NasoSwab™Collection and Transport Device

MDL’s NasoSwab™ is an anatomically engi-neered collection device that specifically targets the mid-turbinate region of the nasal passageway. The length and design of the swab allows for con-sistent specimen collection. The unique conical shape and use of Flocked technology combine to provide an increased surface area with greater particle retention than traditional swabs. Sprayed-on nylon fibers provide a velvet-like texture that serves to both disrupt and capture pathogenic particles. When placed in transport media, a high percentage of sampled particles are released as opposed to traditional swabs that trap particles within their fibers. Higher yields are achieved, im-proving the accuracy of diagnostic testing.

222 Adenovirus by Real-Time PCR

1101 Bordetella parapertussis by Real-Time PCR

1102 Bordetella pertussis by Real-Time PCR

319 Chlamydophila pneumoniae by Real-Time PCR

1112 Group A Streptococcus by Real-Time PCR

1114 Human Bocavirus by Real-Time PCR

1115 Human Coronavirus by Real-Time PCR

(Human Coronaviruses 229E, OC43, NL-63)

1105 Human Metapneumovirus by Real-Time PCR

1106 Influenza A Virus by Real-Time PCR

(Reflex to Amantadine Resistance by Pyrosequencing)

1107 Influenza B Virus by Real-Time PCR

1109 Moraxella catarrhalis by Real-Time PCR

336 Mycoplasma pneumoniae by Real-Time PCR

1110 Parainfluenza Viruses 1-4 by Real-Time PCR

1103 Respiratory Syncytial Virus A (RSV A) by Qualitative PCR

1104 Respiratory Syncytial Virus B (RSV B) by Real-Time PCR

1111 Streptococcus pneumoniae by Real-Time PCR

Respiratory Infectious Diseases

- ONE VIAL- High diagnostic sensitivity and specificity- No refrigeration / freezing required- Stable for five (5) days after collection- Flocked swab technology- Simple, convenient, less invasive- Contours to the mid-turbinate region- Nylon flocked nasal swab absorbs and releases more sample particles

The introduction of molecular techniques, such as PCR technology, together with Flocked swab technology, offers a superior detection route of respiratory tract infection. MDL offers a number of assays for the detection of multiple pathogens associated with respiratory tract infections. The unrivaled sensitivity and specificity of the real-time PCR method in detecting infectious agents provides the clinician with an accurate and rapid means of diagnosis, with a turnaround time of 24-48 hours. This valuable diagnostic tool will assist the clinician with diagnosis, early detection, patient stratification, drug prescription and prognosis. No refrigeration or freezing of the specimen is required. The specimen is stable for five days after collection. Order detection for any patho-gen listed below from the NasoSwab™ menu.

NasoSwab™

Medical Diagnostic Laboratories, L.L.C.

Founded in 1997, Medical Diagnostic Laboratories, L.L.C. (MDL) serves mainly as a reference laboratory for Polymerase Chain Reaction (PCR) based test-ing to laboratories, hospitals, and physicians worldwide. MDL is a CLIA certified infectious disease laboratory with multiple state licenses specializing in PCR technology. The continued success of MDL is attributed directly to client retention and the ability to provide customized services. Enhanced turnaround-time, cost-effectiveness and the capability to tailor services to best suit the needs of our clients gives MDL a distinct advantage over its competitors.

MDL specializes in high complexity, state-of-the-art, automated DNA-based molecular analysis. By using molecular techniques, MDL is able to provide clinicians from many different specialties valuable diagnostic information to assist in the detection, diagnosis, evaluation, and treatment of viral, fungal, and bacterial infections. For example, the unique testing MDL offers for the specialties of Urology and Gynecology enables the detection of multiple pathogens from a single swab by PCR. MDL’s primary focus is in the field of infectious disease testing for Urology, Obstetrics and Gynecology, Respiratory Infectious Diseases, Vector-borne Diseases, Mycology.

MDL’s Research and Development Department is comprised of experts in the fields of Molecular Biology, Immunology, Pharmacogenomics, Virology, Mi-crobiology, and Oncology. In addition to developing and validating new clinical tests, the Research and Development Department also publishes research projects in peer-reviewed journals, presents scientific information at international symposia, and performs contractual research work for major commercial, governmental, and academic organizations.

MDL is recognized for its continued excellence in participation in the proficiency testing program administered by the College of American Pathologists (CAP). MDL is licensed in multiple states, including New Jersey, New York, Florida, and California. As a result, MDL is regularly inspected by the New York State Department of Health, New Jersey State Department of Health, and the Federal CLIA program and must adhere to strict regulations and quality control guidelines. MDL has continually maintained exemplary ratings by these agencies.

