens,amplification/detection of the NA extracted by RT-PCR, and result analysis. The system offers atouch screen guide, and can process from 1 to 12samples in parallel and independent tracks.

CLINICAL DIAGNOSTICS SYSTEMHologic

The Panther system features random access andcontinuous loading of molecular samples,reagents and consumables. The system offerswalkaway freedom and is designed to improve labproductivity, accelerate results and help enhancepatient care, all while reducing lab costs.




AA new test may reveal which patients will re-spond to treatment for graft versus host dis-

ease (GVHD), an often life-threatening complica-tion of stem cell transplants used to treat leukemiaand other blood disorders. Patients with fatalblood cancers like leukemia often require allo-genic stem cell transplants (SCT) to survive andwhen these donor stem cells are transplanted to arecipient, there is a risk of developing GVHD, alife-threatening complication and major cause ofdeath after SCT.

Scientists at the Icahn School of Medicine atMount Sinai (New York, NY, USA; www.icahn.

mssm.edu) working with a multicenter team, de-veloped and tested a new scoring system using al-most 500 patient blood samples with newly diag-nosed GVHD in varying grades from two differentcenters between April 13, 2000, and May 7, 2013.They used three validated biomarkers, tumornecrosis factor receptor 1 (TNFR1), suppression oftumorigenicity 2 (ST2) and regenerating gene fami-ly protein 3 (Reg3 ), to create an algorithm thatcalculated the probability of non-relapse mortalitythat is usually caused by GVHD that provided threedistinct risk scores to predict the patient’s responseto GVHD treatment.

James L. M. Ferrara, MD, DSc, a senior au-thor of the study, said, “This new scoring systemwill help identify patient who may not respondto standard treatments, and may require an ex-perimental and more aggressive approach. It willalso help guide treatment for patients with low-er-risk GVHD who may be over-treated. This willallow us to personalize treatment at the onset ofthe disease. Future algorithms will prove increas-ingly useful to develop precision medicine for allSCT patients.” The study was published on De-cember 23, 2014, in the journal the LancetHematology.

Test Predicts Treatment Response to Leukemia Stem Cell Transplants

SSevere Combined Immunodeficiency (SCID) is agroup of disorders caused by defects in genes in-

volved in the development and function of T-cellsand other infection-fighting immune cells. Newbornswith SCID appear normal at birth, but typically de-velop life-threatening infections within a few monthsand without early intervention and treatment, deathcan occur within the baby’s first year so early detec-tion and treatment can markedly improve survival.

The first screening test has now been permitted tobe marketed by the US Food and Drug Administra-tion (FDA; Silver Springs MD, USA; www.fda.gov)for Severe Combined Immunodeficiency (SCID) innewborns. A few drops of blood taken from the new-born’s heel, which is dried on filter paper, the test candetermine whether a certain type of DNA, known asT-cell receptor excision circles (TREC DNA), is lowor missing from the newborn’s blood. Newbornswith SCID typically have zero or low amounts ofTREC DNA compared to healthy infants. Additionaltesting is required to obtain a SCID diagnosis.

The FDA reviewed the test through its de novoclassification process, a regulatory pathway for somenovel low- to moderate-risk medical devices that arenot substantially equivalent to an already legally mar-keted device. The review included a clinical study of

approximately 6,400 blood spot speci-mens from routine screening of new-borns, 17 of which had confirmed SCIDdiagnosis. The EnLite Neonatal TRECKit (PerkinElmer; Waltham, MA, USA;www.perkinelmer.com) correctly identi-fied all 17 SCID cases. The agency alsoevaluated the test’s ability to accuratelydistinguish low TREC DNA numbersthat would be observed in newbornswith SCID, from high TREC DNA num-bers that would be present in healthynewborns. The FDA found that the En-Lite Neonatal TREC Kit could adequate-ly detect very low TREC DNA valuesthat are associated with SCID.

Alberto Gutierrez, PhD, director ofthe Office of In Vitro Diagnostics and RadiologicalHealth at the FDA, said, “SCID is a fatal diseasethat can be treated with early intervention, includ-ing screening. For the first time, the FDA is allow-ing the marketing of a newborn screening test thatwill enable states to incorporate an FDA reviewedSCID test into their standard newborn screeningpanels and allow earlier identification for affectedindividuals.” The EnLite Neonatal TREC Kit is not

intended for use as a diagnostic test or to screen forSCID-like syndromes, such as DiGeorge Syndromeor Omenn Syndrome. It is also not intended toscreen for less acute SCID syndromes, such asleaky-SCID or variant SCID.

Image: The EnLite neonatal TREC kit for severe com-bined immunodeficiency screening (Photo courtesy ofPerkinElmer).

Newborn Screening Test Detects Severe Combined Immunodeficiency

LIQUID HANDLING PRODUCTSKarl Hecht

The wide range of Assistent liquid handling prod-ucts available are specifically designed to pipetteor dispense nearly all kinds of liquids, even ag-gressive liquids, from 5 µL up to 100 mL. Theuser-friendly products combine the highest preci-sion with simple operation for enhanced reliability.

COAGULATION SYSTEMSekisui Diagnostics

The CP3000 offers a high-throughput and a com-pact footprint with a menu of dedicated reagents,the majority in liquid format. The 400 PT per hourthroughput and rapid result turnaround time en-able the system to meet the needs of labs of allsizes, providing high quality and reliable results.

INTEGRATED SYSTEMSNIBE

The BIOLUMI 8000 modular IVD lab analytical sys-tem combines immunology (280 tests/h), biochem-istry (1,600 tests/h), electrolyte (1,000 tests/h) andsample handling modules (280 samples) together.The full expansion and flexible recombination areintended to satisfy all lab requirements.




ULTRA-LOW TEMPERATURE FREEZERThermo Fisher Scientific

The TSX with V-Drive features natural refrigerantsfor lower environmental impact and higher coolingefficiency. The TSX freezer uses up to 50 percentless energy than conventional refrigerant ultra-lowfreezers, and delivers temperature uniformity thatcontinuously adapts to a lab’s environment.

INFECTIOUS DISEASE TESTVircell

The VirClia Monotest offers ready-to-use reagentsand provides flexibility and easy handling to clini-cal labs. The test allows pipetting from primarysample tube, with no further manipulation needed,and can perform 24 tests of different parameterssimultaneously with results in 50 minutes.

POCT ANALYZERWondo Biotech

The Finecare FIA plus features a fluorescence im-munochromatographic analyzing system. It is de-signed to test more than 14 items such as CRP,PCT, HbA1c and cardiac marker in human bloodor urine within several minutes, and help to diag-nose a wide range of conditions.

AAmutation in a gene has been found that mayserve as a biomarker for the rare adrenal tu-

mors pheochromocytomas and paragangliomas thatbecome malignant.

Pheochromocytomas and paragangliomas(PCC/PGL) are tumors of the autonomic nervoussystem arising from the adrenal medulla and extra-adrenal ganglia, respectively. PCC/PGL are morecommonly associated with inherited susceptibilitygene mutations than any other solid tumor.

Scientists at the Perelman School of Medicine(Philadelphia, PA, USA; www.med.upenn.edu)used a set of 21 PCC/PGL that were selected torepresent clinically benign and clinically aggres-sive tumors. Fresh-frozen PCC/PGL were sec-tioned and stained with hematoxylin and eosin toensure sections of over 70% tumors are used for

DNA extraction. Germline DNA from blood orsaliva was extracted using standard protocols inthe laboratory.

All DNA was quantitated with a Qubit fluorom-eter (Life Technologies; Carlsbad, CA, USA;www.lifetechnologies.com). To ensure high-qualitygenomic DNA, the A260/280 ratio was measuredon a Nanodrop (Wilminton, DE, USA; www.nanodrop.com) and DNA was run on a 1% agarosegel. Whole-exome sequencing was performed onfresh-frozen tumor and matched germline DNA andDNA quality and fragment size were measuredwith an Agilent 2100 Bioanalyzer (Santa Clara, CA,USA; www.agilent.com) and concentration meas-ured with a Qubit fluorometer.

The team reported that somatic alpha tha-lassemia/mental retardation syndrome X-linked

(ATRX) mutations were identified in two of sevensuccinate dehydrogenase complex, subunit B, ironsulfur (SDHB)-associated tumors. To determine thefrequency of somatic ATRX mutations in PCC/PGL,the team sequenced the ATRX coding region in aseparate set of 103 tumors samples. They foundthat 13% of tumors had ATRX mutations.

The authors concluded that although the sampleset of PCC/PGL with ATRX variants is too small toidentify statistically significant associations, manyhad clinically aggressive features, inherited succi-nate dehydrogenase (SDHx) mutations and alterna-tive lengthening of telomeres (ALT), suggesting aninteraction between the somatic and inheritedgenomes in solid cancers, which needs to be inves-tigated further. The study was published on January21, 2015, in the journal Nature Communications.

Mutated Gene Biomarker Identified for Rare Adrenal Tumors

AA team of bioengineers has presented a proto-type “proof-of-concept” version of a tempo-

rary tattoo that is able to extract and measure thelevel of glucose in the fluid between human skincells.

The flexible, easy to wear device consists of apattern of electrodes printed on temporary tattoopaper that is attached to the skin. When a mildelectrical current is applied to the skin for about10 minutes, sodium ions and glucose molecules inthe interstitial fluid migrate toward the tattoo’selectrodes. A sensor built into the tattoo measuresthe strength of the electrical charge produced bythe glucose to determine the patient’s overall glu-cose level.

In a preliminary study, tattoos were applied toseven men and women between the ages of 20and 40 with no history of diabetes. The volunteerswere fed a carbohydrate-rich meal, and glucoselevels were monitored by the tattoo and comparedto those obtained by the traditional finger-stickmethod. Results showed that the tattoos detected

the glucose spike following themeal with the same level of accu-racy as the finger-stick.

“The concentration of glucoseextracted by the noninvasive tat-too device is almost hundredtimes lower than the correspon-ding level in the human blood,”said first author Amay Bandod-kar, a graduate researcher at theUniversity of California, SanDiego (USA; www.ucsd.edu).“Thus we had to develop a high-ly sensitive glucose sensor that could detect suchlow levels of glucose with high selectivity. Eventu-ally the instrument will also have Bluetooth read-out capabilities to send this information directly tothe patient’s doctor in real-time or store data in thecloud. Presently the tattoo sensor can easily sur-vive for a day. These are extremely inexpensive –a few cents – and hence can be replaced withoutmuch financial burden on the patient.”

The paper describing the potential for glucosemonitoring with a noninvasive flexible tattoo waspublished in the December 12, 2014, online edi-tion of the journal Analytical Chemistry.

Image: A researcher at the University of California inSan Diego has developed a temporary tattoo that isproving to be just as accurate at reading glucosemeasures as a traditional finger-stick needle device(Photo courtesy of UCSD).

Bioengineers Present Glucose Monitor Tattoo Prototype




TT uberculosis (TB) is caused by the Mycobacterium tuberculosis

complex (MTB-complex) and usuallyattacks the lungs and many peoplecarry the MTB-complex bacteria with-out ever developing active disease.

Current TB infection controlguidelines recommend placing a pa-tient suspected of having active TB inan airborne infection isolation roomand keeping that person isolated untilclinical and laboratory information,including acid-fast bacilli (AFB) smeartesting of three sputum specimens,each collected eight to 24 hours apartshow that the patient is unlikely tohave contagious TB.

