quality control for molecular diagnostics 2012 control for molecular diagnostics 2012 eqa programme...

Qual i ty Control for Molecular Diagnost ics

2 0 1 2E Q A P R O G R A M M E

CATALOGUEwww.qcmd.orgVersion number CAT2012/02

V IRALBACTERIALSPECIALISTFUNGAL

PARASIT IC

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Contents

Version number CAT2012/02

Varicella-Zoster virus 2 Enterovirus 2Parechovirus 3Herpes simplex virus 1 & 2 3 JC virus and BK virus 4HIV-1 (DNA) programme A & B 4 B19 Virus 5 Human Herpes Virus 6 5 Human Cytomegalovirus 6 Epstein-Barr virus 6 West Nile Virus 7Dengue Virus 7Cytomegalovirus Dried Blood Spots 8 Human Papillomavirus 8 Adenovirus 9 Influenza A & B virus 9 Human Metapneumovirus 10 Respiratory Syncytial Virus 10 Parainfluenza virus 11 Coronavirus 11Rhinovirus 12 Norovirus 12 EQA Regulatory Range 13 HIV-1 RNA regulatory programme 14 Hepatitis B virus regulatory programme 14 Hepatitis C virus regulatory programme 15 HIV-1 (RNA) Programme A & B 15 Hepatitis B virus programme A & B 16 Hepatitis C virus programme A & B 16

Chlamydia trachomatis programme A & B 17 Chlamydophila pneumoniae and Mycoplasma pneumoniae 17 Legionella pneumophila 18 Methicillin Resistant S. aureus 18 Clostridium difficile 19 Neisseria gonorrhoeae 19 M. tuberculosis Complex 20 Bordetella pertussis 20 Borrelia burgdorferi (Lyme’s Disease) 21

HCV Genotyping 22 HBV Genotyping 22 Methicillin Resistant S. aureus Typing 23 HIV-1 Drug Resistance 23 HIV-1 Drug Resistance (Integrase) 24 Influenza Haemagglutinin Typing 24

Aspergillus 25 Pneumocystis jirovecii pneumonia (PCP) 25

Toxoplasma gondii 26

Hepatitis A virus 27Hepatitis E virus 28Gastroenteritis programmes 29 Viral Gastroenteritis 29 Bacterial Gastroenteritis 30 Parasitic Gastroenteritis 30Candida albicans 31Cytomegalovirus Whole Blood 32 MALDI-TOF Bacterial 32

Bacterial

Specialist

Fungal

Parasitic

New EQA pilot studies

for 2012

Viral

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Viral EQA


Feature SpecificationsNumber of Panel Members 8 to 12

Sample NA Target Source Cultured virus

Matrix panel format Lyophilised Virus Transport Medium (VTM)

Units of Measurement Copies/ml

Panel Member Target Range Covering clinical range

Panel Member Sample Volume 1.0 ml

Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material

Panel Analysis type Qualitative & Quantitative

Panel Testing Evaluated by various molecular methodologies

Storage / Shipment Conditions 2-8°C / Ambient

The human alpha-herpes virus Varicella-Zoster virus (VZV) is the etiological agent for both chicken pox (varicella) and shingles (zoster). Laboratory diagnostics is important for initial determination of VZV infection and distinction between both vaccine and wildtype VZV strains and other viral infections with similar clinical manifestations such as herpes simplex virus (HSV). Detection and quantitation of VZV is also becoming increasingly important in the clinical management of immuno-compromised hosts such as transplant recipients and AIDS patients.

Varicella-Zoster virus DNAVZVDNA12 Catalogue Number QAV034103

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusMatrix panel format Lyophilised Virus Transport Medium (VTM)Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Picornaviridae is a family of important human pathogens affecting millions of people throughout the world. Enteroviruses (EV) form a large genus within this family which also includes the genus parechovirus (PEV). The clinical features of EV infection are often indistinguishable from other infections. It is therefore, essential that a rapid and specific method for the diagnosis and clinical management of acute EV infection is routinely used.

Enterovirus RNAEVRNA12 Catalogue Number QAV984104

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Parechovirus RNAPeVRNA12 Catalogue Number QAV114145

Parechovirus (PEV) is a genus from the Picornaviridae family of viruses. Parechoviruses have been associated with a wide spectrum of disease presentations and are an important cause of severe disease in neonates and young children. The clinical features of PEV infection are often indistinguishable from other (enterovirus) infections. It is therefore, essential that a rapid and specific diagnosis of PEV is made to allow appropriate management of patients.

Herpes simplex virus (HSV) causes a wide spectrum of clinical manifestations in the central nervous system (CNS). The diagnosis and management of HSV infection is a common and increasingly important aspect of clinical practice. Early administration of antiviral drugs is essential for the effective treatment of HSV infection, this has led to a need for more accurate and rapid diagnostic methods. The introduction of nucleic acid amplification technologies (NATs) for the detection of HSV DNA has increased utility for the diagnosis of HSV infection; as well as providing a rapid and more sensitive alternative to other methods.


Herpes simplex virus 1 & 2 DNAHSVDNA12 Catalogue Number QAV994105

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Feature SpecificationsNumber of Panel Members 10 to 12Sample NA Target Source Clinical or Cultured virusMatrix panel format Lyophilised Virus Transport Medium (VTM) or plasmaUnits of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

JC virus and BK virusJCBKDNA12 Catalogue Number QAV074106

The human polyomaviruses JC and BK have a high prevalence in populations throughout the world. JC virus (JCV) and BK virus (BKV) infection is usually completely asymptomatic and can result in a lifelong latent infection in renal tissues and in B lymphocytes. The situation in those with compromised immune systems such as AIDS patients and organ transplant recipients is much more serious with polyomavirus-related disease recognised as an important cause of mortality and morbidity in these groups. It is, therefore, essential that early accurate diagnosis of active JCV/BKV infection is performed which will not only allow pre-emptive treatment of infection but can increase the selectivity of antiviral therapy so reducing drug side-effects.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured proviral cellsMatrix panel format Frozen PBMC in bufferUnits of Measurement DNA Copies/SamplePanel Member Target Range Covering clinical rangePanel Member Sample Volume 0.1 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

HIV-1 DNAHIVDNA12A & HIVDNA12B Catalogue Number QAV034114Human Immunodeficiency Virus Type 1 (HIV-1) infection remains a significant healthcare problem throughout the world. This problem is perpetuated by vertical transmission of HIV-1 from mother to child which in some areas can reach rates of up to 60% of the 25% of pregnant mothers infected with HIV-1. One of the current challenges is the detection of low levels of HIV-1 proviral DNA to allow investigation of vertical transmission of HIV-1 to assess therapeutic interventions aimed at reducing this transmission and in general, to monitor the pathophysiological dynamics of HIV-1 infection. Studies have also shown that HIV-1 proviral DNA persists even after prolonged treatment and can replenish and revive viral infection upon activation. Therefore, early quantification of HIV-1 proviral DNA infection by HIV-1 DNA Nucleic Acid Technologies (NAT) is essential in the effective treatment of HIV.

