eqa programme catalogue - qcmd · quality control for molecular diagnostics 2014 eqa programme...

Qual i ty Control for Molecular Diagnost ics

2014EQA PROGRAMMECATALOGUE

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www.qcmd.orgVersion number CAT2014/01

Contents

Version number CAT2014/01 1 www.qcmd.org

Disease Groups Blood Borne Virus

3 Central Nervous System 3 Congenital Infections 4 Drug Resistance 4 Exotic/Emerging Diseases 5 Gastrointestinal Diseases 5 Immunocompromised Associated Diseases 6 Respiratory Diseases 6 Sexually Transmitted Infections 7 Transplant Associated Diseases 7

Typing 8

Viral

Varicella-Zoster virus 9 Enterovirus 9 Parechovirus 10 Herpes simplex virus 1& 2 10 HIV-1 RNA A & B 11 Hepatitis B virus A & B 11 Hepatitis C virus A & B 12 HIV-1 DNA A & B 12 B19 virus 13 HCV Genotyping 14 HBV Genotyping 14 West Nile virus 15 Dengue virus 15 JC virus 16 BK virus 16 Human Herpes virus 6 17 Epstein-Barr virus 17 Human Cytomegalovirus 18 Human Cytomegalovirus Whole Blood 18 Cytomegalovirus Dried Blood Spots 19 HIV-1 Drug Resistance 20 HIV-1 Drug Resistance (Integrase) 20 Human Papillomavirus 21 Hepatitis A virus 22 Hepatitis E virus 23 HBV Drug Resistance 24 Adenovirus 24 Influenza A & B virus 25 Human Metapneumovirus 25 Respiratory Syncytial virus 26 Parainfluenza virus 26 Coronavirus 27 Rhinovirus 27 Influenza Haemagglutinin Typing 28 Norovirus 28

EQA Regulatory Range 29 HIV-1 RNA regulatory programme 30 Hepatitis B virus regulatory programme 30 Hepatitis C virus regulatory programme 31

http://www.qcmd.org/

Contents


Bacterial Chlamydia trachomatis A & B

32 Neisseria gonorrhoeae A & B 32 Chlamydophila pneumoniae and Mycoplasma pneumoniae 33 Legionella pneumophila 33 Methicillin Resistant S. aureus 34 Clostridium difficile 34 Methicillin Resistant S. aureus Typing 35 M. tuberculosis Complex 35 Borrelia burgdorferi spp. (Lyme Disease) 36 Bordetella pertussis 36

Fungal

Aspergillus 37 Candida spp. 37

Pneumocystis jirovecii pneumonia (PCP) 38

Parasitic

Toxoplasma gondii 39

EQA Pilot Studies

Epstein-Barr virus Whole Blood 40 Extended Spectrum β-lactamase and Carbapenemase 40

Vancomycin Resistant Enterococci 41

Methicillin Resistant S. aureus SPA 41

HCV Drug Resistance 42

Chlamydia psittaci 42

Viral Gastroenteritis 43

Bacterial Gastroenteritis 43 Parasitic Gastroenteritis 44

MALDI-TOF Bacterial 44

New Molecular EQA Pilot Studies for 2014

CMV Drug Resistance 45 Hepatitis D virus 45 Mycoplasma spp. (cell contamination) 46 Measles / Mumps 47

New Serology EQA Pilot Studies for 2014

Blood borne virus serology 48 Viral hepatitis serology 49 Immune status serology 50

Appendix

Programmes in order of distribution 51



Disease Groups

Blood Borne Virus

The Blood-Borne Virus (BBV) group of QCMD External Quality Assessment (EQA)

programmes consists of pathogens that are classically detected directly from

the blood. This includes human immunodeficiency virus (HIV), hepatitis B virus

(HBV), hepatitis C virus (HCV) B19 virus (B19V) and more recently Hepatitis A

virus (HAV), Hepatitis E virus (HEV) and Hepatitis D virus (HDV).

The BBV EQA programmes focus on pathogen load, genotyping and drug

resistance challenges. The EQA panels typically consist of between 5-10 coded

samples, with different viral loads and genotypes, depending on the annual

objectives of the individual BBV EQA programme. For the drug resistance BBV

EQA programmes different current resistance markers are included and emphasis

is placed on the determination and interpretation of these resistance markers.

In addition to the standard viral load and genotyping programmes, QCMD

also offers a regulatory range of EQA programmes for HIV, HCV, and HBV.

The regulatory BBV range of EQA programmes aims to meet the regulatory

requirements of the laboratories under ISO15189 or equivalent.