The US Food and Drug Adminis-tration (FDA; Silver Springs, MD,

USA; www.fda.gov) has cleared amolecular assay that helps physiciansdetermine if patients with suspectedTB can be removed from airborne in-fection isolation. This expanded useallows healthcare providers to useone or two negative assay test resultsto help them determine whether apatient showing signs and symptomsof pulmonary TB should continue tobe kept in a hospital airborne isola-tion room.

The Xpert MTB/RIF Assay (Ce-pheid, Sunnyvale, CA, USA; www.cepheid.com) is a nucleic acid amplifi-cation test, different from a smear inthat it can test specifically for the DNAof the mycobacteria that cause TB. Thistest can detect TB better than the

smear test, and can detect TB evenwhen the smear test may be negative.Because the MTB/RIF test can detectTB better than the smear, results fromone or two MTB/RIF tests can be usedin the decision to remove patients fromisolation. A single negative MTB/RIFtest result predicted the absence ofMTB-complex on AFB smears 99.7% ofthe time, and two consecutive negativeMTB/RIF test results predicted the ab-sence of the bacteria 100% of the time.

Philip LoBue, MD, director of theCenter for Disease Control’s Divisionof Tuberculosis Elimination (CDC; At-lanta, GA, USA; www.cdc.gov) said,

“We are encouraged that a quickeroption for detecting contagious TB isnow available to assist in determiningwhether patients must remain in iso-lation. The test may make it possiblefor some patients to be released fromhospital isolation sooner, freeing uplimited medical resources and remov-ing restrictions on patients’ move-ments and interactions. While thistest can assist health care providers inmaking important decisions regardingisolation, it does not replace the con-tinued need for culture testing to en-sure patients with TB are accuratelydiagnosed and treated.”

Test Helps Physicians Remove Suspected TB Patients from Isolation


Image: The Xpert MTB/RIFcartridge-based, fully auto-mated molecular diagnostictest for tuberculosis (Photocourtesy of Cepheid).

MOLECULAR DIAGNOSTICS SYSTEMBeckman Coulter

The DxN VERIS integrates sample introduction,NA extraction, reaction setup, RT PCR amplifica-tion/detection, and results interpretation into onesystem saving space, time and cost. The VERISoffers fast turnaround times, enhanced productiv-ity and flexibility, and results in just 70 minutes.

QUANTITATIVE HCV TESTCepheid

The Xpert HCV Viral Load test is designed for therapid measurement of Hepatitis C virus viral load,and confirmation of HCV infection. The test pro-vides reliable results in less than two hours, mak-ing it a valuable tool for clinicians in the manage-ment of HCV-infected patients on antiviral therapy.

HIV 1/2 ASSAYSChembio Diagnostic Systems

The HIV 1/2 STAT-PAK tests are easy-to-perform,single-use tests for the rapid detection of antibod-ies to HIV 1 and HIV 2 at the POC. The tests re-quire only a minimal sample volume, offer a longshelf life, provide results in 15 minutes, and are in-tended for use with serum, plasma, and blood.




NNewly generated data regarding the H1N1strain of swine flu that has killed more than

1,200 since December 2014 suggests that the virushas acquired mutations that make it more danger-ous than previously circulating strains of H1N1 in-fluenza.

Investigators at the Massachusetts Institute ofTechnology (Cambridge; www.mit.edu) comparedthe genetic sequences of two Indian swine flustrains that recently had been deposited into pub-licly available influenza databases to the strain ofH1N1 that emerged in 2009 and killed more than18,000 people worldwide between 2009 and2012.

They found that that the recent Indian strainscarried new mutations in the hemagglutinin protein(H1) that were known to be capable of increasingthe virulence of the virus. One of the new muta-tions was in amino acid position D225, which hadbeen linked with increased disease severity. Anoth-

er mutation, in the T200A position, allowedhemagglutinin to bind more strongly to glycan re-ceptors, making the virus more infectious.

These findings apparently contradict previous re-ports from Indian health officials that the strain hadnot diverged from the 2009 H1N1 version.

“We are really caught between a rock and a hardplace, with little information and a lot of misinfor-mation,” said senior author Dr. Ram Sasisekharan,professor of biological engineering at the Massachu-setts Institute of Technology. “When you do real-time surveillance, get organized, and deposit thesesequences, then you can come up with a betterstrategy to respond to the virus. The point we aretrying to make is that there is a real need for aggres-sive surveillance to ensure that the anxiety and hys-teria are brought down and people are able to focuson what they really need to worry about. We needto understand the pathology and the severity, ratherthan simply relying on anecdotal information. The

goal is to get a clearer picture of the strains that arecirculating and therefore anticipate the right kind ofa vaccine strategy for 2016.”

The report was published in the March 11,2015, issue of the journal Cell Host & Microbe.

Image: A colorized transmission electron micrograph(TEM) showing H1N1 influenza virus particles (Photocourtesy of MIT).

Recent Indian Swine Flu Isolates DisplayMutations For Increased Virulence

II n patients with chronic heart failure, the vita-min D metabolite 1,25-dihydroxyvitamin D

(1,25(OH)2D), also called calcitriol, and its ratioto parathyroid hormone (PTH 1-84) may help pre-dict cardiovascular death.

Heart failure, with high morbidity and mortality,is increasingly prevalent worldwide, and biomarkersmay help doctors predict heart failure and help pa-tients survive and patients with decreased calcitrioland decreased ratio of calcitriol to PTH might bene-fit from more aggressive supplementation.

Scientists at the Cliniques Universitaires Saint Luc(Brussels, Belgium; www.saintluc.be) investigated170 chronic heart failure patients. Overall, 36 pa-tients were female, 134 patients were male, and theaverage age was 67 years. Their overall mean ejec-tion fraction was 23%, and the origin of heart failurewas ischemic in 119 patients and dilated cardiomy-

opathy in 51 patients. The team examined the abili-ty of calcitriol and its ratio with PTH(1-84) to predictcardiovascular death in chronic heart failure, and de-termined the patients’ calcitriol and PTH(1-84) levelsat baseline. The 1,25(OH)2D was measured by a ful-ly automated LIAISON XL 1,25 Dihydroxyvitamin Dassay (DiaSorin; Saluggia, Italy; www.diasorin.com).

The investigators found that serum calcitriol lev-els decreased markedly according to heart failureseverity, and that decreased ratios of calcitriol toPTH(1-84) were significantly related to heart failureseverity. After eight years of follow-up, the calcitrioland the ratio of calcitriol to PTH(1-84) were strong-ly able to predict the deaths of 106 patients whodied from cardiovascular causes. In patients withheart failure, vitamin D deficiency and hyper-parathyroidism are common, and evidence is grow-ing for the role of vitamin D and PTH in worsening

heart failure.Damien Gruson, PhD, professor and associated

laboratory director in the Department of Laborato-ry Medicine and lead study author, said, “We weresurprised by the strong predictive power of1,25(OH)2D and its ratio to 1-84 PTH. It is note-worthy that in this study the 1,25(OH)2D wasmeasured by a novel extraction-free, fully automat-ed assay based on an unique murine monoclonalantibody, which recognizes the conformationalchange induced by the binding of the 1,25(OH)2Dto a recombinant fusion protein. Our results canprovide physicians with a new tool – the1,25(OH)2D to PTH ratio – to risk stratify heartfailure patients.” The study was presented at theannual meeting of the Endocrine Society, ENDO2015 held March 5-8, 2015, in San Diego (CA,USA; www.endocrine.org).

Monitoring Calcitriol May Help Prevent Chronic Heart Failure Death

HEMATOLOGY ANALYZERDirui Industrial

The BCC-3600 offers a user-friendly design,along with easy operation and maintenance. Theanalyzer features perfect QC function, 21 param-eters and RBC, WBC, and PLT histograms, accu-rate and reliable results, and a large storage ca-pacity for 10,000 results.

DIFFERENTIAL ANALYZEREdan Instruments

The DS-500i five-part automated analyzer fea-tures a dual operating system, color LCD screenfor status monitoring, and economical test run-ning. The system also offers a high-capacity auto-matic sample conveyer, and a sample browser forauto-conveyer and batch verification.

DIABETIC BIOMARKER TESTEKF Diagnostics

The Stanbio Chemistry GSP LiquiColor assayprovides a 2-3 week indicator of average bloodglucose. The GSP serves as an accurate interme-diate marker of glycemia in instances whereHbA1c may be of limited value such as pregnan-cy, reduced RBC lifespan, and hemodialysis.




AAmultianalyte algorithmic immunohistochem-istry (IHC) assay accurately identifies patients

with locoregional esophageal adenocarcinoma (EC)who exhibit extreme resistance to neoadjuvantchemoradiotherapy.

The test analyzes the localization of three pro-tein biomarkers within a patient’s tumor to classifythe cancer as either responsive to or resistant topresurgical chemoradiotherapy and demonstratesstrong accuracy and specificity in identifying pa-tients with tumors that are unlikely to respond tostandard presurgical (neoadjuvant) chemotherapyand radiation.

Scientists at Baylor College of Medicine(Houston TX, USA; www.bcm.edu) and their col-

leagues studied archived biopsy specimens of ECwhich were subject to IHC examination of com-partmentalized immunoreactivity of nuclear fac-tor kappa B (NF-κB), Sonic Hedgehog (SHH), andGLI family zinc finger 1 (Gli-1), and a labeling in-dex score was assigned to each biomarker. Pre-treatment tumor biopsies were used to evaluateresistance (exCTRT) or responsiveness to (non-exCTRT) standard presurgical chemoradiothera-py (CTRT) regimens under accredited certifiedlaboratory protocols.

According to validation studies, the Deci-sionDx-EC test (Castle Biosciences, Inc.;Friendswood, TX, USA; www.castlebiosciences.com) can reliably differentiate patients who are

complete or partial responders to chemoradio-therapy from those who are non-responders. Aninitial, single center clinical validation study of167 patients, which was used as training set forthe current validation study, achieved an area un-der the curve (AUC) of 0.96 and an overall accu-racy of 90%. The second validation, enrolled 64patients from two independent institutions, andachieved an AUC of 0.96 and an overall accuracyof 84% for classifying which patients are likely tobe highly resistant to presurgical chemotherapytreatment for esophageal cancer.

The study was published on February 19, 2015,in the journal Gastrointestinal Cancer: Targets andTherapy.

Multianalyte Test Predicts Drug Resistance in Esophageal Cancer

TT raditional fecal-based methods have poor sensi-tivity for the detection of Strongyloides sterco-

ralis, therefore are inadequate for post-treatmentevaluation of infected patients who should be care-fully monitored to exclude the persistence of the in-fection.

The performance of the five serological tests hasbeen compared for the follow up of patients aftertreatment, who were infected with S. stercoralis orthreadworm, in order to identify if antibody declinecould be used a surrogate marker for cure, in addi-tion to negative stools.

Scientists at the Center for Tropical Diseases,Sacro Cuore Hospital (CTD; Verona, Italy; www.sacrocuore.it) and an international team carried outretrospective study on archived, anonymized seraavailable at the CTD. Samples were classified accord-ing to a composite reference standard, a procedureused for evaluation of diagnostic tests when there isno gold standard: a) positive: positive fecal testsand/or at least 3/5 positive serologic tests; b) nega-tive: negative fecal tests and less than three positiveresults out of the five serologic tests.