High diagnostic specificity and sensitivityPCR technology - DNA amplificationUnique ability to analyze multiple pathogens from a single swabRapid result turnaround time of 24-48 hoursNo refrigeration required before or after collection

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Specimen viability up to five (5) daysBlood or excess mucus will not affect resultsMicrobial drug resistance profilesFlocked swab technology High precision robotic accuracy

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New Jersey - Clinical Laboratory License - ID #0000875Florida - Clinical Laboratory License - ID #800014396New York - Clinical Laboratory Permit - PFI #7469Maryland - Medical Laboratory Permit - ID #1133

Pennsylvania - Clinical Laboratory Permit - ID #026538Rhode Island - Clinical Laboratory License - ID #LCO00420California - Clinical Laboratory License - ID #COS800136CLIA - ID #31D0938156

The testing offered by Medical Diagnostic Laboratories, L.L.C. is developed and validated by MDL’s Research and Development Department. The R&D Department performs studies on sensitivity, specificity, interference, optimization, accuracy, and precision prior to offering testing for a specific pathogen by PCR. These studies are used to establish the ability of the PCR method to detect specific genetic sequences of a target pathogen within a given clinical specimen. Validation studies are available upon request.

Overview

Advantages

Laboratory Licenses & Permits

Our result reporting option can be customized upon request to best suit the individual needs of your practice. One or more of the following currents meth-ods of reporting can be selected:

Some benefits of utilizing Labtest.com include secure, immediate access to patient results using your existing computer and internet access. Test results are posted as soon as they are available and may be sorted by patient name, ID number, date of service, date of birth, sex, or accession number. Secure Socket Layer (SSL) encryption is activated when results are displayed and therefore sensitive data cannot be intercepted during transmission. Labtest.com displays easy-to-read, customizable report views which indicate reference ranges and highlight abnormal results in red. To ensure perfect hard copies every time, one report view is “print-ready”. Additional copies of the test reports can be forwarded to other physicians upon the ordering physician’s written request in the designated area of test requisition form.

FaxFirst class mailOvernight DeliveryWeb-based result reporting via Labtest.com

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Results

Patient Information (Please Print) Ordering Physician/LaboratoryName (Last, First): Physician’s Name: UPIN / NPI #:

In Care of: Address:

Patient Address: 2nd Address:

City: State: Zip: City: State: Zip:

Female Male (Required) Date of Birth (Required): Phone Number: Fax Number:

Patient SSN: Patient ID #: Physician’s Signature: Date:

Phone Number (9 am to 5 pm): Physician to receive additional result report:

Billing Information (Please include a copy of the front & back of card, if available.) Patient Billing Insurance Billing Lab Account Physician Account

Relation: Spouse Self Dependant

ICD9 Codes (Required): Please provide all diagnosis codes applicable for tests medically necessary for the diagnosis and treatment of the patient.

1. 2. 3. 4.Primary Insurance Carrier: Claims Address:

Insured’s Name (if not Patient): Medicare, Medicaid or Policy ID #:

Insured’s SSN: Insured’s DOB: Employer / Group Name: Group #:

Specimen InformationDate Collected (Required): Time Collected: Specimen Source: Comments:

Test Selection

Test Requisition Form

FOR LAB USE ONLY

MEDICAL DIAGNOSTIC LABORATORIES, L.L.C.2439 Kuser Road • Hamilton, NJ 08690-3303

(609) 570-1000 • Fax (609) 570-1050Toll Free (877) 269-0090

www.mdlab.com

PEDIATRIC & ADULTRESPIRATORY INFECTIOUS DISEASES (NasoSwab™ Only)