HIV-1 (RNA)

Hepatitis B virus

Hepatitis C virus

HIV-1 (DNA)

HIV-1 RNA regulatory programme

HBV regulatory programme

HCV regulatory programme

B19 virus

HCV Genotyping

HBV Genotyping

HIV-1 Drug Resistance

HIV-1 Drug Resistance (Integrase)

Hepatitis A virus

Hepatitis E virus

HBV Drug Resistance

HCV Drug Resistance

Hepatitis D virus

Central Nervous System

Infections of the Central Nervous System (CNS) can occur indirectly via

the blood following damage to the blood brain barrier or directly through

intraneuronal routes. Encephalitis and meningitis are important CNS infections

which can have viral, bacterial or parasitic origins.

Viral encephalitis can occur as a result of acute infection or as the consequence

of latent infection. Common viral causes include Herpes Simplex Virus (HSV),

specific Enteroviruses (EV), JC and BK virus, as well as Varicella-Zoster Virus

(VZV). Bacterial infections within the CNS such as meningitis can be a result of

direct infection of the brain or may be due to underlying diseases which can

lead to secondary CNS infection. Parasites such as Toxoplasma gondii can

also cause CNS infections particularly in immunecompromised individuals.

In recent years significant advances have been made in understanding

CNS pathogenesis with the development of molecular technologies for the

diagnosis and monitoring of disease, the introduction of effective treatment

therapies, and, in some cases, the development of vaccines (e.g. Japanese

encephalitis & rabies). The range of QCMD EQA programmes within this area

focus on pathogens known to play a significant clinical role in CNS infection.

The general aim of this group of EQA programmes is to assess the laboratories’

ability in the detection and determination of the selected pathogen. Where

appropriate pathogen load estimation is also evaluated.

Varicella-Zoster virus

Enterovirus

Parechovirus

Herpes simplex virus 1& 2

JC virus

BK virus

West Nile virus

Dengue virus

Toxoplasma gondii

Borrelia burgdorferi spp. (Lyme Disease)

Measles / Mumps



Disease Groups

Congenital Infections

The term congenital infection is used to describe those infections transmitted

from mother to child either during pregnancy (Transplacental infection) or

immediately after childbirth. They can be caused by viruses, bacteria and on

occasion parasites. The ability of a particular pathogen to cross the placenta

and infect the foetus /embryo is dependent on many factors including the

mother’s immune status. Primary infections during pregnancy can result in

spontaneous abortion or major developmental disorders if undetected and

left untreated.

In recent years the diagnosis of congenital infections has been significantly

improved by the ability to obtain clinical samples such as blood through

chorionic villus sampling. In addition the application of molecular technologies

has helped significantly in the diagnosis, monitoring, and treatment rationale.

CMV Dried Blood Spots is one of the EQAs provided in this disease group.

Cytomegalovirus Dried Blood Spots

Toxoplasma gondii

Drug Resistance

The ability of microorganisms to adapt and develop resistance to antimicrobials

is natural and an evolutionary trait they have been employing for thousands

of years. Hence there are many examples of drug resistant strains in viral,

bacterial and parasitic diseases. However it is well recognised that the over

prescription of antimicrobials within clinical practice and their overuse in

domestic products has helped to accelerate drug resistance, and led to the

emergence of multidrug resistance.

QCMD has established a range of Drug Resistance EQA programmes covering

a variety of pathogen types. The primary aims of these programmes are to

assess the laboratory in their ability to detect and determine the presence of

drug resistance at the molecular level. In addition some of the programmes

also cover drug resistance interpretation.

Methicillin Resistant S. aureus

CMV Drug Resistance



Extended Spectrum β-lactamase

and Carbapenemase

Vancomycin Resistant Enterococci

Methicillin Resistant S. aureus SPA

HBV Drug Resistance

HCV Drug Resistance



Disease Groups

Exotic/Emerging Diseases

A complex relationship exists between the pathogen genetics, host and the

environment, as a result predicting the future emergence of exotic diseases is

difficult. However, globalisation coupled with the rapid increases in human

populations over the last 50 years play an important role. Local environmental

changes such as deforestation due to urbanisation bring humans into closer

contact with new potential pathogen vectors. These factors disturb the subtle

balance between pathogen, host and the environment and create the

opportunity for the emergence of new disease pathogens or the re- emergence

of existing pathogens. These diseases can be caused by newly identified

pathogens, pathogen strains such as SARS or the mutation of existing strains such

as Influenza virus. In addition, the spread of known pathogens (e.g. West Nile virus

& Dengue virus) into new geographical areas leading to new potential endemics

account for a large number of exotic / emerging diseases. The EQAs within this

group focus on those emerging diseases that are frequently being identified within

progressive geographic regions.

West Nile virus

Dengue virus

Gastrointestinal Diseases

Gastroenteritis can be caused by a wide variety of bacteria, viruses and

parasites. It is often associated with 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 in order to support patient care. 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 diagnostic techniques are increasingly

being used in the routine laboratory setting for detection, determination and

surveillance of a wide range of enteric pathogens.

The general aim of this group of EQA programmes 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.