The samples were tested with two commercially-

available enzyme-linked immunosorbent assays(ELISA) for Strongyloides (IVD Research; Carlsbad,CA, USA; www.ivdresearch.com; and Bordier Affin-ity Products; Crissier, Switzerland; www.bordier.ch), and three noncommercial tests: immunofluo-rescence antibody test (IFAT), recombinant Strongy-loides antigen (NIE) enzyme-linked immunosorbentassay (NIE-ELISA), and the NIE- luciferase immuno-precipitation systems (NIE-LIPS).

A high proportion of samples demonstrated foreach test a seroreversion or a relevant decline in op-tical density/relative light units halved or decreasesof at least two titers for IFAT at follow up. The re-sults confirmed by the linear mixed effects modelthat showed a trend to seroreversion over time forall tests. In particular, IVD-ELISA where almost 90%samples demonstrated relevant decline and almost87% of IFAT had the best performances. Consideringonly samples with a complete negativization, NIE-ELISA showed the best performance with 72.5%seroreversion.

The authors that concluded that each of theserology tests considered can be used for monitor-ing patients who received a treatment for S. sterco-

ralis infection. Serology, in combination with fecal-based methods, should be used as the preferred toolfor the follow up. Validation of polymerase chain re-action (PCR) techniques for the follow up might bea useful support for situations of uncertainty such aspatients with serology values that do not seem todecrease over time. The study was published onFebruary 10, 2015, in the journal Public Library ofScience Neglected Tropical Diseases.

Image: Adult female of Strongyloides stercoralis col-lected in bronchial fluid of a patient with disseminateddisease (Photo courtesy of Sacro Cuore Hospital).

Five Serologic Tests Evaluated for Threadworm Infection Follow-Up

LAB SOFTWAREELITech Group Solutions

The Selectra Touch Pro software is designed tohave intuitive ease of use across a wide range oflab settings, from labs with basic IT to those withfully automated informatics. Key features includetouch screen operation with to enhance productiv-ity and reduce errors.

CONICAL TUBESEppendorf

The conical tubes feature enhanced specificationsto make them ideally suited for cell biology appli-cations, as well as for sample preparation proto-cols in microbiology and molecular biology labs.The tubes are available in 15 mL and 50 mL, andmeet the demands of diverse lab applications.

CLINICAL CHEMISTRY SYSTEMErba Diagnostics Mannheim

The XL 640 is an economical system designed toensure a high degree of precision with diffractiongrating. The system is easy to operate, offers anextensive QC program, 56 on-board reagent posi-tions, clot detection, and a throughput of 640 testsper hour with ISE.


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AAnew medical device, which combines nanotech-nology with a pregnancy tester, could help diag-

nose and treat the one million people in the UK whodon’t know they have kidney disease.

Every day 19 people in the UK are diagnosed withkidney failure yet there is currently no device that canbe used by doctors for day-to-day monitoring of kid-ney disease and four of the 19 people will not havevisited specialist services for sufficient time to preparefor their treatment.

The apparatus is a quantitative electrochemical lat-eral flow assay (QELFA) and uses nanoparticles to testthe patient’s urine giving results in seconds. It islinked via mobile technology so doctors can trackhow the disease is developing. The devise was devel-oped by engineers and costs about GBP 10 can beused at home and could revolutionize kidney diseasecare in the UK, which currently costs the UK Nation-al Health Service (NHS) over GBP 1.4 billion, morethan breast, lung, colon and skin cancer combined.

The device, which works like a pregnancytest, was created by Bio Nano Consulting(London, UK; www.bio-nano-consulting.com).The digital readout of the test enables the au-tomatic and accurate collation of kidney-func-tion readings into a central database using mo-bile technology. Behind the patients who de-velop kidney failure and in need of rapid diag-nosis are many more who will have a lesser de-gree of kidney dysfunction, called Chronic Kid-ney Disease (CKD), that will place them at in-creased risk of cardiovascular disease andacute kidney injury.

Helen Meese CEng, MIMech, PhD, Head of Ma-terials at the Institution of Mechanical Engineers(London, UK; www.imeche.org), said, “The QELFAdevice is a brilliant example of what’s possible. Usingan old technology like a pregnancy tester and combin-ing it with nanotechnology, you have a device whichcould not only diagnose the million people in the UK

who are unaware they have kidney disease, but alsohelp doctors effectively monitor those undergoingtreatment.”

Image: The quantitative electrochemical lateral flow as-say (QELFA) device combines nanotechnology and apregnancy tester, and is designed to help treat kidneydisease (Photo courtesy of Bio Nano Consulting).

Medical Device Combines Nanotechnology to Diagnose Kidney Disease

Age of Transfused Blood inCritically Ill Adults Assessed

BB lood for transfusion that has been stored for threeweeks appears to be just as good as fresh blood for

critically ill patients in need of red blood cell transfu-sion. Current regulations permit the storage of red cellsfor up to 42 days, but prolonged storage has been asso-ciated with changes that may render red cells ineffec-tive as oxygen carriers and that lead to the accumula-tion of substances that have untoward biologic effects.

An international team of scientists led by those atSainte-Justine University Hospital (Montreal, QC,Canada; www.chusj.org) enrolled critically ill adultsfrom tertiary care intensive care units (ICUs) at 64 cen-ters; 26 in Canada, 20 in the United Kingdom, 10 inFrance, 7 in the Netherlands, and 1 in Belgium. Be-tween March 2009 and May 2014, at the various cen-ters, 1,211 patients were assigned to receive fresh redcells (fresh-blood group) and 1,219 patients were as-signed to receive standard-issue red cells.

Red cells were stored a mean (± standard deviation)of 6.1 ± 4.9 days in the fresh-blood group as comparedwith 22.0 ± 8.4 days in the standard-blood group. At90 days, 448 patients (37.0%) in the fresh-blood groupand 430 patients (35.3%) in the standard-blood grouphad died. There were no significant between-group dif-ferences in any of the secondary outcomes such as ma-jor illnesses; duration of respiratory, hemodynamic, orrenal support; length of stay in the hospital; and trans-fusion reactions or in the subgroup analyses.

The authors concluded that transfusion of fresh redcells, as compared with standard-issue red cells, did notdecrease the 90-day mortality among critically illadults. Blood transfusions save lives, but there is noneed to worry about the safety of the age of blood rou-tinely used in hospitals. Alan Tinmouth, MD, a physi-cian and scientist and a coauthor of the study said,“Previous observational and laboratory studies havesuggested that fresh blood may be better because of thebreakdown of red blood cells and accumulation of tox-ins during storage. But this definitive clinical trial clear-ly shows that these changes do not affect the quality ofblood.” The study was published on March 17, 2015,in the New England Journal of Medicine.

Visit us at:Stand: C033




FFecal immunochemical testing(FIT) is a more advanced method

than the traditional three-samplestool test, guaiac-based fecal occultblood tests (gFOBTs).

Fecal immunochemical testing re-quires just a single stool sample tocheck for the presence of blood, apossible indicator of adenomas or col-orectal cancer (CRC) and with aneasy collection device, it has beenfound to increase participation up-take.

In support of Colorectal CancerAwareness Month (March), UnitedEuropean Gastroenterology (UEG; Vi-

enna, Austria; www.ueg.eu) calls up-on all European Union (EU) countriesto evaluate advanced screening tech-niques, such as a simple fecal im-munological test, to help increase up-take and survival rates. FIT offers sub-stantial clinical benefits due to its su-perior analytical technique. ThegFOBT method relies on simple oxi-dation, which can be adversely affect-ed by the influence of dietary hemo-globin. However, the FIT technique,such as the OC FIT-CHEK (Polymed-co Inc.; Cortlandt Manor, NY, USA;www.polymedco.com) is more sensi-tive. Specific analysis for hemoglobin

detects smaller levels of bleeding andtherefore, more early cancers as wellas more adenomas. The number offalse positives is also reduced as thereis unlikely to be significant interfer-ence from dietary hemoglobin foundin feces. If an adverse result is detect-ed, patients are then referred for acolonoscopy.

Rates for colorectal cancer screen-ing programs vary from as little as15% in areas of Poland and just 22%in Belgium to a healthier rate of 64%in Norway and 70% in Finland. How-ever, uptake generally throughout Eu-rope remains alarmingly low, withthe percentage of eligible adultsscreened in many countries fallingway short of the 65% rate considereddesirable by the European Commis-sion and already achieved in theUSA. Colorectal cancer is treatable

when detected early, yet it is estimat-ed to claim the lives of over 500 Eu-ropeans every day.

Monique E. van Leerdam, MD, agastroenterologist from the Nether-lands Cancer Institute (Amsterdam,The Netherlands; www.avl.nl) said,“FIT’s simple collection system andenhanced sensitivity offers an attrac-tive alternative to existing gFOBTstool tests as a first-line screening pro-cedure. It will also make it easier forEuropeans at risk to get screened andensure colorectal cancer gets detect-ed as early as possible, enabling thou-sands to receive successful treat-ment.”

Image: The OC-Sensor Diana, a highthroughput automated analyzer usedfor the detection of colorectal cancer byOC FIT-CHEK fecal immunochemicaltesting (Photo courtesy of Polymedco).

Advanced Screening Test Improves Colorectal Cancer Survival Rates


PIPETTE ADAPTORIntegra Biosciences

The VIAFLO ASSIST is designed to work with theVIAFLO II electronic pipette to obtain pipettingprotocols and execute the desired application.Working together, the two devices help preventusers from RSI, and help increase the repro-ducibility of prolonged pipetting protocols.

ELISA ANALYZERMaroche

The ATOM Plus fully automated, open system fea-tures a small design, new temperature checkingsystem, and washing/reading system. The unitcan run up to 16 samples together, 8 compatibleELISA tests, and provides allergology IgE deter-mination.

AUTOMATED TEST SYSTEMNanoEnTek

The FREND system offers simple three-step oper-ation, with no need to batch any samples. The ac-curate system offers fast quantitative immunoas-say results, electronic code chip calibration, anddaily electronic system QC control that takes lessthan two minutes.


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AAppendicitis is the most common abdominal sur-gical emergency in the pediatric population, yet

the diagnosis remains challenging in many cases andthe use of laboratory data as a diagnostic adjunct hassimilarly been associated with relatively low sensitiv-ity, and children with pathology-proven appendicitiscan often present with a normal leukocyte count.Two standard diagnostic tests commonly obtained inchildren evaluated for abdominal pain – when com-bined can improve the ability of emergency depart-ment physicians and pediatric surgeons to identifythose patients who should be sent to the operatingroom for prompt removal of an inflamed appendixand those who may be admitted for observation, andthose who may safely be discharged home.

Medical staff at the Boston Children’s Hospital

(Boston, MA, USA; www.childrenshospital.org)conducted a retrospective cohort study of 845 pa-tients, three to 18 years of age, who were evaluat-ed in an emergency department with a chief symp-tom of abdominal pain between January 1, 2010and December 31, 2012. Negative (NPV) and pos-itive predictive values (PPV) for appendicitis werecalculated for common constellations of US findingsand compared with and without the use of labora-tory thresholds: white blood cell count (WBC) >9× 103/mL and polymorphonuclear leukocyte differ-ential (PMN%) >65% for PPV; WBC <9 × 103/mLand PMN% <65% for NPV. Ultrasound reportswere reviewed using standardized definitions andcase report forms.