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B19 virus is a widespread virus causing a variety of diseases in humans that range greatly in severity. The situation in persons with compromised immune systems such as AIDS patients and organ transplant recipients can be serious, with B19 virus recognised as an important viral pathogen causing increased rates of mortality and morbidity in these groups. Antiviral drug treatment in the early stages of active B19 virus infection may effectively ameliorate the risk of life threatening disease. It is, therefore, essential that early accurate diagnosis is performed which will not only allow pre-emptive treatment of infection but can increase the selectivity of antiviral therapy so reducing drug side-effects. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude active B19 virus infection. As a result, these tests are now of great practical and clinical relevance.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical virusMatrix panel format Frozen PlasmaUnits of Measurement IU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

B19 virusB19DNA12 Catalogue Number QAV034116

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusGenotypic Variant Subtypes A and BMatrix panel format Lyophilised Plasma or Virus Transport Medium (VTM)Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Human Herpes Virus 6 DNAHHV6DNA12 Catalogue Number QAV084119Human Herpes virus 6 (HHV-6) is one of the most widespread human beta-herpes viruses. HHV-6 is associated with a number of childhood diseases resulting in the majority of the population being seropositive for HHV-6 before adulthood. Immunosupression in an individual can lead to reactivation of the virus and associated sequelae. Early detection of HHV-6 is crucial for effective treatment and immunosuppressive drug therapy amendment which may result in proliferative disease regression. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude active HHV-6 infection. As a result, these tests have become of great practical and clinical relevance.

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Cytomegalovirus (CMV) is a beta herpes virus with a high prevalence (40-80%) in populations throughout the developed world. CMV is normally a latent lifelong infection that is completely asymptomatic in those infected with the virus.The situation in persons with compromised immune systems such as AIDS patients and organ transplant recipients is much more serious with CMV recognised as one of the most important viral pathogens causing high rates of mortality and morbidity in these groups. Antiviral drug treatment in the early stages of active CMV infection may effectively ameliorate the risk of life threatening disseminated CMV disease. It is, therefore, essential that early accurate diagnosis is performed which will not only allow pre-emptive treatment of infection but can increase the selectivity of antiviral therapy so reducing drug side-effects. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude active CMV infection. As a result, these tests are now of great practical and clinical relevance.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virus

Matrix panel format Lyophilised Plasma, Virus Transport Medium (VTM)

Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Human Cytomegalovirus DNACMVDNA12 Catalogue Number QAV014120

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusMatrix panel format Lyophilised Plasma, Virus Transport Medium (VTM)Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Epstein-Barr virus DNAEBVDNA12 Catalogue Number QAV024121Epstein-Barr virus is a widespread human gamma-herpes virus that is associated with a broad spectrum of epithilio- and lympho-proliferative disorders which are an important cause of mortality and morbidity especially in immuno-compromised hosts such as transplant recipients and AIDS patients. Early detection of EBV is crucial for effective treatment and immunosuppressive drug therapy amendment which may result in proliferative disease regression. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude active EBV infection. As a result, these tests have become of great practical and clinical relevance.

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West Nile virus (WNV) is part of the Japanese encephalitis virus group of flaviviruses. WNV is an arthropod borne virus which cycles between insect and vertebrate hosts causing mild flu-like symptoms to clinical encephalitis in the human population. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude WNV infection. As a result, these tests are now of great practical and clinical relevance.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured VirusMatrix panel format Lyophilised Virus Transport Medium (VTM)Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

West Nile Virus RNAWNVRNA12 Catalogue Number QAV104141

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured VirusMatrix panel format Lyophilised Virus Transport Medium (VTM)Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Dengue virus (DENV) belongs to the flavivirus group of viruses and is an important arthropod borne virus infecting humans. DENV infection can range from asymtomatic to the severe Dengue heamorrhagic fever (DHF) or Dengue shock syndrome (DSS). The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude DENV infection and determine the serotype of the virus involved. As a result, these tests are now of great practical and clinical relevance.

Dengue virus RNADENVRNA12 Catalogue Number QAV114148

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Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virus and clinical materialMatrix panel format Whole blood on DBS collection cardUnits of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Sample Pre-treatment Requirement DNA extraction from dried blood spotPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions Ambient

Cytomegalovirus Dried Blood SpotsCMVDBS12 Catalogue Number QAV064127

Cytomegalovirus (CMV) is a highly prevalent congenital infectious agent throughout the developed world. The clinical consequences of infection may be present at birth or manifest themselves during childhood. It is essential that early accurate diagnosis of infected neonates is performed, not only to allow clinical treatment of infection but also to facilitate prompt recognition of sequelae during monitoring. Dried blood spots (DBS) are routinely collected at birth for metabolic and genetic screening. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can detect CMV in a variety of sample types including DBS. As a result, these tests are now of great practical and clinical relevance.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusMatrix panel format Clinically relevant or transport mediumPanel Member Target Range Covering clinical rangePanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Human Papillomavirus DNAHPVDNA12 Catalogue Number QAV094130

Human Papillomavirus (HPV) infection has been detected in over 95% of cervical cancers, the second most common cancer detected in females worldwide. The detection of HPV infections is an important part of the triage with cytomorphological examination in the early detection of cervical cancer in scrapings. For the detection in triage both the quantitative, clinical relevant sensitivity as well as accurate HPV-typing are essential. The introduction of nucleic acid amplification technologies (NAT) and nucleic acid hybridisation assays has led to the development of sensitive, type specific diagnostic tests that can rapidly identify HPV infection. As a result, these tests are now of great practical and clinical relevance.