Clostridium difficile

Adenovirus

Norovirus

Viral Gastroenteritis

Bacterial Gastroenteritis

Parasitic Gastroenteritis



Disease Groups

Immunocompromised Associated Diseases

The treatment and management of patients with compromised immune

systems has seen important developments in recent years with, for example, the

introduction of novel multi-drug treatment regimes. As a result the healthcare

and management of immunocompromised patients has greatly improved.

However, pathogen infection or viral reactivation remain significant contributors

to morbidity and mortality in these patients.

A number of opportunistic parasitic, fungal and viral pathogens are of concern in

the management of immunocompromised patients due to both acute infection

and reactivation of latent virus in the immunocompromised host.

Advances in molecular diagnostics have allowed accurate pathogen

assessment and quantitative monitoring, particularly of viral activity over time,

which allows early and accurate pre-emptive intervention and management of

antiviral drug therapy.

The range of QCMD EQA programmes within this area focus on pathogens known

to play a significant clinical role in the management of immunocompromised

patients. The general aim of this group of EQA programmes is to assess the ability

of laboratories in the detection of the selected pathogen and where appropriate

quantitative estimation is also evaluated.

JC virus

BK virus

Human Herpes virus 6

Human Cytomegalovirus

Human Cytomegalovirus Whole Blood

Epstein-Barr virus

Epstein-Barr virus Whole Blood

Toxoplasma gondii

Aspergillus

Candida spp.

Pneumocystis jirovecii pneumonia (PCP)

Respiratory Diseases

Respiratory tract infections (RTIs) are common conditions, experienced by

most adults and children each year. They can affect both the upper and

lower respiratory tract and range from the common cold to viral and bacterial

pneumonia. For the young, the elderly and the immune compromised, RTIs can

be a significant health threat if not managed effectively.

RTIs can be caused by a large number of bacterial, viral and fungal pathogens

which have nearly indistinguishable physiological symptoms. This can increase

the chances of undiagnosed or misdiagnosed infections leading to patients

either not receiving critical medications, or receiving unnecessary antibiotics.

The advance of molecular diagnostic techniques has improved our ability

to rapidly determine the causative agents of RTIs and has the potential to

improve patient management, control of nosocomial transmission and

promote targeted therapy.

The Respiratory EQA programmes cover 15 of the major viral, bacterial and

fungal causes of RTIs, focusing on the pathogen load and allowing assessment of

the laboratories’ ability to accurately identify the species of interest at clinically

relevant levels.

Chlamydophila pneumoniae and

Mycoplasma pneumoniae

Legionella pneumophila

M. tuberculosis Complex

Bordetella pertussis

Adenovirus

Influenza A & B virus

Human Metapneumovirus

Respiratory Syncytial virus

Parainfluenza virus

Coronavirus

Rhinovirus

Influenza Haemagglutinin Typing

Chlamydophila psittaci

Pneumocystis jirovecii pneumonia (PCP)



Disease Groups

Sexually Transmitted Infections

Sexually transmitted infections (STIs) remain a major public health concern

throughout the world with some infections reaching epidemic proportions in

sexually active groups. As a result, a number of WHO and UN global strategies

have been initiated in an attempt to control the spread of STIs.

STIs are the main preventable cause of infertility, particularly in women.

However some STIs remain asymptomatic before leading to serious reproductive

complications and congenital infections. Therefore appropriate diagnosis and

treatment is essential.

Molecular diagnostic assays allow the accurate assessment of STIs in patients

that present with similar symptoms or asymptomatic persons from at risk groups

allowing early and accurate intervention and treatment.

The range of QCMD EQA programmes within this area focus on pathogens

known to be the most common cause of STIs. The general aim of this group of

EQA programmes is to assess the ability of laboratories in the detection of the

selected pathogen.

Chlamydia trachomatis

Herpes simplex virus 1& 2

Neisseria gonorrhoeae

Human Papillomavirus

Transplant Associated Diseases

Advances in transplant medicine, including the development of

immunosuppressive agents, has greatly improved the prospects of transplant

recipients. However, pathogen infection and in particular viral reactivation

remain significant contributors to transplant patient morbidity and mortality.

A number of viruses are of particular concern, these include: human herpes virus

6 (HHV6), human cytomegalovirus (CMV) and Epstein-Barr virus (EBV) along with

Human adenovirus (ADV) JC virus (JCV) and BK virus (BKV). Other opportunistic

infections such as the parasite Toxoplasma gondii are also relevant.

Advances in molecular diagnostics have allowed accurate pathogen

assessment prior to transplant and accurate quantitative monitoring, particularly

of viral activity over time, after the transplant has been performed. This in turn

allows early and accurate pre-emptive intervention and antiviral drug therapy.