Of the 845 children in the study, 393 (46.5%)

had appendicitis. An elevated WBC count wasfound in 348 (62.1%) of these patients, and aPMN% shift was found in 340 (58.5%). In childrenwho did not have appendicitis, the WBC was ele-vated in 212 (37.9%), and the PMN% shift oc-curred in 241 (41.5%). The ability to identify chil-dren with and without appendicitis was significant-ly improved when sonography and laboratory find-ings were paired. The risk of appendicitis rose from79.1% to 91.3% when laboratory studies indicateda bacterial infection and sonography showed pri-mary signs of appendicitis, such as increased bloodflow or a thickening in the wall of the appendix.

The study was published online on January 30,2015, in the Journal of the American College ofSurgeons.

Blood Tests Help Identify Children Who Need Appendectomy

CChanges in the epidemiology of Clostridium dif-ficile infections have occurred since the emer-

gence of the North American pulsed-field gel elec-trophoresis type 1 (NAP1) strain, which has beenresponsible for geographically dispersed hospital-as-sociated outbreaks. Clostridium difficile is a bacteri-um that causes colitis and inflammation of thecolon and infection can occur through touchingsurfaces or items that are contaminated with feces,in which the bacteria are is shed. People who aretaking antibiotics for other illnesses are most proneto C. difficile infection as antibiotics can destroysome of the friendly bacteria in the gut, meaning itmay be less protected against C. difficile.

A team of investigators led by those at the Cen-ters for Disease Control and Prevention (CDC; At-lanta, GA, USA; www.cdc.gov) identified all posi-tive C. difficile test results from 88 inpatient and 33outpatient laboratories serving residents in surveil-lance areas in 2011. A case of C. difficile infection

was defined as a positive result on a C. difficile tox-in or molecular assay of a stool specimen obtainedfrom a surveillance-area resident at least one year ofage who had not had a positive assay in the previ-ous eight weeks. Recovered isolates underwentpulsed-field gel electrophoresis (PFGE) and also un-derwent polymerase-chain-reaction (PCR) assay todetect the presence of particular genes.

The CDC say these results indicate that im-proved antibiotic use and infection control needs tobe put in place for outpatient health care, as well asinpatient facilities. Michael Bell, MD, deputy direc-tor of the Division of Healthcare Quality and Promo-tion at the CDC, said, “Overall, there are two mainthings that need to be improved. Number one ishow antibiotics are being used, making sure that weuse them when they’re truly necessary and only foras long as necessary. The second element is to en-sure rigorous infection control in all health care set-tings. C. difficile infections must be diagnosed

quickly and correctly so that the infected patient canbe cared for using the right infection control tech-niques.” The study was published on February 26,2015, in the New England Journal of Medicine.

Image: The ultrastructural morphology exhibited by asingle Gram-positive Clostridium difficile bacillus (Pho-to courtesy of Melissa Brower / CDC).

Increased Clostridium Difficile Infections Due to Antibiotic Misuse



AA study involving 10 American travelers whocontracted Chikungunya virus (CHIKV) in-

fection in Haiti has highlighted the similarities be-tween this viral infection and rheumatoid arthritisand emphasized the difficulty faced by diagnosti-cians. Chikungunya virus is an Alphavirus with apositive-sense single-stranded RNA genome ofabout 11.6 kilobases. It is a member of the Semli-ki Forest virus complex and is closely related tothe viruses that cause eastern equine encephalitisand western equine encephalitis. In the UnitedStates, it is classified as a category C prioritypathogen and work with the virus re-quires biosafety level III precautions.Human epithelial and endothelial cells,primary fibroblasts, and monocyte-de-rived macrophages are permissive forCHIKV in vitro, and viral replication ishighly cytopathic, but susceptible totype-I and -II interferon. In vivo, CHIKVappears to replicate in fibroblasts, skele-tal muscle progenitor cells, and my-ofibers. CHIKV infection causes a fever,rash, and severe joint pain in the hands,feet, knees, neck, and elbows. The feverand rash typically subside in seven to 10days, but symptoms of arthritis may per-sist for 12-15 months in up to 60% ofpatients. Some patients’ symptoms maypersist for three years or more.

As little is known about the rheuma-tologic and immunologic features ofCHIKV arthritis in humans, particularlyas compared to rheumatoid arthritis(RA), investigators at Washington Uni-versity School of Medicine (St. Louis,MO, USA; www.wustl.edu) compareddiagnostic features of CHIKV infectionto those of RA. To this end they used ad-vanced cell biology instruments to ana-lyze blood samples from 10 individualswho became infected with CHIKV inHaiti in June 2014 and from RA patientsand healthy controls.

The most important diagnostic toolused in the study was the Fluidigm (SanFrancisco, CA, USA; www.fluidigm.com)CyTOF2 Mass Cytometer. This instru-ment enables simultaneous detection ofmany proteins in single-cell biology andboosts understanding of both cell typeand function at the single-cell level. Us-ing stable metal isotopes and time-of-flight mass cytometry, the CyTOF2 pro-vides more than 120 detection channelsfor analysis of blood cell components.The investigators used the CyTOF2 toanalyze peripheral blood mononuclearcells in CHIKV-infected patients, healthycontrols, and patients with untreated, ac-tive RA. All patients with CHIKV arthritishad detectable anti-CHIKV IgG. Amongthe ten CHIKV-infected individuals, eightdeveloped persistent symmetric pol-yarthritis, and otherwise met the 2010

American College of Rheumatology (ACR)/Euro-pean League Against Rheumatism (EULAR) criteriafor (seronegative) RA. CyTOF analysis revealed thatRA and CHIKV-infected patients had greater percent-ages of activated and effector CD4+ and CD8+ T-cells than healthy controls.

The investigators have established an onlineregistry at http://chikv.dom.wustl.edu to build adatabase for studying the virus in more detail.

The CHIKV-arthritis study was published in theJanuary 20, 2015, online edition of the journalArthritis and Rheumatology.

Image: Cryoelectron microscopy reconstruction ofChikungunya virus (Photo courtesy of Wikipedia).

Difficulties in Distinguishing Chikungunya Virus Infection from Rheumatoid Arthritis


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AAnovel approach for diagnosing liver cancer (he-patocellular carcinoma) is based on analytical

methods frequently used in the earth sciences.Hepatocellular carcinoma (HCC) is the most

common type of liver cancer. Most cases of HCCare secondary to either a viral hepatitis infection(hepatitis B or C) or cirrhosis (alcoholism being themost common cause). Compared to other cancers,HCC is a rare tumor in the United States. In coun-tries where hepatitis is not endemic, most malig-nant cancers in the liver are not primary HCC butmetastasis of cancer from elsewhere in the body.

Investigators at the École Normale Supérieurede Lyon (France; www.ens-lyon.fr) analyzed the ra-tios of stable copper (Cu) and sulfur (S) isotopes inliver cancer patients. This study was a hi-tech lookinto observations dating from as far back as 1928indicating that the hypoxic tumor environment al-tered the normal metabolism of elements such as

copper and sulfur as well as the redox state of themetals, impacting their ability to bind to ligands.

Specifically, the investigators used the stable iso-tope compositions of copper (65Cu/63Cu) and sulfur(34S/32S) in the blood of patients with (HCC) as atool to explore cancer-driven copper and sulfur im-balances.

They reported that copper was 63Cu-enriched byabout 0.4% and sulfur was 32S-enriched by about1.5% in the blood of patients compared with that ofcontrol subjects. HCC patients had more copper inred blood cells and serum compared with controlsubjects. However, the isotopic signature of thisblood extra copper burden was not in favor of a di-etary origin but rather suggested a reallocation inthe body of copper bound to cysteine-rich proteinssuch as metallothioneins. The magnitude of the sul-fur isotope effect was similar in red blood cells andserum of HCC patients, implying that sulfur frac-

tionation was systemic. The 32S-enrichment of sul-fur in the blood of HCC patients was compatiblewith the notion that sulfur partly originated fromtumor-derived sulfides.

The study was published in the January 27,2015, issue of the journal Proceedings of the Na-tional Academy of Sciences of the United States ofAmerica (PNAS).

Image: A micrograph of a hepatocellular carcinomataken from a liver biopsy, and colored with trichromestain (Photo courtesy of Wikimedia Commons).

Analysis of Isotope Imbalance May Aid Liver Cancer Diagnosis

UUS Food and Drug Administration (FDA) emer-gency-use-authorization (EUA) allows the test to

be used worldwide for the presumptive detection ofZaire ebolavirus (detected in the West Africa outbreakin 2014) in individuals with signs and symptoms ofinfection in conjunction with epidemiological risk fac-tors, including geographic locations with high preva-lence of infection. Ebola and other viral hemorrhagicfevers are difficult to discriminate because many ofthe early signs and symptoms are nonspecific andcommon to other infectious diseases such as Denguefever, Lassa fever, typhoid, and malaria.

Corgenix Medical Corporation (Broomfield, CO,USA; www.corgenix.com) received the EUA for itsReEBOV Antigen Rapid Test, the first rapid diagnos-tic test (RDT) and the first immunoassay with FDAEUA for the presumptive detection of Ebolavirus.The US regulatory authorization follows the WorldHealth Organization (WHO)’s recent emergency-use listing of this test, making it available world-

wide. The EUA allows for its use in circumstanceswhen use of an Ebola RDT is determined more ap-propriate than use of an authorized Ebola nucleicacid (molecular) test, which has been demonstratedto be more sensitive in detecting the Zaireebolavirus. Molecular testing in West Africa canstill take days to return results from central testinglaboratories, whereas ReEBOV is for rapidly diag-nosing suspected Ebola cases at point-of-care in anyclinical facility or field laboratory capable of suchtesting. ReEBOV is currently not authorized forEbolavirus infection screening such as airportscreening or contact tracing.

“The FDA and WHO have been working closelywith us throughout this process to get this new test inthe hands of those battling on the front lines of theEbola outbreak as quickly as possible,” said DouglassSimpson, Corgenix president and CEO, “Completingthis product development in less than a year demon-strates how governmental agencies, regulatory bod-

ies, industry, non-profits and others can work togeth-er to find solutions to catastrophic events such as theEbolavirus outbreak. This collaboration has enabledus to quickly deliver this critically important point-of-care test and potential breakthrough in the fightagainst Ebola in the current outbreak in West Africa.”

The ReEBOV test was developed by Corgenix incooperation with additional members of the Viral He-morrhagic Fever Consortium (VHFC) and other col-laborators in West Africa. Mr. Simpson noted, “We arepleased to be part of the VHFC. This is a remarkablegroup of scientists who have been in the forefront ofresearch in Ebola, Lassa fever, and other dangerous vi-ral diseases in Africa for many years. A key componentof our success is a result of the commitment and par-ticipation of the Ministry of Sanitation and PublicHealth of the Republic of Sierra Leone and the dedicat-ed medical personnel of the Kenema GovernmentHospital in Kenema, Sierra Leone, a number of whomhave died fighting the current Ebola outbreak.”

Rapid Ebola Test Receives FDA Authorization and WHO Listing for Emergency Use

DIAGNOSTIC SYSTEMNanoString Technologies

The nCounter Dx analysis system is available intwo configurations: one for in vitro diagnostics andone for life science research. Both options offerease of use, digital detection, ready-to-usereagents, touch screen user interface, and highquality date with rapid results.

MULTI-PANEL CUPNoble Medical

The Insta-Screen features a tamper-evident de-sign, and easy-to-interpret color bands for readingresults. The multi-panel cup also offers a built-intest control, options for 14 available CLIA waiveddrugs, and an 18-month shelf life.