222 Adenovirus by Real-Time PCR

1101 Bordetella parapertussis by Real-Time PCR

1102 Bordetella pertussis by Real-Time PCR

319 Chlamydophila pneumoniae by Real-Time PCR

1112 Group A Streptococcus by Real-Time PCR

1114 Human Bocavirus by Real-Time PCR

1115 Human Coronavirus by Real-Time PCR(Human Coronaviruses 229E, OC43, NL-63)

1105 Human Metapneumovirus by Real-Time PCR

1106 Influenza A Virus by Real-Time PCR(Reflex to Amantadine Resistance by Pyrosequencing)

1107 Influenza B Virus by Real-Time PCR

1109 Moraxella catarrhalis by Real-Time PCR

336 Mycoplasma pneumoniae by Real-Time PCR

1110 Parainfluenza Viruses 1-4 by Real-Time PCR

1103 Respiratory Syncytial Virus A (RSV A) by Qualitative PCR

1104 Respiratory Syncytial Virus B (RSV B) by Real-Time PCR

1111 Streptococcus pneumoniae by Real-Time PCR

TICK-BORNE DISEASES

410 Babesia microti by Real-Time PCR

419 Babesia microti IgG by ELISA (serum required)

431 Babesia WA1 by Real-Time PCR

355 Bartonella henselae IgG by ELISA (serum required)

317 Bartonella henselae by Real-Time PCR

424 Borrelia afzelii by Real-Time PCR

425 Borrelia garinii by Real-Time PCR

430 Borrelia lonestari by Real-Time PCR

411 Ehrlichia chaffeensis (HME) & Anaplasma phagocytophilum (HGE) by Real-Time PCR

305 Lyme disease (B. burgdorferi) by Real-Time PCR

427 Lyme disease IgG/IgM by ELISA (serum required)

417 Lyme disease C6 Peptide by ELISA (serum required)

313 Lyme disease Western blot (IgG/IgM) (serum required)

416 Rickettsia rickettsii (RMSF) by Real-Time PCR

7/2007

The federal government requires that physicians only order tests that are medically necessary for the diagnosis and treatment of a patient. MDL offers individual tests, as well as a limitednumber of customized panels. Please take care in selecting only those tests that are medicallynecessary. If you check off a panel as your choice, MDL understands all of the componenttests to be medically necessary, and will perform, report and bill for all such component tests.

VIROLOGY222 Adenovirus by Real-Time PCR207 Cytomegalovirus (CMV) by Real-Time PCR233 CMV IgG/IgM by ELISA (serum required)205 Epstein-Barr virus (EBV) by Real-Time PCR231 EBV-EA-D IgG/IgM by ELISA (serum required)230 EBV-EBNA-1 IgG/IgM by ELISA (serum required)229 EBV-VCA IgG/IgM by ELISA (serum required)267 HBV Subtyping by Pyrosequencing268 HBV Genotyping by Pyrosequencing (Drug Resistance)252 HCV Subtyping by Pyrosequencing* (#250 Req.)262 Hepatitis A virus (HAV) by Real-Time PCR260 Hepatitis B virus (HBV) viral load by Real-Time PCR250 Hepatitis C virus (HCV) viral load by Real-Time PCR220 Hepatitis G virus (HGV) by Real-Time PCR113 Herpes simplex virus (HSV) viral load by Real-Time PCR* (#126 Req.)126 Herpes subtype (HSV-1, HSV-2) by Real-Time PCR257 HSV-1 IgG by ELISA (serum required)258 HSV-2 IgG by ELISA (serum required)254 HIV-1 by Western blot (serum required)253 HIV-1 & 2 by Enzyme Immuno Assay (EIA) (serum required)255 HIV-1 viral load by Real-Time PCR238 Human herpesvirus-6 (HHV-6) IgG by ELISA (serum required)219 Human herpesvirus-6 (HHV-6) Variants A & B by Real-Time PCR263 Human herpesvirus-7 (HHV-7) by Real-Time PCR221 Human herpesvirus-8 (HHV-8) by Real-Time PCR203 Human T-lymphotropic virus I (HTLV-I) by Real-Time PCR223 Parvovirus by Real-Time PCR138 Polyomavirus BK by Real-Time PCR (UroSwab® or blood)139 Polyomavirus JC by Real-Time PCR (UroSwab® or blood)264 St. Louis Encephalitis virus by Real-Time PCR215 Varicella-Zoster virus (VZV) by Real-Time PCR243 West Nile virus by Real-Time PCR244 West Nile virus IgG / IgM by Western blot (serum required)265 Western Equine Encephalitis virus by Real-Time PCR

OTHER TESTS

The federal government requires that physicians only order tests that are medically necessary for the diagnosis and treatment of a patient. MDL offersindividual tests, as well as a limited number of customized panels. Please take care in selecting only those tests that are medically necessary. If you check off apanel as your choice, MDL understands all of the component tests to be medically necessary, and will perform, report and bill for all such component tests.