The range of QCMD EQA programmes within this area focus on those pathogens

known to play a significant clinical role in transplant medicine. The general

aim of this group of EQA programmes is to assess the ability of laboratories in

the detection of the selected pathogen and where appropriate quantitative

estimation is also evaluated.

JC virus

BK virus

Human Herpes virus 6

Human Cytomegalovirus

Human Cytomegalovirus Whole Blood

CMV Drug Resistance

Epstein-Barr virus

Epstein-Barr virus Whole Blood

Toxoplasma gondii

Adenovirus



Disease Groups

Typing

Advances in the treatment and management of patient infection have seen

important developments in recent years. In particular the introduction of novel

antiviral drug therapies has improved the medium and long term prospects of

infected patients. However, the development of drug resistance pathogens is

an increasing complication and remains a significant factor in the treatment of

these patient groups.

The use of genotyping and sequencing technologies has allowed accurate

pathogen assessment and monitoring of patient samples over time. This allows

early and accurate determination of pathogen status. Which in turn allows pre-

emptive intervention and management of antiviral drug therapy.

The range of QCMD EQA programmes within this area focus on pathogens known

to play a significant clinical role in the management of infection. The general

aim of this group of EQA programmes is to assess the ability of laboratories in the

genetic determination of the selected pathogen and where appropriate the

specific mutation points within the target gene.

HCV Genotyping

HBV Genotyping

CMV Drug Resistance

Methicillin Resistant S. aureus Typing



Methicillin Resistant S. aureus SPA

HBV Drug Resistance

HCV Drug Resistance

Influenza Haemagglutinin Typing

MALDI-TOF Bacterial



Viral EQA

Varicella-Zoster virus VZVDNA14 Catalogue Number QAV034103

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.

Feature Specifications

Number of Panel Members 8 to 12

Sample NA Target Source Cultured virus and/or Clinical material

Matrix panel format Transport Medium

Panel Member Target Range Covering clinical range

Panel Member Sample Volume 1.0 ml

Panel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordingly

Panel Analysis type Qualitative. Quantitative for information purposes only

Panel Testing Evaluated by various molecular methodologies

Storage / Shipment Conditions <-20°C / Frozen on Dry-ice

Enterovirus EVRNA14 Catalogue Number QAV984104

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.













Viral EQA

Parechovirus PeVRNA14 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.








Panel Analysis type Qualitative



Herpes simplex virus 1 & 2 HSVDNA14 Catalogue Number QAV994105

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 (NAT) for the detection of HSV DNA has

increased utility for the diagnosis of HSV infection, as well as provided a rapid and more sensitive alternative to other methods.













Viral EQA

HIV-1RNA HIVRNA14A & HIVRNA14B Catalogue Number QAV994108

Recent breakthroughs have significantly contributed to the care and therapy of an estimated 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.




Matrix panel format Plasma

Units of Measurement The primary unit is IU/ml however other units will be accepted




Panel Analysis type Qualitative & Quantitative



Hepatitis B virus HBVDNA14A & HBVDNA14B 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 viraemia in

infected persons, to identify infectious chronic carriers, and to predict and monitor the efficacy of antiviral therapy.














Viral EQA

Hepatitis C virus HCVRNA14A & HCVRNA14B Catalogue Number QAV994112

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 the detection of viraemia, the identification of infectious

chronic carriers and for predicting and monitoring 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 the spread of the disease.



Sample NA Target Source Clinical material









HIV-1 DNA HIVDNA14A & HIVDNA14B Catalogue Number QAV034114

Human 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. This allows the investigation of vertical

transmission of HIV-1 and the assessment of therapeutic interventions aimed at reducing transmission.

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.



Sample NA Target Source Cultured proviral cells

Matrix panel format Physiological Buffer









Viral EQA

B19 virus B19DNA14 Catalogue Number QAV034116

B19 virus is a widespread virus causing a variety of diseases in humans. 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. Therefore, it is 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 thus 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.














Viral EQA

HCV Genotyping HCVGT14 Catalogue Number QAV034117

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.




Genotypic Variant Various HCV subtypes





Panel Analysis type Molecular typing



HBV Genotyping HBVGT14 Catalogue Number QAV064118

It is estimated that 350 million people are infected with Hepatitis B (HBV) 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.




Genotypic Variant Various HBV subtypes










Viral EQA

West Nile virus WNVRNA14 Catalogue Number QAV104141

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.



Sample NA Target Source Cultured Virus



Panel Member Sample Volume Lyophilised

Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material



Storage / Shipment Conditions 2-8°C / Lyophilised Ambient

Dengue virus DENVRNA14 Catalogue Number QAV114148

Dengue virus (DENV) belongs to the flavivirus group of viruses and is an important arthropod borne virus infecting humans.

DENV infection can range from asymptomatic to the severe Dengue haemorrhagic 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.