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The SensAheart cardiac FABP test is designed forthe fast and reliable detection of FABP3 antigenfrom either capillary whole blood or venous wholeblood/plasma/serum samples. The test is intend-ed for miniature-sized samples, and offers easyuse and enhanced performance.



CComplete blood counts (CBC) includingwhite blood cell count (WBC) differentials

and C-reactive protein (CRP) have been fre-quently utilized as the biomarkers for inflam-matory diseases such as bacterial infection.

An automated hematology analyzer hasbeen developed which can simultaneouslymeasure CBC including three-part WBC differ-ential (3-Diff) and CRP using ethylenedi-aminetetraacetic acid dipotassium salt dihy-drate (EDTA-2K) anticoagulated whole bloodwithout centrifugation for serum preparation.

Scientists at HORIBA Medical (Ky-oto, Japan; www.horiba.com) used thecompany’s automated hematology ana-lyzer, The Microsemi CRP, which isequipped with the electrical resistancemethod for CBC with 3-Diff of granulo-cytes (GRA) including neutrophilseosinophils and basophils, lymphocytes(LYM), and monocytes (MON). CRP ismeasured with the latex immune tur-bidimetry method following theprompt hemolyzation of EDTA-2K anti-coagulated whole blood. The obtainedvalue is then converted into plasmaconcentration according to hematocrit(HCT %) of respective sample to finallyprovide as “whole blood CRP.”

Correlation tests for the MicrosemiCRP were compared with those of Mi-cros CRP200, a preceding Horiba Med-ical model, and also those of the ADVIA2120i (Siemens Healthcare Diag-nostics; Tarrytown, NY, USA; www.healthcare.siemens.com) routine hema-tology analyzer. The results of freshwhole blood and serum CRP obtainedusing Micros CRP200 were comparedwith those of serum CRP obtained us-ing HITACHI 7600 routine analyzer(Tokyo, Japan; www.hitachi-hitec.com).

The CBC data examined using Mi-crosemi CRP showed excellent correla-tion with the previous model, MicrosCRP200and also those obtained usingthe routine analyzer, ADVIA 2120i. Inregards to the 3-Diff, both GRA (%) andLYM (%) showed the excellent correla-tion coefficient between MicrosemiCRP and Micros CRP200 as well asADVIA 2120i. (MON (%) showed goodcorrelation between Microsemi CRPand Micros CRP200, but lower correla-tion between Microsemi CRP and AD-VIA 2120. CRP data showed the goodcorrelation with HITACHI 7600 andMicros CRP200.

The authors concluded that Microse-mi CRP was a convenient laboratory an-alyzer, which could provide the clinical-ly reliable data about CBC including 3-Diff and CRP using only 18 L wholeblood within approximately four min-utes. Therefore, Microsemi CRP seemed

suitable in the setting of point of care testing(POCT) for the patients with inflammatory dis-eases such as bacterial infection, especially forpediatric ones in whom sufficient volume ofsamples necessary to simultaneous measure-ment of CBC including WBC Diff and CRP usingthe routine analyzers. The study was first pub-lished online on December 11, 2014, in the In-ternational Journal of Laboratory Hematology.

Image: The Microsemi CRP automated hematol-ogy analyzer (Photo courtesy of HORIBA Med-ical).

Microsemi CRP Automated Hematology Analyzer Evaluated


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AA new test has been developed that can pre-dict the survival chances of women with

breast cancer by analyzing images of hotspotswhere there has been an intense immune reac-tion to a tumor.

The test that combines automated histologicalimage processing with methods of spatial statisticscould assess whether a woman’s immune system isholding a cancer at bay and pick out those who willneed intensive treatment to combat their more ag-gressive disease.

Scientists at The Institute of Cancer Research(London, UK; www.icr.ac.uk) and their colleaguesanalyzed tumor samples from 245 women with atype of breast cancer called estrogen receptor nega-tive (ER negative), which is particularly hard totreat. The team split women with breast cancer in-to two groups based on the numbers of immunehotspots spots within their tumors.

The tumor sections were scanned usingScanScope TX Scanner (Aperio Technologies; Vista,CA, USA; www.leica-microsystems.com) with × 20magnification and digitized for image analysis.Stained frozen tumor section images for 245 ER-negative breast cancer patients were analyzed usingtheir automated cell classification pipeline CRIm-age. The cell classification and location data wereused as input for Getis–Ord hotspot analysis to en-able the automated detection of statistically signifi-cant spatial clusters.

The scientists found that images of hotspotswhere immune cells were spatially clustered to-gether around breast cancer cells provided a bettermeasure of immune response than simply the num-bers of immune cells within a tumor. Womenwhose cancers had a high number of spots lived anaverage of 91 months before their cancer spread,compared with just 64 months for those with a low

number of spots. The test is the first objectivemethod of measuring the strength of a patient’s im-mune response to their tumors. Its automatedanalysis could complement existing methods wherepathologists examine tumor samples under the mi-croscope to gain a sense of whether there is a strongimmune response.

Yinyin Yuan, PhD, the team leader and seniorauthor, said, “We have shown that to measure thestrength of an immune response to a cancer, weneed to assess not just how many immune cellsthere are, but whether these are clustered togeth-er into cancer-busting hotspots. By analyzing thecomplex ways in which the immune system inter-acts with cancer cells, we can split women withbreast cancer into two groups, who might needdifferent types of treatment.” The study was pub-lished on February 27, 2015, in the journal Mod-ern Pathology.

Breast Cancer Test Links Immune Hotspots to Better Survival

FF indings from an independent re-view of studies suggests that cur-

rently available point-of-care (POC)tests are significantly less reliablethan conventional microscopy, em-phasizing the need for developmentof better and affordable POC diag-nostics for schistosomiasis (bil-harzia), classified as a neglected trop-ical diseases (NTD).

Simpler, more rapid POC testswith sufficient accuracy could replacemicroscopy for diagnosing schistoso-miasis. The review was conducted byresearchers from the Cochrane Infec-tious Diseases Group hosted at theLiverpool School of Tropical Medicine(LSTM; Liverpool, UK; www.lstmliverpool.ac.uk) to estimate accuracyof the circulating antigen (CA) test forurinary schistosomiasis and intestinalschistosomiasis, and of urine reagent(URStrip) tests for urinary schistoso-miasis.

Two independent authors identi-fied and assessed 90 studies involvingalmost 200,000 people, with 88 ofthe studies from field settings inAfrica. Studies compared POC tests tomicroscopy as reference standard: forSchistosoma haematobium – mi-croscopy of urine prepared by filtra-tion, centrifugation, or sedimentation;for S. mansoni – microscopy of stoolby Kato-Katz thick smear.

Among the URStrip tests for uri-nary schistosomiasis, those for de-tecting blood (microhaematuria)were more accurate than those fordetecting protein (proteinuria) orwhite cells (leukocyturia). Sensitivityand specificity estimates: for blood75% and 87%; for protein 61% and82%; for white cells 58% and 61%,

respectively.For urinary schistosomiasis, CA

test performance was worse (39%sensitivity, 78% specificity) thanURStrips for blood. For intestinalschistosomiasis, CA test detectedmany infections identified by mi-croscopy but wrongly labeled manyuninfected people as infected (89%sensitivity, 55% specificity).

“The simple test using a strip fortesting blood in the urine workedwell. The antigen tests for the diseasedid not work so well for urinary schis-tosomiasis, and in intestinal schistoso-miasis it may classify many uninfectedpeople as infected and lead to unnec-essary treatment,” said lead authorDr. Eleanor Ochodo, StellenboschUniversity.

LSTM’s Prof. Russell Stothard, in-ternational expert in schistosomiasisand director of the new COUNT-DOWN research consortium, whichwill trial and evaluate new approach-es to drug distribution in NTD pro-gram, said: “Those in the field of NTDresearch and control welcome re-views of this kind, looking at the effi-cacy of diagnostic tests for diseases af-fecting some of the poorest communi-ties in the world. They draw togetherlargely fragmented literature into oneplace, allowing quick appraisal for in-formed decision-making. Reviewssuch as this will ensure that COUNT-DOWN benefits from the best re-search intelligence from within theNTD community and stays well in-formed throughout.”

The review, by Ochodo EA et al.,was published online March 11,2015, in Cochrane Database of Sys-tematic Reviews.

Effectiveness of Point-of-Care Diagnosticsfor Schistosomiasis Reviewed

Research in common parlance refersto a search for knowledge. One can

also define research as a scientific andsystematic search for pertinent informa-tion on a specific topic. Thus, the pur-pose of research is to discover answersto questions through the application ofscientific procedures.

IFCC-Task Force Young Scientists(IFCC-TF YS) in collaboration with As-sociation of Clinical Biochemists of India(ACBI) conducted a 5th Symposium onDecember 11, 2014, for young col-leagues in laboratory medicine. Theprogram was well attended by morethan 100 participants from India andabroad, including senior members fromthe IFCC, APFCB & ACBI. The eventwas hosted by organizing committeeACBI Conference (ACBICON) 2014 andDr. Praveen Sharma (Organizing Secre-tary). The event was organized at the AllIndia Institute of Medical Sciences (AI-IMS), Jodhpur (India).

This workshop covered the researchprocess, an overview of qualitative andquantitative methods, data collection,recording and analysis and final outputof a research proposal. It helped stu-dents to understand the basics of re-search process including the identifica-tion of a topic, preparation of a researchproposal and final research report, as-sessment criteria for this and associatedtimelines. The concept of these activitiesis to encourage interactions and net-working between young scientists alongwith education in the field of laboratorymedicine and research. In India, with thecollaborative efforts of ACBI and IFCC,the IFCC-TFYS has organized educa-tional workshops and symposia everyyear in the National Conference, i.e.,2010, 2011, 2011, 2013 & 2014.

Addressing the conclave, Dr. GrahamBeastall (President-IFCC) praised theTask Force initiatives and stressed uponthe need to share experiences andstrong networking activities. Dr. Jaya-shree Bhattacharjee (President ACBI)gave a welcoming addresses and sum-marized the ACBI initiatives for the youngbiochemists. Dr. Pradeep Kumar Dabla(Convener and Chair IFCC-TFYS) sum-marized the Task Force objectives, mem-bers & activities conducted. He assuredthe commitment of focused training andeducation to strengthen the future

IFCC Leaders Attend YoungScientistsSymposium atJodhpur, India


Edited by Tahir Pillay MBChB, PhD, FRCPath(Lon), FCPath(SA)IFCC members may send news to: Tahir Pillay MBChB, PhD, Head, Dept of Chemical Pathology, Faculty of Health Sciences, University of Pretoria, Private Bag Bag x323, Arcadia, 0007, South AfricaTel: (27) 12 319-2116; Fax: (27) 328 6000; Email: [email protected] NEWS

43

Cont’d on page 44


Photo: Participants at the ACBICON-2014 symposium including IFCC Presi-dent, Dr. Graham Beastall and IFCCPresident-elect, Dr. Maurizio Ferrari

The IFCC Beginner’s Course in Molecular Diagnos-tics is an initiative that is offered by the IFCC Clin-

ical Molecular Biology Curriculum (C-CMBC) to all na-tional societies1. This intense 6 day course teachesfrom the very basics to advanced molecular biologyand is based on the idea that everything needed toperform basic Molecular Biology can fit into a suitcaseand therefore would make it fairly inexpensive to per-form Molecular Diagnostics all over the world. Withthe recent introduction of the IFCC junior member ini-tiative, it also provides an opportunity for one memberfrom each country visited to travel to the next, andhelp out in the practical sessions, network and gainsome invaluable experience. In this way this coursebrings people from different countries together allow-ing them to experience each other’s customs, makefriends and network.