MYCOLOGY553 Aspergillus fumigatus by Real-Time PCR551 Candida albicans by Real-Time PCR576 Candida dubliniensis by Real-Time PCR559 Candida glabrata by Real-Time PCR578 Candida kefyr by Real-Time PCR566 Candida krusei by Real-Time PCR577 Candida lusitaniae by Real-Time PCR558 Candida parapsilosis by Real-Time PCR557 Candida tropicalis by Real-Time PCR554 Cryptococcus neoformans by Real-Time PCR550 Pneumocystis carinii by Real-Time PCR555 Trichosporon by Qualitative PCR

* This test can only be performed when the test in parenthesis is positive. All tests performed will be billed.

BACTERIOLOGY326 Bartonella bacilliformis by Real-Time PCR325 Bartonella clarridgeiae by Real-Time PCR339 Bartonella elizabethae by Real-Time PCR317 Bartonella henselae by Real-Time PCR342 Bartonella quintana by Real-Time PCR356 Bartonella Species by Real-Time PCR

Bartonella henselae, Bartonella quintana

352 Bordetella pertussis (IgG/IgA) by Western blot (serum required)321 Brucella genus by Qualitative PCR

B. abortus, B. melitensis, B. ovis, B. suis

319 Chlamydophila pneumoniae by Real-Time PCR327 Chlamydophila pneumoniae IgG/IgM by ELISA (serum required)104 Chlamydia subtype by Real-Time PCR C. pneumoniae, C. trachomatis

105 Chlamydia trachomatis by Real-Time PCR310 Helicobacter pylori by Real-Time PCR

(Reflex to clarithromycin resistance by Pyrosequencing)

353 Helicobacter pylori (IgG/IgA) by Western blot (serum required)318 Legionella pneumophila by Real-Time PCR332 Mycoplasma fermentans by Real-Time PCR301 Mycoplasma general by Qualitative PCR129 Mycoplasma genitalium by Real-Time PCR130 Mycoplasma hominis by Real-Time PCR335 Mycoplasma penetrans by Qualitative PCR336 Mycoplasma pneumoniae by Real-Time PCR340 Mycoplasma pneumoniae IgG/IgM by ELISA (serum required)145 Neisseria gonorrhoeae by Real-Time PCR

(Reflex to ciprofloxacin resistance by Pyrosequencing)

308 Toxoplasma gondii by Real-Time PCR110 Treponema pallidum (syphilis) by Real-Time PCR320 Ureaplasma urealyticum by Real-Time PCR354 Yersinia species (IgG/IgA) by Western blot (serum required)

VIROLOGY222 Adenovirus by Real-Time PCR207 Cytomegalovirus (CMV) by Real-Time PCR233 CMV IgG/IgM by ELISA (serum required)205 Epstein-Barr virus (EBV) by Real-Time PCR231 EBV-EA-D IgG/IgM by ELISA (serum required)230 EBV-EBNA-1 IgG/IgM by ELISA (serum required)229 EBV-VCA IgG/IgM by ELISA (serum required)267 HBV Subtyping by Pyrosequencing268 HBV Genotyping by Pyrosequencing (Drug Resistance)252 HCV Subtyping by Pyrosequencing* (#250 Req.)262 Hepatitis A virus (HAV) by Real-Time PCR260 Hepatitis B virus (HBV) viral load by Real-Time PCR250 Hepatitis C virus (HCV) viral load by Real-Time PCR220 Hepatitis G virus (HGV) by Real-Time PCR113 Herpes simplex virus (HSV) viral load by Real-Time PCR* (#126 Req.)126 Herpes subtype (HSV-1, HSV-2) by Real-Time PCR257 HSV-1 IgG by ELISA (serum required)258 HSV-2 IgG by ELISA (serum required)254 HIV-1 by Western blot (serum required)253 HIV-1 & 2 by Enzyme Immuno Assay (EIA) (serum required)255 HIV-1 viral load by Real-Time PCR238 Human herpesvirus-6 (HHV-6) IgG by ELISA (serum required)219 Human herpesvirus-6 (HHV-6) Variants A & B by Real-Time PCR263 Human herpesvirus-7 (HHV-7) by Real-Time PCR221 Human herpesvirus-8 (HHV-8) by Real-Time PCR203 Human T-lymphotropic virus I (HTLV-I) by Real-Time PCR223 Parvovirus by Real-Time PCR138 Polyomavirus BK by Real-Time PCR (UroSwab® or blood)139 Polyomavirus JC by Real-Time PCR (UroSwab® or blood)264 St. Louis Encephalitis virus by Real-Time PCR215 Varicella-Zoster virus (VZV) by Real-Time PCR243 West Nile virus by Real-Time PCR244 West Nile virus IgG / IgM by Western blot (serum required)265 Western Equine Encephalitis virus by Real-Time PCR

OTHER TESTS

The federal government requires that physicians only order tests that are medically necessary for the diagnosis and treatment of a patient. MDL offersindividual tests, as well as a limited number of customized panels. Please take care in selecting only those tests that are medically necessary. If you check off apanel as your choice, MDL understands all of the component tests to be medically necessary, and will perform, report and bill for all such component tests.