Sample NA Target Source Cultured Virus










Viral EQA

JC virus JCDNA14 Catalogue Number QAV074106

John Cunningham virus (JCV) is a human polyomavirus with a high prevalence in the global population. Infections are usually

completely asymptomatic and can result in a lifelong latent infection within gastrointestinal and renal cells. The situation is

much more serious in immunocompromised individuals where JCV is capable of reactivating and replicating in the

oligodendrocyte glial cells of the central nervous system. This reactivation may result in the individual developing an often fatal

condition known as progressive multifocal leukoencephalopathy. Therefore, it is essential that early, sensitive and accurate

diagnosis of active JCV infection is performed which will not only allow pre-emptive treatment of infection but can increase

the selectivity of antiviral therapy thus reducing drug side-effects. This EQA programme will focus on the detection and

quantitation of the JCV within the routine clinical laboratory setting.




Matrix panel format Transport Medium and/or Plasma

Units of Measurement The primary unit is Copies/ml however other units will be accepted







BK virus BKDNA14 Catalogue Number QAV144166

Polyoma BK virus (BKV) is a human virus with a high prevalence in the global population with up to 90% of the adult population

BKV seropositive. In immunocompetent individuals primary infection with BKV is most often asymptomatic and forms a latent

infection of the genitourinary tract. In immunosuppressed renal transplant patients BKV reactivation is common (10-68%) and

can lead to polyoma BKV Nephropathy (EBVN). Treatment of BKV infection relies on the modulation of immunosuppressive

therapy until the viral load has been sufficiently diminished or cleared. Early intervention and monitoring of viral load are critical

factors in managing patients therefore a diagnostic method must provide both early detection and be able to monitor EBV

replication in response to the treatment regime. This EQA programme will focus on the detection and quantitation of the BKV

within the routine clinical laboratory setting.














Viral EQA

Human Herpes virus 6 HHV6DNA14 Catalogue Number QAV084119

Human Herpes virus 6 (HHV-6) is one of the most widespread human betaherpes 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.

Immunosuppression in an individual can lead to reactivation of the virus and associated sequelae. Early detection of

HHV-6 is crucial for effective management 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.




Genotypic Variant Subtypes A and B









Epstein-Barr virus EBVDNA14 Catalogue Number QAV024121

Epstein-Barr virus is a widespread human gamma-herpes virus associated with a broad spectrum of epithelial and

lymphoproliferative 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.














Viral EQA

Human Cytomegalovirus CMVDNA14 Catalogue Number QAV014120

Cytomegalovirus (CMV) is a betaherpes 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. Therefore, it is essential that early accurate diagnosis is performed which will allow pre-emptive

treatment of infection but also increase the selectivity of antiviral therapy thus 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.












Cytomegalovirus Whole Blood CMVWB14 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 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.




Matrix panel format Whole Blood










Viral EQA

Cytomegalovirus Dried Blood Spots CMVDBS14 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, to allow clinical treatment of infection and 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.




Matrix panel format Dried Blood Spots




Panel Sample Pre-treatment Requirement DNA extraction from dried blood spot



Storage / Shipment Conditions Ambient



Viral EQA

HIV-1 Drug Resistance ENVA14 Catalogue Number QAV024131

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 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 the HIV-1 RT and

Pro genes in plasma has become an integral part of HIV-1 antiviral drug therapy management for infected individuals.

Genotyping the 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.





Panel Member Target Range Various mutations - Reverse Transcriptase (RT) and Protease (PR) genes



Panel Analysis type Sequence Analysis



HIV-1 Drug Resistance (Integrase) ENVAINT14 Catalogue Number QAV114146

Integrase inhibitors that target the integrase (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 the HIV-1 integrase gene in plasma has become

part of HIV-1 antiviral drug therapy management 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.





Panel Member Target Range Various mutations - Integrase (INT) gene








Viral EQA

Human Papillomavirus HPVDNA14 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 effective triage, quantitative detection and accurate

HPV-typing at clinically relevant levels is 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.



Sample NA Target Source Clinical material and/or Cell lines containing HPV

Matrix panel format Transport Medium (PreservCyt)




Storage / Shipment Conditions 15-30°C / Liquid Ambient



Viral EQA

Hepatitis A virus HAVRNA14 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. An 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 is to evaluate the ability of laboratories in the detection of HAV and investigate comparative

molecular quantification in terms of sensitivity and specificity within the clinical context.













Viral EQA

Hepatitis E virus HEVRNA14 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 known genotypes of HEV

(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.

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 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.













Viral EQA

HBV Drug Resistance HBVDR14 Catalogue Number QAV124160

Antiviral therapy that specifically targets the Reverse Transcriptase (RT) gene of the Hepatitis B Virus is a routine part of patient

management within chronic HBV infected individuals. However, the effectiveness of HBV antiviral therapy is constantly

challenged by the rise in drug HBV resistance strains. As a result, the rapid genotyping of the HBV RT gene is becoming

increasingly important in the management of HBV antiviral drug therapy. Genotyping the HBV RT gene allows the

determination of base-line HBV RT genotype before, during, and after drug therapy. This allows the identification of potential

drug resistance strains and the ability to differentiate between resistance caused by viral mutation and other potential sources

of increased HBV viral load. This will in turn provide valuable information which the clinician can use in order to rationalise HBV

drug antiviral therapy and promote better patient management.