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Viral EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusMatrix panel format Frozen Virus Transport Medium (VTM)Units of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Adenovirus DNAADVDNA12 Catalogue Number QAV054133

Human adenovirus (AdV) is a widespread genus of human viruses associated with a broad spectrum of infectious diseases. Adenoviruses are also an important cause of mortality and morbidity in immunocompromised hosts especially allogeneic bone marrow and stem cell transplant recipients. Early detection of AdV is crucial for effective treatment and immunosuppressive drug therapy amendment in such patients. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude AdV infection. As a result, these tests have become of great practical and clinical relevance.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusMatrix panel format Frozen Virus Transport Medium (VTM)Panel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Influenza A & B virus RNAINFRNA12 Catalogue Number QAV054134

Influenza virus (InfV) is an important cause of mortality and morbidity throughout the world especially in the elderly and those with other respiratory complications. Early detection of InfV is crucial for effective treatment and immunosuppressive drug therapy amendment in such patients. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude InfV infection. As a result, these tests have become of great practical and clinical relevance.

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Human MetapneumovirusMPV12 Catalogue Number QAV054135

Human metapneumovirus (hMPV) is a commonly occurring viral pathogen responsible for respiratory infection particularly in the young and elderly as well as those with underlying immunological and respiratory complications. Early detection of hMPV is crucial for effective treatment and immunosuppressive drug therapy amendment. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude hMPV infection. As a result, these tests have become of great practical and clinical relevance.


Respiratory Syncytial virusRSV12 Catalogue Number QAV054142

Human respiratory syncytial virus (RSV) is an important cause of mortality and morbidity in young children, the elderly and immuno-compromised hosts, as well as those with underlying respiratory complications. Early detection of RSV is crucial for effective treatment and immunosuppressive drug therapy amendment in such patients The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude RSV infection. As a result, these tests have become of great practical and clinical relevance.

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Parainfluenza virus RNAPINFRNA12 Catalogue Number QAV064136

Parainfluenza virus (PIV) is an important cause of upper and lower respiratory tract disease especially in infants and immunocompromised hosts. PIV can be divided into four genetically and antigenically different types which are associated with severity and clinical importance of the PIV infection. The use of classic diagnostic methods such as viral isolation and serology can results in delays of several weeks before results are available. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude PIV infection. As a result, these tests are becoming of great practical and clinical relevance.


Coronavirus RNACVRNA12 Catalogue Number QAV064137Human coronavirus (CV) is one of the major causes of common cold infections throughout the world. CV can also cause more severe respiratory infections especially in young children, the elderly and immuno-compromised hosts. Early detection of CV infection is essential in these at risk groups to allow effective treatment and drug therapy amendment. Viral culture is still the main method for laboratory diagnosis of respiratory infections. The introduction of nucleic acid amplification technologies (NAT) has led to the development of much more sensitive diagnostic tests that can rapidly confirm or exclude CV infection. As a result, these tests have become of great practical and clinical importance.

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Rhinovirus RNARVRNA12 Catalogue Number QAV064143

Rhinovirus (RV) is one of the major causes of common cold infections and is an important cause of more severe infection in at risk groups.The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude RV infection. As a result, these tests are now of great practical and clinical relevance in the effective treatment of patients.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured whole virus or RNA TranscriptsMatrix panel format Frozen Virus Transport Medium (VTM) or bufferPanel Member Sample Volume 1.0ml VTM, 0.1ml BufferPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical or semi-processed samplesPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Norovirus RNANVRNA12 Catalogue Number QAV084139Norovirus (NV) is a single stranded RNA virus of the family caliciviridae. NV is one of the most important causes of non-bacterial acute gastroenteritis in humans. The stability of NV in the environment, multiple routes of transmission and very low infectious dose all contribute to the high impact of NV outbreaks. It is therefore important that NV infection is quickly identified to allow rapid intervention and isolation to prevent further spread of the virus. The use of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly identify NV infection. As a result, these tests are now of great practical and clinical relevance.

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EQA Regulatory Range

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The frequency of challenge within an annual EQA survey varies considerably between different EQA providers and the types of EQA schemes they offer. In general the number of EQA distributions or challenges within a calendar year is driven by professional opinion, both scientific and clinical. Key factors include the number of tests the laboratory performs per year; pathogen prevalence; and the range & complexity of tests used. In addition, the EQA provider also has to consider the different needs of the national regulatory agencies and accreditation bodies which sometimes set the minimum number of challenges per year. In response to these requirements QCMD has established the regulatory EQA programmes for HIV, HBV and HCV viral load in order to further support individual laboratory’s local regulatory requirements. The regulatory programme format will comprise of four challenges per year. Two full EQA panels (8-10 panel members) and two core EQA panels consisting of 4 panel members. The focus of the programmes is on quantitative detection and following each EQA challenge ‘on-line’ reporting will enable participating laboratories to monitor their cumulative performance over time. On completion of the four challenges, laboratories will be provided with an annual summary report. The report will provide an overview of the laboratories annual performance, a cumulative score for the annual EQA, participant trend analysis (continued in future participant rounds), and where appropriate, feedback aimed at supporting quality improvement in line with the laboratories regulatory requirements.

For further information download the Regulatory EQA manual through your profile area

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Viral EQA


Feature SpecificationsNumber of Panel Members 2 full EQA (8 to 10 panel members), 2 core EQA (4 panel members) Sample NA Target Source Cultured virus or Clinical materialMatrix panel format Frozen PlasmaUnits of Measurement IU/ml, Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

HIV-1 RNA regulatory programmeHIVRNAReg12 Catalogue Number QAS124158

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Feature SpecificationsNumber of Panel Members 2 full EQA (8 to 10 panel members), 2 core EQA (4 panel members) Sample NA Target Source Clinical materialMatrix panel format Frozen PlasmaUnits of Measurement IU/ml, Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Hepatitis B virus regulatory programmeHBVDNAReg12 Catalogue Number QAS124159

HIV nucleic acid viral load measurement is used to diagnose, predict, and monitor disease progression and has become a primary healthcare parameter for disease management. The risks of developing AIDS and the link between HIV viral load is well documented and maintaining low viral loads through antiretroviral therapy (ART) is essential as it slows disease progression, reduces the risk of complications and ultimately prolongs patient life. Therefore the accurate measurement of HIV viral load during treatment is essential as changes in viral load during treatment can also indicate the development of resistance to the antiretroviral therapy. Within clinical practice Copies/ml has become the common unitage for the reporting of HIV viral loads. However with the introduction of the WHO International Standard commercial HIV viral load test manufacturers generally express their results in IU/ml and provide a method / technology specific conversion factor where appropriate. The HIV regulatory EQA programme allows the laboratory to independently assess their laboratory procedure and viral load assay through the year and supports the laboratory’s requirements in line with ISO15189 or equivalent.