Preparation for this year’s 6th Molecular Biologycourse started in May 2014, with announcements be-ing sent to representatives of all IFCC member soci-eties asking to express their interest in the course.Eight countries responded and expressed their inter-est in hosting the C-CMBC course. Applicants werethen asked to attend the IFCC World Congress in Is-tanbul in June 2014 and to meet with the C-CMBCCommittee members for further discussions. Twocountries’ representatives met with the committeemembers and after fruitful discussion it was decided tohold the next course in Manila, Philippines. Dr. RomeoJoseph Ignacio, president, and Dr. Leila Florento, for-mer president of the Philippine Association of MedicalTechnologists (PAMET), Manila, acted as local partnercovering organizational issues. Dr. Florento was sentby the PAMET as a trainee to the Institute for ClinicalChemistry, in Mannheim, Germany to receive an intro-duction to the course and upon her return to the Philip-pines, she was instrumental in locating a suitable ven-ue for the course and confirming that all laboratory andlecture room requirements were met.

The Course was held from December 14–19, 2014,at the United Laboratories, Inc. in Manila. At the officialcourse start, the IFCC Tutors’ group was welcomed byDr. Ignacio and Dr. Florento. The course was attended

by 19 participants of heteroge-neous professional backgrounds inmolecular biology diagnostic skillsranging from “no idea” to “someDNA sequencing experience.” Thefirst day was dedicated to pre-course lectures, given by Dr. An-drea Ferreria-Gonzalez to bringeveryone to the same level. On thefirst day it was announced that oneparticipant would be chosen as anIFCC junior member based onhis/her performance during allthese days as well as on the re-sults of the final written evaluationexam. Every morning thereafterstarted with an introductory lecturefor the day’s practical and endedoff with informative and education-al lectures from the C-CMBC tu-tors. Students randomly divided themselves into 5groups for the practical sessions and followed a de-tailed practical manual provided by C-CMBC and print-ed by PAMET. All participants were enthusiastic aboutthe practicals, asked questions and performed all stepswith precision and in record time, resulting in success-ful solution preparation, DNA isolation, performing PCRreactions, allelic-specific DNA amplification, hybridiza-tion, and computer-lab work which entailed gene iden-tification in OMIM, variant analysis in SNPdp/SNPedia,primer design in Primer 3, NEB cutter for in silico re-striction fragmentation analysis. This was the first timethat a quantitative PCR experimental work was addedin the course. More specifically, the basics and clinicalapplications potential of qPCR were introduced to par-ticipants, by giving a specific lecture on that topic, andby combining this lecture with CMV quantitation in DNAisolated from peripheral blood. The last day finished offwith computer–lab work and state of the art lectures,followed by a 30 mark question paper, and coursequestionnaire and last but not least the IFCC-Certifi-cate Ceremony, where each participant received anIFCC certificate of completion and a CD containing all

the course lectures, practical videos, results from eachpractical session and photographs that were taken dur-ing the course. Thereafter, goodbyes were said witheveryone going their separate ways and back to theirrespective countries.

The hospitality and organization of all PAMETboard members was impeccable. Everything wasvery comfortable, friendly and well organized. C-CM-BC tutors were hosted by PAMET board members al-most every evening after the course. We would liketo thank all participants for their enthusiasm, and allthe PAMET board members for their excellent hospi-tality and perfect organization of the course. Wewould also like to thank all IFCC C-CMBC course2

sponsors: Biorad, Eppendorf, Lesser-Loewe Foun-dation, and Roche Diagnostics for providing essen-tial equipment and reagents.

References1 Lianidou et al, Advancing the education in molecular diag-

nostics: The IFCC-Initiative “Clinical Molecular Biology Cur-riculum” (C-CMBC); A ten year experience., Clin.Chim. Ac-ta, 2014, Sep 25; 436:5-8

2. IFCC C-CMBC Course Website: www.ifcc.org/ifcc-educa-tion-division/emd-committees/c-cmbc

IFCC Beginner’s Course in Molecular Diagnostics Held in Manila, Philippines

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine

Visit www.ifcc.org for more informationNEWS


prospects of young laboratorians. The first session was chaired by Dr. Maurizio Fer-

rari and Dr. Howard Morris. Dr. Graham Beastall ini-tiated the session by sharing his academic experi-ence in UK and worldwide as researcher and granti-ng authority. He explained the increasing role ofHealth authorities in medicine. The future specialistin Lab Medicine will require a strong background inthe basic medical sciences as well as highly devel-oped clinical skills. It is needed to develop the robustLaboratory Medicine and clinical research programsto improve healthcare and wellness of the popula-tion. Next, Dr. Pradeep Kumar Dabla (Chair IFCC-TFYS) gave a basic Introduction to Research Designexplaining what research is and its various steps inbrief. Research process consists of series of actionsor steps necessary to effectively carry out researchand the desired sequencing of these steps. Re-search comprises of defining and redefining prob-lems, formulating hypothesis or suggested solutions;collecting, organizing and evaluating data; makingdeductions and reaching conclusions; and at lastcarefully testing the conclusions to determinewhether they fit the formulating hypothesis. Prof.

Venkat Parameswaran (School of Medicine, Univ. ofTasmania) continued detailing Literature Review us-ing the Internet Support & Theoretical Approaches.He said “One of the most difficult steps when consid-ering research is to choose a right topic of interest.”This job of locating the background informationthrough systematic literature review nowadays hasbeen made easier through web-based “virtual library”facilities. Experimental approaches and analysis de-fines the information that is obtained.

Second session was chaired by Dr. Endang Ho-yaranda and Dr. Jayashree Bhattacharjee. Dr.Archana Singh (Assistant Professor, Biochemistry,AIIMS Delhi) described various quantitative andqualitative methods in detail. Generally, health sci-ence research follows the empirical approach, i.e.,based upon observation and experience and dealswith information of a quantitative nature. In either ap-proach, statistical reasoning using the laws of proba-bility guides the inferential process. Based on thesecalculated probabilities, the hypothesis is acceptedor rejected. In end Dr. Graham Beastall guided howto draft a research proposal and fine details required.He said “The way in which a research proposal isstructured and worded will have a significant impact

on its likely acceptance”. He stressed on allowingplenty of time to prepare the submission. Formulateyour research proposal into a hypothesis or series ofquestions informing the “Aims, Objectives and Out-comes” of your proposal to submit in time.

To summarize, the workshop has provided at-tendee’s sufficient understanding of the major para-digms of qualitative and quantitative research and toprovide a basis for further examination using pre-ferred method. This session has provided a vision tounderstand the research process including the iden-tification of a topic, preparation of a research propos-al and final research report and associated assess-ment criteria to prepare research proposal. Followingthe success of this symposium the IFCC ExecutiveBoard is considering a new project to support YS tobecome involved with clinical and scientific research.

For more information and queries: Dr. PradeepKumar Dabla, MD, Assistant Professor and Head,Department of Biochemistry, Chacha Nehru BalChikitsalya, Associated to Maulana Azad MedicalCollege; and Assistant Prof., Department of Bio-chemistry G.B. Pant Hospital & Institute of Postgrad-uate Medical Education Research, Delhi, India ChairIFCC-TF YS, E-mail: [email protected]

IFCC Leaders Attend Young Scientists Symposium at Jodhpur, IndiaCont’d from page 43

Photo: C-CMBC Course Tutors (from left to right: Dr. Parviz Ahmad-Nejad,Dr. Atsushi Watanabe, Dr. Evi Lianidou, Dr. Verena Haselmann, and Dr. An-drea Ferreira-Gonzalez).

Laboratory medicine professionals inRomania were previously organized

in two societies: the Romanian Societyof Laboratory Medicine (SRML), mem-ber of IFCC, EFLM, WASPaLM, andthe Romanian Association of MedicalLaboratories (ALMR) affiliated memberof IFCC and member of EFLM.

The members of both the organi-zations are medical doctors (special-ists in Laboratory Medicine), biolo-gists, biochemists, chemists, bio-physicists.

As their goals are similar, in 2014at the annual conferences of the twosocieties a step forward was achievedby taking the decision to create aunique, stronger society. A preliminarymeeting took place in September2014 and it was decided that thename of the new society will be theRomanian Association of LaboratoryMedicine (RALM). A temporary boardwas nominated, which will be incharge until the first RALM Congressin May 20–23, 2015, when electionswill be organized. The members of thetemporary board are Associate Pro-fessor Dr. Ioana Brudasca (president),Dr. Camelia Grigore (vice president),Dr. Ileana Funduc (vice-president), Dr.Cristina Florescu Moraid (member),and Dr. Daniela Miricescu (secretary).

The main goal of RALM is to sup-port a high quality healthcare man-agement, thus establishing stan-dards for scientific, technical, andethical aspects of good laboratorypractice.

As the clinical laboratory is an es-sential tool for clinical medicine,RALM will focus on the developmentand implementation of diagnostictests.

In order to fulfill these objectives,RALM will continue the activities ofthe two former societies.

RALM will organize annual con-ferences and congresses under theauspices of IFCC and EFLM, in part-nership with the Medical Faculties inRomania and with visiting lecturerssupported by IFCC and EFLM. Thesemeetings are an excellent opportuni-ty for laboratory medicine specialiststo benefit from the expertise of lead-ing scientists, to identify issues theyare confronted with in current prac-tice and to provide solutions andguidelines on how to solve them. Inorder to stimulate our young col-leagues, RALM will continue to granttwo awards at every conference forthe best poster presentation and formeritorious activity in the field of lab-oratory medicine.

The continuous Medical Educa-tion (CME) training courses for labo-ratory professionals organized untilnow will be continued, allowing ourmembers to stay connected to themost recent professional issues.

The former ALMR already had itsown publication, the Romanian Reviewof Laboratory Medicine (RRML), whichpublishes peer-reviewed original pa-pers, general and professional reportsof laboratory medicine. RRML is in-dexed in the ISI Web of Knowledge -Web of Science - Science Citation In-dex Expanded (Thomson Reuters Sci-entific), in the SCOPUS, and EMCAREdatabases since 2008, and in IndexCopernicus since 2009, and a memberof COPE since 2012. This journal willbecome RALM’s publication, providingthe opportunity for laboratory profes-sionals to update their knowledge inthe areas addressed.

We hope the new association willbe more effective in accomplishing itstasks and will contribute to a strongerand more visible profession in Roma-nia.

Romania’s Two Clinical Lab Societies Merge into

Single National Organizationby Ioana Brudasca, MD, PhD, RALM president

News from the World of the International Federation of Clinical Chemistry and Laboratory MedicineVisit www.ifcc.org for more information NEWS

145LMI-05-15LINKXPRESS COM45 LabMedica International

May/2015

Photo: Dr. Camelia Grigore (RSLM president) and the board of RAML at the 8thRAML conference in Sibiu 2014. From left to right: Dr. Minodora DobreanuRAML board member, Dr. chem. Ileana Funduc RAML vicepresident, Dr. chem.Ariana Radulescu RAML treasurer, Dr. Ioana Brudasca RAML president, Dr.Camelia Grigore RSLM president.

The 10th Congress of Clinical Bio-chemistry, organized by the Uru-

guayan Association of Biochemistry(ABU), “Automation: Evolution, Tech-nologies, and Strategies”, will takeplace on October 22–24, 2015 at theTelecommunications Tower, in Montev-ideo (Uruguay).