The aim of the HBV Drug Resistance Typing EQA is to assess the laboratory’s ability to detect a range of known HBV drug

resistance mutations using their routine molecular diagnostic platform and procedures.



Sample NA Target Source Cultured material and/or Clinical material


Panel Member Target Range Various mutations - Reverse Transcriptase (RT)

Panel Sample Pre-treatment Requirement Ready for analysis




Adenovirus ADVDNA14 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.













Viral EQA

Influenza A & B virus INFRNA14 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.











Human Metapneumovirus MPV14 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


hMPV infection. As a result, these tests have become of great practical and clinical relevance.













Viral EQA

Respiratory Syncytial virus RSV14 Catalogue Number QAV054142

Human respiratory syncytial virus (RSV) is an important cause of mortality and morbidity in young children, the elderly and

immunocompromised 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


RSV infection. As a result, these tests have become of great practical and clinical relevance.











Parainfluenza virus PINFRNA14 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.













Viral EQA

Coronavirus CVRNA14 Catalogue Number QAV064137

Human 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 immunocompromised 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.











Rhinovirus RVRNA14 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.













Viral EQA

Influenza Haemagglutinin Typing INFHT14 Catalogue Number QAV064138

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.






Panel Member Sample Volume 1.0ml





Norovirus NVRNA14 Catalogue Number QAV084139

Norovirus (NV) is a single stranded RNA virus of the Caliciviridae family. 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.



Sample NA Target Source Cultured material and/or Clinical material and/or Purified nucleic acid

Matrix panel format Transport Medium and/or Physiological Buffer

Panel Member Sample Volume 1.0ml VTM, 0.1ml Buffer

Panel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical or semi-processed samples






Viral EQA

EQA Regulatory Range

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, 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.

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



Viral EQA

HIV-1 RNA regulatory programme HIVRNAReg14 Catalogue Number QAV124158

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.


Number of Panel Members 4 challenges consisting of 4 panel members










Hepatitis B virus regulatory programme HBVDNAReg14 Catalogue Number QAV124159

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 lower and upper limit of detections of the assay

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.














Viral EQA

Hepatitis C virus regulatory programme HCVRNAReg14 Catalogue Number QAV124149

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 base-line 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.














Bacterial EQA

Chlamydia trachomatis CTDNA14A & CTDNA14B Catalogue Number QAB004101

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 (NAT) has increased utility for the diagnosis of infection, as well as providing a rapid

and more sensitive alternative to the conventional methods.



Sample NA Target Source Cultured bacteria and/or Clinical material

Matrix panel format Urine and/or Physiological Buffer







Neisseria gonorrhoeae NgDNA14A & NgDNA14B Catalogue Number QAB034126

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 (NAT) has increased utility for the diagnosis of infection, as well as providing a rapid

and more sensitive alternative to conventional methods.




Matrix panel format Urine and/or Physiological Buffer









Bacterial EQA

Chlamydophila pneumoniae & Mycoplasma pneumoniae

CP.MP14 Catalogue Number QAB084107

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.




Matrix panel format Bronchoalveolar Lavage (BAL) and/or Transport Medium







Legionella pneumophila LPDNA14 Catalogue Number QAB044122

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

(NAT) are attractive tools for detection of Legionella species in clinical as well as environmental samples.




Matrix panel format Bronchoalveolar lavage (BAL) and/or Transport Medium








Bacterial EQA

Methicillin Resistant S. aureus MRSADNA14 Catalogue Number QAB064124

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 (NAT) 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.




Matrix panel format Microbiological Medium and/or Transport Medium







Clostridium difficile CDDNA14 Catalogue Number QAB084125

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.













Bacterial EQA

Methicillin Resistant S. aureus Typing MRSATP14 Catalogue Number QAB074128

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.





Panel Member Target Range Genetic variants of S. aureus


Panel Sample Pre-treatment Requirement Culture followed by standard NA extraction


Panel Testing Evaluated by various methodologies


M. tuberculosis Complex MTBDNA14 Catalogue Number QAB014129

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.



Sample NA Target Source Cultured Mycobacteria tuberculosis Complex (BCG)

Matrix panel format Sputum and/or Synthetic Sputum and/or Synthetic CSF



Panel Sample Pre-treatment Requirement Routine respiratory sample treatment






Bacterial EQA

Borrelia burgdorferi (Lyme Disease)

BbDNA14 Catalogue Number QAB114147

Lyme borreliosis, caused by the spirochete Borrelia burgdorferi (Bb), is one of the fastest spreading diseases particularly in

Europe and the USA. Early diagnosis of Bb 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 Bb at the early stages infection. As a result, these tests have become of great practical and

clinical relevance.