With the increased availability of approved HBV treatment options over the last 10 years, HBV viral load determination has become an important clinical tool in the diagnosis and monitoring of disease. In chronically infected individuals HBV viral loads can cover large clinical ranges (zero to 1010 copies/ml of HBV-DNA) in serum / plasma samples. As the aim of HBV therapy is to treat until the virus is at an undetectable level, it is essential that the viral load assay is capable of detecting very low levels of the HBV virus. In contrast, it is also important for the viral load assay to be able to quantify high levels of virus (over 100 million IU/ml) as this provides an indication for further treatment or potential drug resistance. Therefore current molecular assays for the detection of HBV need to be able to provide robust and repeatable results over a large dynamic assay range. This can impact on the accuracy of the quantitative result especially the low and upper limit of detections of the assay and with different genotypes. Hence appropriate quality control and quality assessment is essential in the routine laboratory for the management, maintenance, and improvement of assay performance. The HBV regulatory EQA programme allows the laboratory to independently assess their laboratory procedure and viral load assay through the year and supports the laboratory’s requirements in line with ISO15189 or equivalent.

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Viral EQA

Version number CAT2012/02 15

Feature SpecificationsNumber of Panel Members 2 full EQA (8 to 10 panel members), 2 core EQA (4 panel members) Sample NA Target Source Clinical materialMatrix panel format Frozen PlasmaUnits of Measurement IU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Hepatitis C virus regulatory programmeHCVRNAReg12 Catalogue Number QAS124149

Recent breakthroughs have significantly contributed to the care and therapy of the estimated over 50 million people living with HIV/AIDS throughout the world. Clinical management of Human Immunodeficiency Virus Type 1 (HIV-1) infection relies heavily on the direct detection and quantification of HIV-1 RNA in plasma or serum to evaluate viraemia at all stages of viral infection and antiviral therapy. Studies have shown that HIV-1 may be more vulnerable to antiviral treatment during primary infection prior to the development of HIV-1 antibodies, therefore early detection and diagnosis is essential in the effective treatment and continued disease management of HIV infection.

Feature SpecificationsNumber of Panel Members 8 to 10Sample NA Target Source Cultured virus or Clinical materialMatrix panel format Frozen PlasmaUnits of Measurement IU/ml, Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

HIV-1 RNAHIVRNA12A & HIVRNA12B Catalogue Number QAV994108

HCV Viral Load determination is primarily used for the diagnosis, monitoring, and clinical management of disease, before, during, and after therapy. Following diagnosis and before treatment a viral load test will normally be performed in order to establish a baseline value. This is used in order to define the appropriate treatment rationale. Viral load measurements will then be taken at regular intervals during therapy in order to gauge efficacy and determine treatment duration. Viral load may be taken periodically after treatment in order to monitor for relapse. The limits of detection (LOD) vary significantly dependant on the platform technology and specific types of quantitative molecular tests have reportable LOD down to 50 IU/ml. Hence assay sensitivity is an important parameter when determining the completion of therapy and also when testing Human blood bank products. Genotype specificity can also influence the viral load with some HCV assays resulting in under-quantitation. The common unit of measurement is IU/ml and manufacturers calibrate their tests to the HCV WHO International Standard. The HCV regulatory EQA programme allows the laboratory to independently assess their laboratory procedure and viral load assay through the year and supports the laboratory’s requirements in line with ISO15189 or equivalent.

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Viral EQA


Feature SpecificationsNumber of Panel Members 8 to 10Sample NA Target Source Clinical materialMatrix panel format Frozen PlasmaUnits of Measurement IU/ml, Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Hepatitis B virus DNAHBVDNA12A & HBVDNA12B Catalogue Number QAV994110

The prevalence of Hepatitis B (HBV) infection varies considerably across the world. It is estimated that 350 million people are infected with hepatitis B worldwide, with 50 million new cases diagnosed every year. The course of chronic HBV infection is highly variable, therefore rapid detection and diagnosis of HBV infection is essential in controlling not only spread of disease, but also the severe sequelae. Direct detection and quantitation of HBV in plasma or serum is now routinely performed to detect and evaluate viremia in infected persons; to identify infectious chronic carriers; and to predict and monitor the efficacy of antiviral therapy.

Due to the extremely low concentration of virus found in Hepatitis C Virus (HCV) infected individuals, direct detection and quantitation of HCV RNA in plasma is now the “gold standard” for detection of viraemia; to identify infectious chronic carriers; and to predict and monitor the efficacy of antiviral therapy. HCV RNA detection allows HCV infection to be diagnosed in early acute disease prior to antibody detection or aminotransferase evaluation, and in immunocompromised individuals who fail to generate specific antibodies. Rapid detection and diagnosis is not only critical in controlling the devastating sequelae of HCV infection but also spread of the disease.

Feature SpecificationsNumber of Panel Members 8 to 10Sample NA Target Source Clinical materialMatrix panel format Frozen PlasmaUnits of Measurement IU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Hepatitis C virus RNAHCVRNA12A & HCVRNA12B Catalogue Number QAV994112

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Bacterial EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured bacteriaMatrix panel format Lyophilised Urine or Physiological BufferUnits of Measurement Copies/vialPanel Member Target Range Covering clinical rangePanel Member Sample Volume Dependent on platformPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Chlamydia trachomatis (Ct) is one of the most widespread bacterial sexually transmitted diseases (STD) throughout the world. However, many of the conventional detection techniques lack sensitivity and specificity for accurate diagnosis, especially in asymptomatic infected individuals. This has led to a need for more accurate and rapid diagnostic methods. The introduction of nucleic acid amplification technologies (NATs) has increased utility for the diagnosis of infection; as well as providing a rapid and more sensitive alternative to the conventional methods.