MYCOLOGY553 Aspergillus fumigatus by Real-Time PCR551 Candida albicans by Real-Time PCR576 Candida dubliniensis by Real-Time PCR559 Candida glabrata by Real-Time PCR578 Candida kefyr by Real-Time PCR566 Candida krusei by Real-Time PCR577 Candida lusitaniae by Real-Time PCR558 Candida parapsilosis by Real-Time PCR557 Candida tropicalis by Real-Time PCR554 Cryptococcus neoformans by Real-Time PCR550 Pneumocystis carinii by Real-Time PCR555 Trichosporon by Qualitative PCR

* This test can only be performed when the test in parenthesis is positive. All tests performed will be billed.

BACTERIOLOGY326 Bartonella bacilliformis by Real-Time PCR325 Bartonella clarridgeiae by Real-Time PCR339 Bartonella elizabethae by Real-Time PCR317 Bartonella henselae by Real-Time PCR342 Bartonella quintana by Real-Time PCR356 Bartonella Species by Real-Time PCR

Bartonella henselae, Bartonella quintana

352 Bordetella pertussis (IgG/IgA) by Western blot (serum required)321 Brucella genus by Qualitative PCR

B. abortus, B. melitensis, B. ovis, B. suis

319 Chlamydophila pneumoniae by Real-Time PCR327 Chlamydophila pneumoniae IgG/IgM by ELISA (serum required)104 Chlamydia subtype by Real-Time PCR C. pneumoniae, C. trachomatis

105 Chlamydia trachomatis by Real-Time PCR310 Helicobacter pylori by Real-Time PCR

(Reflex to clarithromycin resistance by Pyrosequencing)

353 Helicobacter pylori (IgG/IgA) by Western blot (serum required)318 Legionella pneumophila by Real-Time PCR332 Mycoplasma fermentans by Real-Time PCR301 Mycoplasma general by Qualitative PCR129 Mycoplasma genitalium by Real-Time PCR130 Mycoplasma hominis by Real-Time PCR335 Mycoplasma penetrans by Qualitative PCR336 Mycoplasma pneumoniae by Real-Time PCR340 Mycoplasma pneumoniae IgG/IgM by ELISA (serum required)145 Neisseria gonorrhoeae by Real-Time PCR

(Reflex to ciprofloxacin resistance by Pyrosequencing)

308 Toxoplasma gondii by Real-Time PCR110 Treponema pallidum (syphilis) by Real-Time PCR320 Ureaplasma urealyticum by Real-Time PCR354 Yersinia species (IgG/IgA) by Western blot (serum required)

The respiratory tract is susceptible to infection by a variety of bacterial and viral pathogens; the fact that they share similar clinical presentations makes differentiation and diagnosis difficult. Consequently, Medical Diagnostic Laboratories, L.L.C. has designed a series of tests for the determination of respiratory pathogens utilizing the NasoSwab™ collection and transport device. Utilizing the knowledge gained from developing its OneSwab® and UroSwab® methods of patient sampling in clinical diagnostic settings, MDL’s NasoSwab™ represents a less invasive method of sample procurement that utilizes Flocked swab technology.

Respiratory Tract Infections

Pathogen Lavage (%) NasoSwab™ (%)

Human metapneumovirus

13 (13.3) 12 (12.2)

RSV A 15 (15.3) 18 (18.4)

RSV B 0 (0.0) 1 (1.0)

Influenza A 2 (2.0) 2 (2.0)

Influenza B 2 (2.0) 6 (6.0)

B. parapertussis 0 (0.0) 0 (0.0)

B. pertussis 0 (0.0) 0 (0.0)

Table 1. The NasoSwab™ collection method was directly compared to nasal lavage in a blinded study comprised of 98 pediatric patients. Seven real-time PCR assays developed by Medical Diagnostic Laboratories were used in the comparison.