The Organizing Committee of the10th Congress of ABU is as follows:President: Rossana Pirotto; Vice presi-dent: Mercedes Castro; Secretary: Ce-cilia Queijo; Secretary: Lucila Pirez;Treasurer: Graciela Queiruga; Treasur-er: Paola Audicio; Members: LauraYametti, Beatriz Varela, Laura Godn-javec, Natalia Amor.

Scientific Committee: Chair: Gra-ciela Borthagaray; Members: CristinaServetto, Patricia Esperon, Stella Ray-mondo, Graciela Queiruga and AnaLena.

Themes: Assisted Reproduction;Drug Abuse; Quality Management; Mi-crobiology; Microarrays and Sequenc-ing of the Genome; Standardization.

Uruguay’s National Congress Scheduled for October 2015

IFCC OFFICE

Via Carlo Farini 81, 20159 Milan, ITALYTel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846E-mail: [email protected] • Web: www.ifcc.orgOffice Hours: 9.00-13.00 and 14.00-18.00Staff Members: Paola Bramati, Silvia Cardinale,Silvia Colli-Lanzi

Anyone may need to seek treatment abroad,particularly in another State of the European

Union (EU), for various personal, medical or pro-fessional reasons. Beyond national regulations,the directive 2011/24/EU of March 9, 2011, on theapplication of patients’ rights in cross-borderhealthcare makes provision for the introduction ofa general framework to clarify patients’ rights with

regard to accessing cross-border healthcare provi-sion, guarantee the safety, quality and efficiency ofcare that they will receive in another EU MemberState; promote cooperation between MemberState on healthcare matters. The directive hasidentified the need to circulate medical data fromone Member State to another when their citizensare traveling; but how to be able to have access to

relevant information for appropriate care or re-search purposes remains to be seen.

While there is currently a wide range of ap-proaches in the various countries of the EU forstoring and sharing patient data, none of theselend themselves easily to cross border use, atleast in their current form. In Germany, there is asystem based on smart cards but currentlyhealthcare personnel in other countries cannotread this card. In France the Dossier Médical Per-sonnel (Personal Medical Record, DMP) is acomputer resource intended mainly for Frenchmedical personnel, to which the patient has on-line access to validate personal data. In additionto access problems, there are major differencesin the content of the information that they contain.Thus, the United Kingdom has opted for a nation-al summary care record (SCR) system only con-taining information relating to drugs, allergies anddrug reactions. Moreover, there are also signifi-cant differences regarding the conditions for ac-cess to data and control of their confidentialityamong the many concurrent systems of the EU.Clearly, despite the directive, there is no Europe-wide agreement on either the substance or theform of the data to be compiled. Likewise, there isno general agreement concerning software, tech-nical standards or readers. In the absence of har-monization, a common protocol for access to es-sential information would be useful. As operatorslike Orange* have emphasized, the solution todata sharing must be integrated into the practicesof physicians and hospitals. This must be easy touse and inexpensive. Common semantic stan-dards understood by everyone need to be devel-oped. It is also necessary to ensure that data en-try is secure and reliable. Finally, widely differentand incompatible formats and standards are usedfor provision of healthcare using ICTs throughoutthe EU. This is creating both obstacles to thismode of cross-border healthcare provision andpossible risks to health protection. Also, it is nec-essary to aim at interoperability of ICT systemsand it is important to work on interoperability andrespect the division of competences and to sup-port patient access to eHealth applications.

In France, on another level, many stakehold-ers from private associations and the healthcareand research industries are requesting that databe open and accessible. This led to debate whendrafting the Health Act, which plans to combinemajor medical administrative databases (reim-bursements for care, hospital stays, and datafrom facilities for people with disabilities, causesof death) in a national health data system (NSDS)and to facilitate access for public interest purpos-es. This openness would represent an opportuni-ty of primary importance to biomedical research,public health research and the social sciences.Ultimately, health data analysis will help to basehealth policies on objective factors. Matching upmedico-administrative databases and clinical, bi-ological, economic and sociological studies, aswell as cohorts or other epidemiological surveyswill permit better understanding and acting moredirectly to the health system, or more concretelyon the organization of the course of care andhealth, on drug use, on the conditions of expo-sure of individuals to their environment, on risksin the workplace, or on the fight against social in-equalities in health. It's ambitious, however, andthe protection of personal data, confidentiality, re-spect for privacy and research ethics must be aconstant requirement.

by Dr. Bernard GougetChair, COC and Co-President EuroMedlab Paris 2015;SFBC-EFLM Representative; Secretary General, International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML)

How to Share Health-Related Data for Better Care?

European Federation of Clinical Chemistry and Laboratory Medicine

EFLM CORNEREdited by Dr. Bernard Gouget


Croatian Society for Medical Bio-chemistry and Laboratory Medi-

cine (CSMBLM) and Croatian Centerfor External Quality Assessment(CROQALM) have jointly organizedan educational workshop on 24 April,2015 in Zagreb (Croatia). The target-ed audiences of this one day work-shop were the new recently appoint-ed members of the CROQALM andassistant editors of Biochemia Med-ica, the scientific journal published byCSMBLM.

CSMBLM has a 30-year traditionof running EQA in the field of clinicalchemistry, hematology and coagula-tion. EQA samples are sent threetimes per year to all Croatian labora-tories and participation is mandatory.Since recently, CROQALM has alsolaunched pre- and post-analyticalEQA modules, based on clinical cas-es with questions (type 1 EQA)1. Par-ticipation in pre-and post-analyticalmodules is only educational.

The aim of this workshop was toprovide education to newly appointedmembers of our CROQALM team.Our desire was to learn from es-teemed speakers and obtain valu-able knowledge and information inorder to be able to improve the serv-ice we provide to our members.

Speakers of the workshop wereinternationally renowned experts inthe field of External quality assess-ment (EQA) who have provided highquality presentations on various top-ics. Prof. Egon Amann from Ger-many, who is the chair of the IFCCCommittee for Analytical Quality (C-AQ), has given a comprehensiveoverview of the role of EQA in labo-ratory quality management. AnnetteThomas (UK), Director of the Quali-ty Laboratory and Scheme organizerof Weqas, spoke about the neces-sary steps and prerequisites to suc-cessfully organize and run the na-tional EQA. She also gave an excel-

lent presentation about the way toestablish participant performance bysetting appropriate performance cri-teria. Specific issues like samplecommutability, stability and homo-geneity were covered by Piet Meijer,a Director of the ECAT Foundation(External Quality Control for Assaysand Tests with a focus on Thrombo-sis and Hemostasis), from theNetherlands, who also gave a greatlecture on some specific issues andsolutions for running a successfulEQA in coagulation. Barbara De laSalle, Scheme Director at UKNEQAS for General Hematologyhas presented an excellent overviewof various advantages and disad-vantages of different sample typesfor running EQA in hematology. Fi-nally, statistical analysis and datapresentation were overviewed byWim Coucke, from the Scientific In-stitute of Public Health in Brussels(Belgium).

Each lecture was followed by afruitful discussion and the workshopwas rated as very useful and suc-cessful by all participants as well asby speakers. The possibility to learnfrom such experts who have kindly

agreed to share their knowledge withparticipants is indeed priceless. Wehave learned a lot and we hope thatthis workshop will help us to improveour EQA services in the future.

Literature:1. Kristensen GB, Aakre KM, Kristof-fersen AH, Sandberg S. How to con-duct External Quality AssessmentSchemes for the pre-analytical phase?Biochem Med 2014;24(1):114-22.

Photo: CROQALM workshop speakersand the members of the ExecutiveBoard of the Croatian Society of Med-ical Biochemistry and Laboratory Med-icine. On the picture, from left to right:Wim Coucke, Annette Thomas, Bar-bara de la Salle, Piet Meijer, EgonAmann, Ana-Maria Simundic (CSM-BLM President), Jasna Lenicek-Krleza(CROQALM chair), Manuela MileticLovric (CSMBLM Secretary), IvanaCelap (CROQALM vice-chair), DariaPasalic (CSMBLM Vice-President)

EFLM’s International Experts Conduct Workshop in Croatia

European Federation of Clinical Chemistry and Laboratory Medicine

EFLM CORNER



15th EFLM Continuing Postgraduate Course To Be Held in Dubrovnik (Oct 24-25, 2015)

EFLM is pleased to announce that the 15th EFLM Continuing PostgraduateCourse in Clinical Chemistry and Laboratory Medicine, known as “Dubrovnik

Course,” will be held for the first time in Zagreb on October 24–25, 2015.This advanced course entitled “How to assess the quality of your method?” is

organized by EFLM in cooperation with the Croatian Society of Medical Biochem-istry and Laboratory Medicine (CSMBLM) and Slovenian Association of ClinicalChemistry and Laboratory Medicine (SACCLM).

For 14 years now, the Dubrovnik Courses were successfully organized as oneof advanced postgraduate courses in the frame of the programs of the Interuniver-sity Center Dubrovnik. To make this Course more accessible to participants, it wasdecided to move it to different venues in South-East Europe. This year, the select-ed venue is Zagreb.

The bursaries of EFLM, CSMBLM and SACCLM will be available to partici-pants presenting posters.

Deadline for abstract acceptance is May 15, 2015. Take advantage of early registration and register yourself!For further information, please visit: www.eflm-course.org


EFLM CORNER European Federation of Clinical Chemistry and Laboratory Medicine

The Lithuanian Society of Labora-tory Medicine is the main Lithuan-

ian society, which unites specialistsin laboratory medicine—laboratorymedicine physicians and medical bi-ologists working in clinical laborato-ries as well as carrying out researchat universities and institutes. It is alsoopen for laboratory technicians andstudents for participation in the edu-cational events and training. Current-ly 250 specialists of laboratory medi-cine are full members of the Society.

On April 17, 2015, the VII AnnualConference of the Lithuanian Societyof Laboratory Medicine was held inVilnius, at the Crowne Plaza Confer-ence Center. More than 200 partici-pants attended this event titled “Roleof laboratory medicine in chronic dis-eases management.”

It is expected that in Europe aver-age life span will increase. One ormore chronic diseases might burdenthe advancing age of many Euro-peans. The incidence of these dis-eases is climbing alarmingly. Averageexpenditures for health care are in-

creasing rapidly at older age. Chron-ic disease costs could have a severeimpact on health care system. This iswhy the shift from treatment to pre-vention and management of chronicdiseases is in need. Today’s labora-tory medicine – automated, digital-ized, and accredited – plays a majorrole in accelerating this shift and pro-vide innovative tools for chronic dis-eases screening, early detection andmanagement in order to extendhealthy life years.

Six plenary presentations cov-ered wide range of topics related tothe most prevalent and critical chron-ic diseases. The Conference startedwith Sten Westgard (USA) presenta-tion on the importance of knowingthe state of analytical quality, choos-ing the right goals and right methodsfor quality control. Next speaker Na-talie Le Bastard (France) presentedthe newest data on application ofcerebrospinal fluid biomarkers forearly diagnosis of Alzheimer dis-ease. Radvile Malickaite (Lithuania)reviewed determination of immunity

response to M. tuberculosis meas-ured by production of gamma inter-feron. Nicholas Mills (UK) highlight-ed analytical and clinical issues ofhigh sensitive cardiac troponin I test-ing in patients with suspected acutecoronary syndrome, especially of im-plementing gender specific normalranges. Astra Vitkauskiene (Lithua-nia) shared her experience of theHospital of Lithuanian University ofHealth Sciences Kaunas Clinics inlaboratory diagnostics and manage-ment of cystic fibrosis. The last pres-entation, given by Vytenis Kalibatas(Lithuania), summarized availabletools provided by laboratory medi-cine for prevention of chronic dis-eases, helping to cope with chal-lenges and opportunities in today’sdifficult socioeconomic environment.