Chlamydia trachomatisCTDNA12A & CTDNA12B Catalogue Number QAB004101

Feature SpecificationsNumber of Panel Members 10 to 12Sample NA Target Source Cultured bacteriaMatrix panel format Lyophilised bronchoalveolar lavage (BAL) or sample transport medium (STM)Panel Member Target Range Covering clinical rangePanel Member Sample Volume 0.5 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Chlamydophila pneumoniae (Cp) and Mycoplasma pneumoniae (Mp) are atypical bacterial pathogens involved in a significant proportion of respiratory tract infections throughout the world. It is important that accurate diagnosis of Cp and Mp infection is performed to allow effective treatment of infection. Serological diagnosis of Cp and Mp involves complex and time consuming procedures. The introduction of nucleic acid amplification technologies (NAT) has led to the development of fast, sensitive diagnostic tests that can rapidly confirm or exclude Cp/ Mp infection. As a result, these tests are now of great practical and clinical relevance.

Chlamydophila pneumoniae & Mycoplasma pneumoniaeCP.MP12 Catalogue Number QAB084107

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Bacterial EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured bacteriaMatrix panel format Bronchoalveolar lavage (BAL) or physiological solutionUnits of Measurement GEq/ml, CFU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 0.5 mlPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Legionella pneumophila (LP) is responsible for 90% of legionellosis cases and is one of the leading causes of bacterial pneumonia, particularly in elderly and immunocompromised individuals, among whom mortality may exceed 30%. Prognosis of patients depends in part on the rapid identification of the causative agent. However, conventional diagnostic methods have shown limited sensitivity and specificity. Serological methods are inadequate for rapid diagnosis of acute legionellosis due to the absence of seroconversion during the acute phase of the disease. For these reasons, nucleic acid amplification techniques (NATs) are attractive tools for detection of Legionella species in clinical as well as environmental samples.

Legionella pneumophilaLPDNA12 Catalogue Number QAB044122

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Inactivated cultured MRSAMatrix panel format Culture MediumUnits of Measurement CFU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Methicillin-Resistant S. aureus (MRSA) is a nosocomial pathogen causing a range of conditions of varying severity. The recent dissemination of MRSA into the wider community has further heightened concerns over the spread of this pathogen. Infection control measures within hospitals have been demonstrated to greatly reduce the spread of infection, this depends in part on the rapid identification of MRSA. However, conventional diagnostic methods take a long period to identify MRSA. Nucleic acid amplification techniques (NATs) can quickly and accurately identify MRSA in a variety of samples and are quickly becoming a routine method for the clinical laboratory detection of MRSA.

Methicillin Resistant S. aureus DNAMRSADNA12 Catalogue Number QAB064124

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Bacterial EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured bacteriaMatrix panel format Lyophilised culture mediumUnits of Measurement CFU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Clostridium difficile (C.diff) is a Gram positive anaerobic bacteria that can cause a range of diseases including pseudomembranous colitis. The situation in elderly persons is much more serious with C.diff recognised as one of the most important gastrointestinal pathogens in this group. Nosocomial infections are most common because of the use of broad spectrum antibiotics that modify the normal gut microflora and increase the chances of C.difficile Associated Disease (CDAD) developing. Accurate and rapid diagnosis is crucial so that medical personnel can isolate and treat patients as early as possible.

Clostridium difficile DNACDDNA12 Catalogue Number QAB084125

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured bacteriaMatrix panel format Lyophilised UrineUnits of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume Dependent on platform

Panel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Neisseria gonorrhoeae (Ng) is one of the most widespread bacterial sexually transmitted diseases (STD) throughout the world. However, many of the conventional detection techniques lack sensitivity and specificity for accurate diagnosis, especially in asymptomatic infected individuals. This has led to a need for more accurate and rapid diagnostic methods. The introduction of nucleic acid amplification technologies (NATs) has increased utility for the diagnosis of infection; as well as providing a rapid and more sensitive alternative to conventional methods.

Neisseria gonorrhoeae DNANgDNA12 Catalogue Number QAB034126

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Bacterial EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured Mycobacteria tuberculosis Complex (BCG)Matrix panel format Sputum or protein rich bufferPanel Member Target Range Covering clinical rangePanel Member Sample Volume 0.25 mlPanel Sample Pre-treatment Requirement Routine respiratory sample treatmentPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Tuberculosis remains the single greatest cause of mortality due to an infectious agent worldwide. The introduction of nucleic acid amplification technologies (NAT) has led to the development of rapid, specific and sensitive diagnostic tests that can rapidly confirm or exclude Mycobacterium tuberculosis (Mtb) infection. As a result, these tests have become of great practical and clinical relevance.

M. tuberculosis ComplexMTBDNA12 Catalogue Number QAB014129

Whooping cough is caused by the bacterium Bordetella pertussis (BP) infection. Although it is now recognised as a relatively mild disease in adults, there remains a significant mortality rate in infants and immunocompromised patients. Effective immunisation has helped in the control of the disease; however rapid diagnosis of infection is crucial in the treatment of infection. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive, type specific diagnostic tests that can rapidly identify BP infection. As a result, these tests are now of great practical and clinical relevance.

Bordetella pertussisBPDNA12 Catalogue Number QAB094132

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured bacteriaMatrix panel format Physiological solutionUnits of Measurement CFU/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

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Bacterial EQA


Borrelia burgdorferiBbDNA12 Catalogue Number QAB114147

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured / Clinical materialMatrix panel format Culture MediumPanel Member Target Range Covering clinical rangePanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Lyme borreliosis, caused by the spirochete Borrelia burgdorferi (Bp), is one of the fastest spreading diseases particularly in Europe and the USA. Early treatment of Bp infection can quickly and successfully be treated with oral antibiotics. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can confirm or exclude the presence Bp at the early stages infection. As a result, these tests have become of great practical and clinical relevance.