Pathogen determination, when performed, is typically via an invasive and uncomfortable method of nasal lavage, which typically serves as a deterrent for most patients. Development of a less invasive method of sampling led to several generations of nasal swabs, differing in their choice of fibers (1). The clinical utility of these precursors was not proven, however, as their sampling abilities and diagnostic values were consistently out-performed by nasal lavage (1). Some swab variations, particularly calcium alginate, were found to inhibit downstream PCR analyses (2). The Flocked nature and conical shape of the MDL NasoSwab™ addresses this issue. A blinded comparison of NasoSwab™ to nasal lavage collection methods revealed substantial agreement between the two methods following real-time PCR analyses; this data was presented at the 2007 Clinical Virology Symposium in Clearwater, Florida (9) (Table 1).

The 2007 National Vital Statistics Report (4) lists chronic lower respiratory diseases and influenza/pneumonia as the fourth and seventh leading causes of death, respectively, when considering all ages. When analyzed by individual age groups, chronic lower respiratory diseases are within the ten leading causes of death for ages 19 and under and 45 and up, while influenza/pneumonia remains a risk factor for all age groups (4,5). Such statistical studies help define the at-risk populations as infants six months of age and younger, the elderly and adults already diagnosed with a respiratory tract condition, such as Chronic Obstructive Pulmonary Disease (COPD) or asthma. Within these populations, the burden of Respiratory Tract Infections (RTIs) is greater due to the lack or compromise of a fully developed immune system.

From an economic standpoint, lower respiratory tract infections were the seventh most costly malady in 2003, with an estimated $39.5 billion dollars spent on treatment (Figure 1) (3). This cost is subdivided in (Figure 2) to show the absolute value of respiratory illness to an individual family, taking into consideration variables like missed work time along with physician and treatment costs (3). A separate study performed by a community teaching hospital in Illinois reported that the ability to identify the causative agent, whether bacterial or viral, results in significant decreases in the length of patient hospitalizations, patient mortality and antibiotic dispensation (8). When clinical testing included identification of the viral respiratory agent, expenditures were significantly reduced; the average length of a hospital stay was halved, dropping from 10.6 days the previous year to 5.3 days in the year of the study and representing an average savings of almost $6,000 per patient (8).

100. 8

82. 5

45. 4

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C a n c e r

Dia be te s M e l l i tu s

C HD

A rth ri tis

S tro k e

Hy pe rte n s io n

V ira l R T I

C O P D

C HF

O ste o pe ro s is

A sth m a

M ig ra in e

O titis M e dia

A l le rg ic R h in itis

C o st (B i l l io n s US $)

Figure 1. Economic impact of viral RTIs in comparison to other common medical disorders. Adapted from (3).

Figure 2. Economic impact of viral RTIs analysed by individual variables. Adapted from (3).

Considering the physical and economic burdens RTIs present for every age group, identification of the causative agent will allow for more appropriate treatment of patients while at the same time dramatically decreasing a family’s incurred costs. MDL offers the NasoSwab™ as a means of alleviating these burdens. Due to differences in anatomical measurements between the at-risk groups, NasoSwab™ is supplied in two sizes, adult and infant, providing broader applicability. The infant swab was designed with a guard along its shaft regulated to the depth of the infant’s nasal passages to ensure a proper depth is achieved during the swabbing process. Accordingly, the adult swab has a longer shaft (6 cm) to ensure collection of material from the mid-turbinate region. Real-Time PCR assays were developed for the identification of viral and bacterial pathogens capable of infecting the respiratory tract.

Stensballe LG, Trautner S, Kofoed PE, Nante E, Hedegaard K, Jensen IP, Aaby P. Comparison of nasopharyngeal aspirate and nasal swab specimens for detection of respiratory syncytial virus in different settings in a developing country. Trop Med Int Health 2002;7:317-21.Cloud JL, Hymas W, Carroll KC. Impact of nasopharyngeal swab types on detection of Bordetella pertussis by PCR and culture. Journal of Clinical Microbiology 2002;40:3838-40.Fendrick AM, Monto AS, Nightengale B, Sarnes M. The economic burden of non-influenza-related viral respiratory tract infection in the United States. Archives of Internal Medicine 2003;163:487-94.National Vital Statistics Report. Health, United States 2007;55.Winter JH. The scope of lower respiratory tract infection. Infection 1991;19 Suppl 7:S359-64.Greenberg SB. Viral respiratory infections in elderly patients and patients with chronic obstructive pulmonary disease. The American Journal of Medicine 2002;112 Suppl 6A:28S-32S.Brixner DI. Clinical and economic outcomes in the treatment of lower respiratory tract infections. The American Journal of Managed Care 2004;10:S400-7.Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: An outcomes study. Journal of Clinical Microbiology 2000;38:2824-8.Walsh P, Overmyer C, Gofman L, Nguyen T, Michaelson S, Pusavat J, DeSalvia L, Gonzalez D, Feola M, Nguyen KA, Iacono KT, Mordechai E, Adelson ME, Pediatric Respiratory Infectious Disease Analysis: UTM-RT Versus Flocked Swab Nasal Collections. The 23rd Clinical Virology Symposium, Clearwater, Florida, April 29-May 2, 2007.