The Conference agenda also in-cluded IVD manufacturers’ sessionand exhibition of diagnostic compa-nies. Laboratory specialists were pro-vided with information about newproducts and solutions useful in thelaboratory routine. At the same time,Board of the Society in the separatemeeting session presented summaryof activities and financial situation ofthe year 2014. Main presented activ-ities: national recommendations andguidelines related to pre-analyticalphase (patient preparation and sam-pling, sample storage and transporta-tion, specimen preparation), post-graduate training of laboratory medi-cine specialists, promotion of labora-tory technicians’ participation in Soci-ety activities, and development ofdedicated website www.llmd.lt. Lateron a Task Force for clinical microbiol-ogy was approved. The main goals ofthe Task Force is to initiate and coor-dinate clinical microbiology proce-dures and national documentation, toprovide guidance on quality assur-ance and accreditation for clinical mi-crobiology laboratories across thecountry, to cooperate with Lithuanianspecialists of infectious diseases.

Delegates of the meeting unitedlyvoted for the policies of the year2015. Major tasks include prepara-tion of recommendations on laborato-ry tests quality management, guide-lines on selection of secondary labo-ratory and advisory services, externalquality assurance and recommenda-tions for authorities performing labo-ratory certifications. It was decided tocontinue evolving documents onpostgraduate training of laboratorymedicine specialists. Tasks of aWorking group on Pediatric Labora-tory Medicine were approved.

One day before the Congress, onof April 16, 2015, an exciting work-shop took place in Crowne Plaza Vil-nius. Over 60 laboratory managersand quality control specialists fromLithuanian and Latvian laboratoriesattended workshop conducted bySten Westgard, world-recognizedauthority in quality management oflaboratory medicine. The workshopcovered two important topics. Thefirst one titled “Six Sigma Design andError Budgets” focused on six-sigmaconcept, the questions how tochoose right quality goal and tomake metrics work for the laboratory.The second topic of the workshop“Introduction to Risk Analysis andRisk Management” was dedicated todiscuss risk management role in en-suring patient safety and differentguidelines for risk analysis and qual-ity control.

In the evening, there was a socialevent at the Merchants’ Club with un-forgettable concert given by famousLithuanian opera singer Sigute Stonyteand pianist Jurgis Karnavicius.

The Board of Lithuanian Societyof Laboratory Medicine would like tothank everyone who made this Con-ference such a success: the speak-ers for sharing their valuable insightsand expertise, the chairs for keepingeverything running in time and labo-ratory specialists for their active par-ticipation in this meeting.

7th Annual Conference of theLithuanian Society of Laboratory

Medicine: A Report


AAnew healthcare market studyfinds that in addition to Brazil,

there are smaller countries in LatinAmerica that are also top targets forin vitro diagnostics (IVD) firms astheir IVD sectors are projected togrow at faster rates.

Kalorama Information (New York,NY, USA; www.kaloramainformation.com) said that Brazil figures heavilyinto IVD strategies for the LatinAmerican continent with a popula-tion of over 200 million people andindustry to support globally distrib-uted supply operations. However,Brazil’s regional economic clout maynot ensure its status as a leading tar-get IVD expansion market. Accord-

ing to Kalorama’s latest projectionsfor Latin American IVD, the lesscompetitive markets of Chile,Colombia, and Peru are expected togrow by faster rates through 2019while outpacing growth for LatinAmerican IVD as a whole. WhileBrazil can claim preeminence interms of scale, these and other fac-tors have made other South Ameri-can markets increasingly relevant toglobal IVD expansion.

The findings were made in Kalo-rama’s new report: The Market for InVitro Diagnostic Tests in Latin Amer-ica (Colombia, Brazil, Peru, Argenti-na, Chile, Venezuela, Ecuador, andOther Nations).

Growth Projected for Latin America’s IVD Sector

LLab automation systems sold toclinical laboratories around the

world reached USD 5.4 billion in salesin 2014. Shortage of personnel willfurther drive these purchases, as will aneed for new systems, according to anew market research report on the sta-tus of lab automation in both clinicaland drug-discovery lab segments.

The new report “Lab AutomationMarkets, 4th Edition” by Kalorama In-formation (New York, NY, USA;www.kaloramainformation.com) saysthat annually in the US only about4,000 students graduate in lab tech-nology, while current professionals arereaching retirement age in dispropor-tionate numbers. Among the causes ofthis labor shortage is increased de-mand in alternate and complex labtesting facilities. Laboratory personnel

are being hired in physicians' offices,central clinical laboratories, veterinari-ans' offices, industrial laboratories, andresearch laboratories. Clinical labwork remains a hidden profession:lack of public knowledge about profes-sional lab opportunities is evidentwhen people are questioned aboutwhat careers are available in the med-ical field – few are aware of the varietyavailable in the medical field otherthan doctors, nurses, and paramedics.

“The shortage of medical technolo-gists is becoming more significantevery year as fewer students enter thefield,” said Joe Constance, Kaloramaanalyst and author of the report, “Atthe same time the aging baby-boomerpopulation is generating increased de-mand for medical testing. Only au-tomation can bridge this gap.”

Global Market for Clinical Lab AutomationEstimated at USD 5.4 Billion and Growing

BB io-Rad Laboratories, Inc. (Her-cules, CA, USA; www.bio-rad.

com), a global provider of life scienceresearch and clinical diagnostic prod-ucts, and clinical diagnostics leaderBeckman Coulter Diagnostics (Brea,CA, USA; www.beckmancoulter.com), have announced that Bio-Radis extending its agreement with Beck-man Coulter and has named the com-pany exclusive global distributor ofBio-Rad’s Access HIV combo assayand Access Hepatitis C virus (HCV)assay in select geographies. The prod-ucts are currently not available in theUS or Vietnam.

The 10-year exclusive distributionrights agreement is part of an exten-sion of the manufacturing and supply

agreement that began nearly 20 yearsago for blood virus and infectious dis-ease immunodiagnostic testing.

“This partnership with Bio-Rad en-ables Beckman Coulter Diagnosticsto deliver on its commitment to cus-tomers by providing a broad im-munoassay menu that allows them tooptimize laboratory workflow,” saidJohn Blackwood, senior vice presi-dent, Chemistry and ImmunoassayBusiness Unit, Beckman Coulter Di-agnostics, “With the new HIV comboassay and HCV assay running on theBeckman Coulter UniCel DxI andAccess systems, we enable physiciansto better diagnose and treat patientswith blood viruses and infectious dis-eases.”

Bio-Rad Extends Exclusive Distribution ofTwo Infectious Disease Tests by Beckman

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JUNE 2015Biomarkers World Europe. Jun 2-3; London, UK; Web: www.healthnetworkcommunications.com

European Human Genetics Conference2015. Jun 6-9; Glasgow, UK; Web: www.eshg.org

EAACI 2015 – 31st Eur. Cong. of Aller-gology and Clin. Immunology. Jun 6-10; Barcelona, Spain; Web: www.eaaci2015.com

European Society for Human Reproduc-tion and Embryology Annual Meeting –ESHRE 2015. Jun 14-17; Lisbon, Portu-gal; Web: www.eshre2015.eu

2015 BIO International Convention. Jun15-18; Philadelphia, Pennsylvania; Web:http://convention.bio.org

Canadian Laboratory Medicine Con-gress. Jun 20-24; Montreal, Canada; Web:www.clmc.ca/2015

EuroMedLab 2015 - 21th IFCC-EFLMEuropean Congress of Clinical Chem-istry and Laboratory Medicine / JIB2015. Jun 21-25; Paris, France; Web:www.paris2015.org

JULY 2015AACC 2015 – 66th Annual Meeting ofAmerican Association for ClinicalChemistry. Jul 26-30; Atlanta, GA, USA;Web: www.aacc.org

AUGUST 2015FIME 2015 – Florida International Med-ical Exhibition. Aug 5-7; Miami, FL,USA; Web: www.fimeshow.com

Biochemical and Molecular Basis ofMultifactorial Diseases. Aug 21-Oct 23;Moron, AR; Web: www.ifcc.org

SEPTEMBER 20156th International Conference and Exhi-bition on Analytical & Biochemistry andLaboratory Medicine. Sep 1-3; Valencia,Spain; Web: http://analytical-bioanalytical.pharmaceuticalconferences.com

Biotech China 2015. Sep 3-5; Nanjing,China; Web: http://en.biotechchina-nj.com

34th International ISBT – InternationalSociety Blood Transfusion Congress. Sep4-8; Dubai, UAE; Web: www.isbtweb.org

ESP 2015 – 27th European Congress ofPathology. Sep 5-9; Sava Centar, Belgrade,Serbia; Web: www.esp-pathology.org

18th Annual Meeting of the ESCV – Eu-ropean Congress of Virology. Sep 9-12;Edinburgh, Scotland; Web: www.escv.org

Eurotox 2015 – 51st Congress of the Eu-ropean Societies of Toxicology. Sep 14-16; Porto, Portugal; Web: www.euro-tox2015.com

MEMBS 2015 – 2nd Middle East Molec-ular Biology Congress and Exhibition.

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– EuroMedLab Paris 2015 . . .46139 Greiner . . . . . . . . . . . . . . . .39138 Hecht, Karl . . . . . . . . . . . . .38133 Instrumentation Laboratory .33

– LabMedica.com . . . . . . . . . . .6127 Medica . . . . . . . . . . . . . . . . .27

– MEMBS 2015 . . . . . . . . . . .49125 Mindray . . . . . . . . . . . . . . . .25105 Randox . . . . . . . . . . . . . . . . .5136 Rayto . . . . . . . . . . . . . . . . . .36111 Sekisui . . . . . . . . . . . . . . . . .11147 SFRI . . . . . . . . . . . . . . . . . .47121 Siemens Healthcare . . . . . .21107 SNIBE . . . . . . . . . . . . . . . . . .7122 SNIBE . . . . . . . . . . . . . . . . .23120 Socorex . . . . . . . . . . . . . . . .20109 Thermo Scientific . . . . . . . . .9131 Thermo Scientific . . . . . . . .31

– Trademed.com . . . . . . . . . .22142 Vicotex . . . . . . . . . . . . . . . .42117 Waters . . . . . . . . . . . . . . . . .17145 West Medica . . . . . . . . . . . .45

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Analitica Latin America 2015 Interna-tional Exhibition of Laboratory Technol-ogy, Analyses, Biotechnology and Quali-ty Control. Sep 22-24; Sao Paulo, Brazil;Web: www.analiticanet.com

ExpoMedical 2015. Sep 23-25; BuenosAires, Argentina; Web: www.expomedical.com.ar

ESPT 2015 - 3rd Conference on Integra-tion of Pharmacogenomics in ClinicalDecision Suport. Sep 24-26; Budapest,Hungary; Web: www.esptcongress.eu

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BIOTECHNICA 2015. Oct 6-8; Han-nover, Germany; Web: www.biotechnica.de

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Congress on Pathology and LaboratoryMedicine. Nov 18-21; Cancun, Mexico;Web: www.pathologycancun2015.org

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