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Specialist EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical materialGenotypic Variant Various HCV subtypesMatrix panel format Frozen PlasmaPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Molecular typingPanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Hepatitis C virus (HCV) is the major cause of Hepatitis worldwide. HCV is an enveloped positive single stranded RNA virus of approximately 9400 nucleotides and, like other RNA viruses, is characterised by a high degree of genetic heterogeneity. It is now evident that HCV genotype has a significant influence on disease outcome and response to anti-viral therapy. Therefore, the typing of HCV to identify its genotype has become increasingly important in the patient management of HCV infected individuals.

HCV GenotypingHCVGT12 Catalogue Number QAS034117

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical materialGenotypic Variant Various HBV subtypesMatrix panel format Frozen PlasmaPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Molecular typingPanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

It is estimated that 350 million people are infected with Hepatitis B worldwide, with 50 million new cases diagnosed every year. The course of chronic Hepatitis B infection is highly variable and it is becoming evident that HBV genotype has an influence on disease outcome and response to anti-viral therapy. Therefore, the typing of HBV to identify its genotype has become increasingly important in the patient management of HBV infected individuals.

HBV GenotypingHBVGT12 Catalogue Number QAS064118

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Specialist EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured MRSA strainsMatrix panel format Culture MediumPanel Member Target Range Genetic variants of S. aureusPanel Member Sample Volume 0.2 mlPanel Sample Pre-treatment Requirement Culture followed by standard NA extractionPanel Analysis type Molecular typingPanel Testing Evaluated by various methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Methicillin Resistant S. aureus TypingMRSATP12 Catalogue Number QAS074128

Methicillin-Resistant S. aureus (MRSA) is a nosocomial pathogen causing a range of conditions of varying severity. The recent dissemination of MRSA into the wider community has increased concerns over the spread of this pathogen. MRSA surveillance measures have been integral to monitoring the spread of antimicrobial resistance within the community, this depends in part on the rapid and accurate typing of MRSA. Molecular-based typing methods can quickly and accurately genotype MRSA in a variety of samples and are quickly becoming the method of choice for MRSA outbreak analysis.

Feature SpecificationsNumber of Panel Members 4 to 7Sample NA Target Source Cultured virus or Clinical materialMatrix panel format Lyophilised PlasmaPanel Member Target Range Various mutations - Reverse Transcriptase (RT) and Protease (PR) genesPanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type SequencingPanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Antiviral therapy that targets the reverse transcriptase (RT) and protease (Pro) genes within human immunodeficiency virus type 1 (HIV-1) is now a routine part of the patient management of HIV-1 infection. Unfortunately viral mutations have allowed the generation of HIV-1 strains that are less sensitive to antiviral drug therapies. As a result the rapid genotyping of HIV-1 RT and Pro genes in plasma has become an integral part of the management of HIV-1 antiviral drug therapy for infected individuals.Genotyping HIV-1 RT and Pro genes allows the determination of base-line HIV-1 RT and Pro genotype before and during drug therapy and provides information with which to identify, implement and modify rational drug regimes for the treatment of infected individuals. HIV genotyping compliments standard HIV diagnosis by providing additional information on a patient’s disease status thus allowing the clinician to differentiate between resistance caused by viral mutation and other potential sources of increased HIV viral load.

HIV-1 Drug ResistanceENVA12 Catalogue Number QAV024131

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Specialist EQA


Feature SpecificationsNumber of Panel Members 4 to 7Sample NA Target Source Cultured virus or Clinical materialMatrix panel format Lyophilised PlasmaPanel Member Target Range Various mutations - Integrase (INT) genePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type SequencingPanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

HIV-1 Drug Resistance (Integrase)ENVAINT12 Catalogue Number QAV114146

Integrase inhibitors that target the intergase (INT) within human immunodeficiency virus type 1 (HIV-1) are now a routine part of the patient management of HIV-1 infection. Unfortunately viral mutations have allowed the generation of HIV-1 strains that are less sensitive to antiviral drug therapies. As a result, the rapid genotyping of HIV-1 integrase genes in plasma has become part of the management of HIV-1 antiviral drug therapy for infected individuals. Genotyping the HIV-1 INT gene allows the determination of base-line HIV-1 INT genotype before and during drug therapy and provides information with which to identify, implement and modify rational drug regimes for the treatment of infected individuals. HIV genotyping compliments standard HIV diagnosis by providing additional information on a patient’s disease status thus allowing the clinician to differentiate between resistance caused by viral mutation and other potential sources of increased HIV viral load.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured virusMatrix panel format Frozen Virus Transport Meduim (VTM)Panel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Molecular typingPanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Influenza Haemagglutinin TypingINFHT12 Catalogue Number QAS064138

Influenza virus (InfV) is a highly contagious acute respiratory disease that can spread rapidly and widely causing high levels of mortality and morbidity. The segmented nature of the influenza genome makes genomic reassortment an important mechanism for generating genetic diversity. This process is particularly important in Influenza A virus because of its role in the generation of new pandemic strains of the virus. Early detection and typing of viral strains is of great importance for the effective treatment and monitoring of influenza outbreaks. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive tests that can rapidly identify the particular strain of virus. As a result, these tests are becoming of great practical and clinical relevance.

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Fungal EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured / Clinical / Purified Nucleic AcidMatrix panel format Saline solutionPanel Member Target Range Covering clinical rangePanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Aspergillus DNAASPDNA12 Catalogue Number QAF104140

The diagnosis of invasive aspergillosis is challenging because the symptoms are often non-descript and classical mycological methods do not always detect the pathogen. Those most at risk of invasive aspergillosis are those with compromised immune systems such as AIDS patients and organ transplant recipients. Nucleic acid amplification techniques (NATs) are attractive tools for detection of Aspergillus species in clinical samples. However a lack of standardisation has hindered widespread acceptance.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured / Clinical materialMatrix panel format Physiological solutionPanel Member Target Range Covering clinical rangePanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Pneumocystis jirovecii pneumonia (PCP) PCPDNA12 Catalogue Number QAF114144

Pneumocystis pneumonia (PCP) is a common opportunistic infection associated with mortality and morbidity especially in immuno-compromised hosts such as transplant recipients and AIDS patients. Early detection of PCP is crucial for effective treatment and immunosuppressive drug therapy amendment which may result in proliferative disease regression. The introduction of nucleic acid amplification technologies (NAT) has led to the development of sensitive diagnostic tests that can rapidly confirm or exclude active PCP infection. As a result, these tests have become of great practical and clinical relevance.