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References:

FiberSwabs

- Velvet brush-like texture- Improves collection of cell samples- Allows easy elution- 80% of the sample analyte released- Synthetic swab components means no risk of infections or interference- Tailored to fit the nasal anatomy

- Sample entrapment- Release of only 18% to 30% of sample

Flocked Swabs

FiberSwabs

- Velvet brush-like texture- Improves collection of cell samples- Allows easy elution- 80% of the sample analyte released- Synthetic swab components means no risk of infections or interference- Tailored to fit the nasal anatomy

- Sample entrapment- Release of only 18% to 30% of sample

Flocked Swabs

NasoSwab™

Comparison of Flocked Swabs to Fiber Swabs

Pathogen Descriptions

Human Metapneumovirus (hMPV) is an RNA virus that was identified in 2001 as a new respiratory pathogen. The spectrum of symptoms are often indistinguishable from other respiratory infections, especially RSV, and include fever, severe cough, breathing difficulties and wheezing. HMPV is one of four pathogens known to induce bronchiolitis and is estimated to account for 5-15% of all bronchiolitis cases. Instances of severe respiratory distress requiring mechanical ventilation have been associated with hMPV. Infections are very common in the United States and 78% of infections occur between the cooler months of December and April. Standard culture identification is difficult due to the virus’ slow growth making PCR and ELISA more suitable methods of detection.

Human Bocavirus is a DNA virus that was recently identified from respiratory secretions of children with respiratory tract disease. Sequence analysis identified it as a novel parvovirus. Symptoms of infection mimic those resulting from other infections of the respiratory tract, including fever, myalgia, headache, cough and flu-like symptoms. Hospitalization rates due to infection are greatest for populations age five and younger. There is no seasonal prevalence associated with the virus as studies have demonstrated its year-round presence.

Human Coronaviruses are RNA viruses. Though there are many coronaviral strains capable of infecting various mammals, only four human strains have been identified to-date: 229E, OC43, NL-63 and SARS. Coronaviruses are responsible for 10-30% of all common colds and, so far, only the 229E and OC43 strains have been associated with high rates of infection within the United States. Infection occurs across large age groups, though the more severe infections occur among the young and the elderly. Reinfection with the same serotype is quite common, suggesting a short-lived humoral response. Confirmatory tests should exclude standard culturing methods due to the fastidious nature of these viruses.

Bordetella pertussis / Bordetella parapertussis are coccobacilli that cause pharyngitis and Whooping Cough. Bordetella parapertussis, lacking many of B. pertussis’ virulence factors, induces milder forms of disease. Despite their popular association with Whooping Cough, they are not the only pathogenic causes as Bordetella bronchiseptica, Mycoplasma pneumoniae and Chlamydia trachomatis also have pathogenic associations. Once Bordetella infections were considered highly lethal in children and infants, but now vaccination has decreased the major risks associated with infection. However, studies have demonstrated a drop in immunity 3-5 years post-vaccination that reaches undetectable levels within 12 years. Since the 1980’s, the incidence rate has increased cyclically, peaking every 3-4 years. Seasonality is from June through September. Infection is in three stages: catarrhal, paroxysmal, and convalescent. The initial stage, catarrhal, is largely indistinguishable from other common respiratory tract infections, which might be problematic considering it is the most infectious stage.

Moraxella catarrhalis is a gram negative, aerobic, diplococcus clinically associated with bronchitis, sinusitis, laryngitis and otitis media. M. catarrhalis is the third leading cause of otitis media within the United States. Infectious outcome is somewhat age dependent, affecting the upper respiratory tract in children and lower tract in adults. Colonization of children does occur, peaking at age two, but wanes in adulthood. M. catarrhalis is also associated with chronic pulmonary disease in the elderly and long-time smokers and is known to exacerbate chronic obstructive pulmonary disease (COPD). Treatment should not include penicillin as the majority of the isolated organisms demonstrate penicillin resistance.