Bordetella pertussis BPDNA14 Catalogue Number QAB094132

Whooping cough is caused by the bacterium Bordetella pertussis (BP). 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.













Fungal EQA

Aspergillus ASPDNA14 Catalogue Number QAF104140

The diagnosis of invasive aspergillosis is challenging as 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 (NAT) are attractive tools for

detection of Aspergillus species in clinical samples. However a lack of standardisation has hindered widespread acceptance.




Matrix panel format Plasma and/or Physiological Buffer and/or Synthetic Sputum





Candida spp. CANDNA14 Catalogue Number QAF124151

The incidence of fungal infections has increased considerably in recent years. Fungi can infect almost any part of the body, or

can be systemic with immunocompromised patients particularly at risk. In these patients, invasive fungal infections are often

severe, progress rapidly and are difficult to diagnose and/or treat.

Candida species are responsible for most fungal infections with Candida albicans the main cause of candidosis. However,

non - Candida albicans species such as Candida tropicalis and Candida parapsilosis are now frequently identified as human

pathogens. Infections caused by Candida glabrata and Candida rugosa have also arisen as they are frequently less

susceptible to the currently used azole antifungals. Furthermore many phenotypic similarities between the different species

caused problems in the identification of isolates and have previously led to misidentification of species. This can result in

delayed administration of antifungal therapy and appropriate patient care.

Molecular Diagnostics have been developed in order to assist in the rapid diagnosis and management of infection.

The aim of this EQA programme is to evaluate the current range of molecular techniques reported and the ability of the

laboratory to use these technologies for the detection of Candida species. 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.




Matrix panel format Plasma and/or Physiological Buffer

Panel Member Target Range Covering clinical and analytical range






Fungal EQA

Pneumocystis jirovecii pneumonia (PCP) PCPDNA14 Catalogue Number QAF114144

Pneumocystis pneumonia (PCP) is a common opportunistic infection associated with mortality and morbidity especially in

immunocompromised 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.











Parasitic EQA

Toxoplasma gondii TGDNA14 Catalogue Number QAP044123

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. In addition 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 (NAT) are attractive tools for detection

of TG in a variety of clinical samples.



Sample NA Target Source Cultured material and/or clinical material

Matrix panel format Amniotic Fluid and/or Plasma









EQA pilot Studies

Epstein-Barr virus Whole Blood EBVWB14 Catalogue Number QAV134161

Epstein-Barr virus (EBV) is associated with a broad spectrum of epithelial and lymphoproliferative disorders which are an

important cause of mortality and morbidity especially in immunocompromised hosts. As a result, the measurement for EBV viral

load is an essential element in patient management and whole blood is often a common matrix when monitoring these

patients. The primary aim of this EQA is to evaluate the ability of the participating laboratory in the detection of EBV from whole

blood samples. The EQA will investigate quantification ranges of the molecular assays at clinically relevant viral loads.




Matrix panel format Whole Blood








Extended Spectrum β-lactamase

and Carbapenemase

ESBL14 Catalogue Number QAB134162

The emergence of antibiotic resistance organisms, in particular multi-drug resistant bacteria, has become a major issue for

nosocomial infection control throughout the world. Extended-spectrum β-lactamase (ESBL) -producing bacteria are a major

contributor to this problem. Carbapenems have been invaluable for the treatment of ESBL-producing bacteria. However,

the increasing use of carbapenems has contributed to the emergence of carbapenem-resistant bacteria. Therefore

detection and surveillance of ESBL and carbapenemase-producing organisms has become extremely important for the

selection of appropriate therapy and the implementation of infection control measures.

Molecular diagnostic technologies can quickly and accurately identify ESBL and carbapenemase-producing bacteria in a

variety of sample types. As a result, molecular diagnostics have become an important tool for the clinical laboratory

detection, determination, and control of infections. This EQA will focus on the laboratories’ ability to detect and determine

different ESBL and carbapenemases in a clinical setting.




Genotypic Variant Various Drug resistance strains






EQA pilot Studies

Vancomycin Resistant Enterococci VRE14 Catalogue Number QAB134163

Enterococci are a prominent cause of nosocomial infections. The emergence of vancomycin-resistant enterococci (VRE) has become a serious issue in hospitals throughout the world. Infection control measures within hospitals have been demonstrated to greatly reduce the spread of VRE infection. However this depends on the rapid identification of VRE. Molecular Diagnostic technologies play an important role in the screening and surveillance of VRE. They are essential tools for the clinical laboratory in the detection and determination of VRE. This EQA will focus on the laboratories’ ability to detect and determine different VRE in clinically relevant sample types using molecular techniques.