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Parasitic EQA


Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Cultured T. gondiiMatrix panel format Lyophilised amniotic fluid or plasmaUnits of Measurement Tg /mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 2.0 mlPanel Sample Pre-treatment Requirement Reconstitution of lyophilised materialPanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions 2-8°C / Ambient

Toxoplasma gondii DNATGDNA12 Catalogue Number QAF044123

Toxoplasma gondii (TG) is an obligate intracellular parasite that is a leading cause of serious infection in susceptible groups such as immunocompromised individuals, transplant patients and pregnant mothers. Prognosis of patients depends in part on the rapid identification of TG infection. However, conventional diagnostic methods have shown limited sensitivity and specificity and serological methods are inadequate for rapid diagnosis due to the absence of seroconversion during the early phase TG infection. For these reasons, nucleic acid amplification techniques (NATs) are attractive tools for detection of TG in a variety of clinical samples.

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New EQA pilot Studies for 2012


Hepatitis A virusHAVRNA12 Catalogue Number QAV124156

Hepatitis A virus (HAV) is a major public health concern due to its epidemiology and it is estimated that tens of millions of individuals are infected with the virus each year. Infection rates are highest within developing countries particularly in regions associated with poor hygiene due to persistent circulation of the virus in the environment. In contrast, HAV infection within developed countries is generally associated with travel to regions with a high incidence of the disease. Vaccination programs have proven successful, but HAV outbreaks remain a global cause of public health, environmental, and economic concern. The HAV is a single stranded RNA virus known to cause liver disease. Although there has only been one serotype of HAV described, genetically the virus has been classified into seven different HAV genotypes. These are designated I to VII. Genotypes I, II, III and VII are associated with human disease, with genotypes I and III considered the most prevalent, and comprising at least 80% of circulating human strains. In addition, genotypes I and III can be further divided into subtypes A and B. HAV can be spread through the direct contact with an infectious individual. However it is primarily spread indirectly via the fecal-oral route and transmitted by the ingestion of contaminated water supplies or the consumption of raw or undercooked food such as shellfish. Molecular techniques have emerged as important diagnostic and monitoring tools within the clinical and environmental setting because of their rapidity, accuracy and sensitivity. A HAV WHO International Standard was introduced in 2007 to allow the calibration of secondary reference materials, support the validation of molecular diagnostic assays, and improve quantification of the virus in the clinical laboratory and within the blood product, IVD manufacturers setting. The primary aim of this HAV EQA pilot study is to evaluate the ability of laboratory in the detection of HAV and investigate comparative molecular quantification in terms of sensitivity and specificity within the clinical context.

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical / CulturedMatrix panel format Plasma / clinically relevant matricesUnits of Measurement IU/ml, Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

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Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical / CulturedMatrix panel format PlasmaUnits of Measurement Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.2 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Hepatitis E virusHEVRNA12 Catalogue Number QAV124157

Hepatitis E virus (HEV) is a single stranded RNA virus belonging to the family of Hepeviridae. This non-enveloped virus behaves in a similar way to Hepatitis A virus and transmission is by the fecal-oral route. There are currently 4 genotypes HEV known (genotypes 1 to 4) Genotype 1 and 2 are related to human disease, while the genotypes 3 and 4 are more generally associated with animal disease, particularly porcine. Genotype 1, 2 and 4 are often prevalent in areas associated with poor hygiene. Recently there have been a number of large human epidemics described in the literature where genotype 1 has been associated with high mortality in pregnant women. In addition, infections with genotype 1 or 2 are mostly travel-related to endemic areas. The genotype 3 has become of increasing interest in recent publications since it may be an important factor in transplant patients with chronic infection or other immunosuppressed patients. In addition, genotype 3 HEV infections have been documented in patients with haematological disorders. At present serological assays are of limited use in the detection of genotype 3 as they predominantly detect genotype 1 and 2 HEV infections. Hence molecular detection and strain determination is becoming an important aspect in the diagnosis and monitoring of HEV infection. The primary goal of this HEV EQA pilot study is to evaluate the ability of laboratories in the detection of the different HEV genotypes and where appropriate investigate the comparative quantitative detection in view of the first WHO International standard and developing treatment options.

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Gastroenteritis can be caused by a wide variety of bacteria, viruses and parasites. It is often associated by severe inflammation of the gastrointestinal tract involving both the stomach and small intestine. This results in acute diarrhoea and vomiting. Diagnosis is primarily based on clinical symptoms, but laboratory diagnosis on the etiological cause is often needed to provide optimal patient care and to take preventive measures. In recent years Molecular Diagnostic techniques such as real-time PCR have also been introduced for the laboratory diagnosis of gastroenteritis, including the ability to simultaneously screen for a wide range of enteric pathogens using multiplex assays. As a result, molecular diagnostics are increasingly being used in the routine laboratory setting for detection, determination and surveillance of a wide range of enteric pathogens. The aim of the Gastroenteritis EQA pilot portfolio is to allow laboratories to assess their ability in the use of molecular diagnostic tests for a range of viral, bacterial and parasitic enteric pathogens. For convenience, the EQA portfolio has been split into viral, bacterial, and parasitic Gastroenteritis panels.

Gastroenteritis Programmes

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical / CulturedMatrix panel format Physiological / synthetic faecal substitutePanel Member Target Range Covering clinical rangePanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Viral GastroenteritisGastroV12 Catalogue Number QAV124152

Viruses are a major cause of gastroenteritis outbreaks. It has been estimated that at least 50% of foodborne gastroenteritis cases are caused by noroviruses. Approximately another 20% of cases, and the majority of severe cases in children, are due to rotavirus. Other clinically significant viral enteropathogens include adenovirus, particularly types 40 and 41, and astroviruses. The aim of the viral Gastroenteritis EQA pilot study is to assess the laboratory’s ability to detect a range of viral pathogens known to cause gastroenteritis using their routine molecular diagnostic platform and procedures. The panel members will resemble clinical samples and will include current clinically relevant norovirus, rotavirus, and adenovirus strains.