Group A Streptococcus is a gram positive cocci that can cause strep throat, scarlet fever and rheumatic fever. While anyone is at risk of infection, those with prolonged illnesses, e.g. cancer and diabetes, are at greater risk. The short incubation period (1-3 days) increases the risk of transmission, particularly within institutional settings. Strep infections are very common within the United States, averaging several million total infections annually of which approximately ten thousand progress to more severe, life-threatening, invasive infections. Untreated infections resulting in rheumatic fever can adversely affect both the heart and joints. Penicillin is still considered to be the best form of treatment.

Streptococcus pneumoniae is a gram positive, alpha hemolytic diplococcus that is a major cause of pneumonia, one of the most common causes of death in the United States. Approximately 5-10% of healthy adults and 20-40% of children are colonized with S. pneumoniae and, as a result, can spread it to others through the aerosolization of their respiratory secretions by sneezing and coughing. S. pneumoniae’s polysaccharide coat protects it from phagocytosis and therefore, antibiotic treatments are required. Resistance to multiple antibiotic classes (penicillin, cephalopsporins, macrolides, tetracycline) has been reported. An effective vaccine is available and is recommended for children under the age of two and adults over the age of sixty-five.

Influenza Virus is an RNA virus capable of infecting epithelial cells of the upper respiratory tract. Infection results in the desquamation of the epithelial cells and viral entry into the lungs, which could result in influenza pneumonia. Three infectious strains exist A, B and C, but only A and B strains pose a threat to humans. Infections follow a winter seasonal pattern within the United States. The high degree of mutation and reassortment associated with influenza viruses continually classifies these viruses as a public health issue. Vaccination is highly effective at mitigating the infectious process and is recommended annually for adults age 55 and older. Two vaccine doses are recommended for children who have never been immunized or infected previously. The adamantine class of drugs, including amantadine and ramantadine, have been proven effective at limiting influenza infections; however, adamantine-resistant viral strains have emerged as a result of single point mutations within a key viral gene.

NasoSwab™

MEDICAL DIAGNOSTIC LABORATORIES, L.L.C.Toll Free (877) 269-0090 • www.mdlab.com

Aseptically remove the sterile swab from package, without touching the swab head.

Tilt the patient’s head slightly upwards. Insert the brush end downwards into the nostril all the way to the guard. Be sure to direct the swab down towards the throat and not up towards the forehead. Rotate the swab 360º.

Aseptically remove cap from vial.

Break swab at molded break point and insert into transport medium.

Replace cap to vial. Close tightly.

Fill out vial label with patient information.

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Swab Applicator Instructions

MULTIPLE PATHOGENS

NasoSwab™

Respiratory Syncytial Virus is an RNA virus and is the most common cause of bronchiolitis. Though infections occur throughout life, bronchiolitis is typically limited to the first infection whereby approximately 25-40% of children demonstrate signs and symptoms of bronchiolitis and 0.5-2% require hospitalization. Subsequent infections are limited to moderate-to-severe cold-like symptoms in healthy adults and children but pose a significant health issue to the elderly and those with compromised pulmonary, cardiac, or immune systems. Treatment varies from acetominophen in mild infections to Ribavirin aerosolization in more severe cases.

Chlamydophila pneumoniae is a gram negative bacterium that causes an estimated 2-5 million pneumonia cases a year, 500,000 of which require hospitalization. Incubation can be three to four weeks. Symptoms occur gradually and are typified by little or no fever and, less commonly, laryngitis, pharyngitis and sinusitis. Transmission is via contact with respiratory secretions. The infection manifestations run from asymptomatic to severe. Infections occur in all age groups, though school-aged children are affected more frequently. Incidence rates are higher for males and the elderly.

Mycoplasma pneumoniae is a very small bacterium estimated to cause 15-50% of all pneumonias in adults and an even greater percentage in children. Symptoms typically occur over a one to three week period of time and include headache, fever, sore throat and bronchiolitis. Although there is no seasonality associated with this bacterium, most cases occur during the late summer and fall. Males have a higher incidence of infection than do females. Confirmation of infection by radiological means is effective in only 5-10% of infectious cases.

Adenovirus is capable of infecting membranes of the respiratory, urinary and intestinal tracts, as well as the eyes. Such infections are highly contagious and are estimated to account for approximately 10% of all respiratory tract infections. Children experience the highest infectivity rate and most people will have had at east one adenovirus infection by the age of ten. Symptoms, including fever, flu-like symptoms, swollen glands and cough, resemble bacterial infections and are often treated as such with no clinical benefit. Hospitalization of younger children can occur as a result of dehydration.