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Bacterial GastroenteritisGastroB12 Catalogue Number QAB124153

Different species of pathogenic bacteria are known to cause gastroenteritis. The most common include Salmonella, Shigella, Yersinia, Campylobacter species and various toxicogenic Escherichia Coli species. In severe cases of gastroenteritis for example when hospitalisation is required (often in infants), it is important to distinguish between bacterial and viral enteropathogens. The aim of the bacterial Gastroenteritis EQA pilot study is to assess the laboratory’s ability to detect a range of bacterial pathogens known to cause gastroenteritis using their routine molecular diagnostic platform and procedures. The panel members will resemble clinical samples and will include current clinically relevant strains of Salmonella, Shigella, Yersinia or Campylobacter species.

Parasitic GastroenteritisGastroP12 Catalogue Number QAP124154


Parasites are another frequent cause of Gastroenteritis, and also are a growing risk in this age of global travel. Diagnosis is increasingly important within the routine clinical setting and in the management of potential outbreaks, The aim of the Parasitic Gastroenteritis EQA pilot study is to assess the laboratory’s ability to detect a range of parasitic pathogens known to cause gastroenteritis using their routine molecular diagnostic platform and procedures. The panel members this pilot programme will resemble clinical samples and will include current clinically relevant strains of Giardia, Cryptosporidium, and Entamoeba.

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Candida albicansC.ALBDNA12 Catalogue Number QAF124151

Candida albicans (C. albicans) is a fungus that grows both as yeast and in filamentous form. The fungus is a human commensal organism found in the mouth, gastrointestinal tract, and is an integral part of the normal gut flora. Overgrowth of the fungus results in candidiasis (candidosis) and a common form is thrush, which is usually easily treated in people who are not immunocompromised. However, C. albicans has emerged as an important cause of opportunistic infection in immunocompromised patient groups such as those receiving chemotherapy, transplantation, or with conditions such as HIV/AIDS. In addition, C. albicans has been documented to form biofilms on the surface of implantable medical devices and it has become a major nosocomial health concern, reportedly representing 8% of hospital-acquired bloodstream infections. During the process of host tissue infection it is thought that the usual unicellular yeast-like form of C. albicans reacts to environmental signals and switches into an invasive, multicellular filamentous form (dimorphism). Invasive candidiasis (IC) is a serious cause of morbidity and mortality and over 50% of cases are not diagnosed until after death. The gold standard for the diagnosis of IC has generally been blood culture. However, blood culture can take over 48 hours to give a positive result and identification of a particular Candida species can take a lot longer. This can result in delayed administration of antifungal therapy and appropriate patient care. In addition, because of the historical lack of appropriate diagnostics, patients categorized as high risk are often prescribed antifungal treatment without a diagnosis which increases the risk of future ecological and economic issues. Molecular Diagnostics have been developed in order to assist in the rapid diagnosis of infections, the monitoring of infection persistence, and supporting species-oriented therapy. The aim of this EQA pilot study is to evaluate the current range of molecular techniques reported and ability of the laboratory to use these technologies for the detection of C. albicans. The programme will investigate the diagnostic accuracy of laboratory methods on clinical relevant sample types and the relative reported sensitivity and specificity of the methods used during the EQA pilot.

Feature SpecificationsNumber of Panel Members 8 to 10Sample NA Target Source Cultured / Clinical / Purified Nucleic AcidMatrix panel format Blood / culture matrixPanel Member Target Range Covering clinical and analytical rangePanel Analysis type QualitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

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Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical / CulturedMatrix panel format Whole bloodUnits of Measurement IU/ml, Copies/mlPanel Member Target Range Covering clinical rangePanel Member Sample Volume 1.0 mlPanel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordinglyPanel Analysis type Qualitative & QuantitativePanel Testing Evaluated by various molecular methodologiesStorage / Shipment Conditions <-20°C / Dry-ice

Cytomegalovirus Whole BloodCMVWB12 Catalogue Number QAV124150

Cytomegalovirus (CMV) is an important cause of illness in immunocompromised patients, especially after allogeneic organ or stem cell transplantation. As a result, the measurement for CMV viral load is an essential element in patient management and whole blood is often the matrix of choice for some laboratories when monitoring CMV in patients with haematological diseases. In addition, guidelines including the European Conference on Infections in Leukemia (ECIL 2009) recommend that peripheral blood is used for the diagnosis of CMV. The primary aim of this EQA pilot study is to evaluate the ability of the laboratory in the detection of CMV from whole blood samples. The EQA will investigate quantification ranges in relation to those defined within current guidelines and the precision of the molecular assays at clinically relevant viral loads. Comparisons will also be made to other biologically important matrices including plasma.

MALDI-TOF BacterialMALDIBAC12 Catalogue Number QAB124155

Feature SpecificationsNumber of Panel Members 8 to 12Sample NA Target Source Clinical materialMatrix panel format PhysiologicalPanel Member Target Range Clinically relevant range of bacteria for detection & determinationPanel Analysis type QualitativeStorage / Shipment Conditions <-20°C / Dry-ice

Matrix-Assisted Laser Desorption Ionisation – Time of Flight (MALDI-TOF) is becoming an important diagnostic tool in the microbiological laboratory for the routine identification of bacterial species based on protein and in some cases nucleic acid composition. MALDI-TOF and similar technologies have been shown to be fast, reliable and cost-effective. The technology has potential to reduce the risk of misidentifying unusual organisms and is reportedly capable of correctly identifying the most common bacterial isolates at the species level in 84.1 to 93.6% instances. MALDI-TOF therefore has the potential to complement or possibly replace conventional bacterial phenotypic identification methods. MALDI-TOF does still have some current limitations and these include the identification of some microbial species including; Shigella, pneumococci, and streptococci. These current limitations are often due to the lack of suitable reference strains, standards and in some cases clinical isolates. This means that it can be difficult to obtain sufficient quality data with which to define appropriate reference spectra to update the reference databases. The primary goal of this EQA pilot study is to evaluate the ability of laboratories in the detection and determination of different clinically relevant bacterial strains using MALDI-TOF and other similar mass spectrometry based technologies in the routine microbiology laboratory.

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In memory of,

Stephen Wilson QCMD Quality Manager

1958 to 2011

“To live in hearts we leave behind is not to die.”Thomas Campbell, “Hallowed Ground”

www.qcmd.orgVersion number CAT2012/02

quality control for molecular diagnostics 2012 control for molecular diagnostics 2012 eqa programme...

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