Genotypic Variant Various Drug resistance strains




Methicillin Resistant S. aureus SPA MRSASPA14 Catalogue Number QAB134164

Methicillin-Resistant S. aureus (MRSA) surveillance measures are integral to monitoring the spread of antimicrobial resistance

within hospitals and the wider community. These measures depend in part, on the rapid and accurate typing of MRSA.

Molecular-based typing methods that target variation in the polymorphic region X of the S. aureus protein A (spa) gene can

quickly and accurately genotype MRSA in a variety of clinical sample types. Spa typing is becoming established as one of

the leading methods for MRSA surveillance and outbreak analysis which has been aided by the use of widely used data

analysis software packages and easily accessible spa sequence databases. The aim of this EQA is to assess the laboratories’

ability in the use of spa typing as a technique for the identification of MRSA.









EQA pilot Studies

HCV Drug Resistance HCVDR14

Catalogue Number QAV134167

Hepatitis C virus (HCV) infection represents a major public health problem, affecting 170 million people worldwide. It is the

main cause of acute and chronic hepatitis. The majority of infected individuals progress to chronic infection, which leads to

liver cirrhosis, hepatocellular carcinoma, and ultimately the requirement for liver transplantation. At present there are no

effective vaccines available. In addition, standard approaches to HCV treatment (pegylated interferon, PEG IFN) are

limited and often difficult for the patient to tolerate. A number of new therapies are starting to become available. These

include direct-acting antiviral (DAA) drugs such as those targeted against the HCV protease inhibitors. Two DAA drugs that

target the HCV NS3 protease (boceprevir and telaprevir) have been approved for the treatment of HCV infections.

Treatment success rates have been shown to improve dramatically when DAA drugs are administered in combination with

PEG-IFN and ribavirin. However in vitro and in vivo studies have shown that DAA drugs may be susceptible to drug

resistance. Therefore the identification of specific drug resistance mutations within the HCV virus is becoming increasingly

important in the clinical management of HCV infection. The aim of the HCV Drug Resistance Typing EQA is therefore to

assess the laboratories’ ability to detect HCV drug resistance mutations using their routine molecular diagnostic platform

and procedures.





Panel Member Target Range Various mutations - Protease (PR)

Panel Sample Pre-treatment Requirement Ready for analysis




Chlamydophila psittaci CPS14 Catalogue Number QAB134165

Chlamydophila psittaci is a widespread zoonotic bacterial infection that can result in severe pneumonia and other serious

health problems in humans. Direct detection of Chlamydophila psittaci by culture is hazardous and requires specialist

facilities. Alternative sero-diagnostic procedures lack specificity at the Chlamydophila species level. The development of

nucleic acid amplification technology (NAT) diagnostic tests for Chlamydophila psittaci that are sensitive and species

specific has resulted in these tests becoming of increased practical and clinical relevance. The aim of this EQA is to assess

the laboratories' ability in the molecular detection of Chlamydophila psittaci.









EQA pilot Studies

Viral Gastroenteritis GastroV14 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 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 may include current clinically relevant strains of norovirus, rotavirus, and adenovirus.




Matrix panel format Synthetic Faecal Matrix and/or Physiological Buffer





Bacterial Gastroenteritis GastroB14 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 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 may include current clinically relevant strains of Salmonella, Shigella, Yersinia or Campylobacter species.











EQA pilot Studies

Parasitic Gastroenteritis GastroP14 Catalogue Number QAP124154

Parasites are a frequent cause of Gastroenteritis and 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 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 will resemble

clinical samples and may include current clinically relevant strains of Giardia, Cryptosporidium, and Entamoeba.









MALDI-TOF Bacterial MALDIBAC14 Catalogue Number QAB124155

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 the 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 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.





Panel Member Target Range Clinically relevant range of bacteria for detection & determination


Storage / Shipment Conditions Ambient




CMV Drug Resistance CMVDR14 Catalogue Number QAV144169

Cytomegalovirus (CMV) is a betaherpes virus with a high prevalence (40-80%) within the population. The virus is normally

latent and asymptomatic. However within subpopulation groups such as the immunocompromised and / or those on

transplantation treatments CMV infection results in high rates of mortality and morbidity rates.

Antiviral drug such as ganciclovir, (prodrug valganciclovir), foscarnet, and cidofovir have been shown to be effective in the

treatment of early stage active CMV infection. However, drug resistance conferred by mutations within the viral DNA

polymerase (pol) gene are now becoming of major concern.

The aim of the CMV Drug Resistance EQA pilot study is therefore to assess the laboratories’ ability to detect CMV drug

resistance mutations using their routine molecular diagnostic platform and procedures.







Hepatitis D virus HDV14 Catalogue Number QAV144170

Hepatitis D virus (HDV) is a single stranded RNA satellite virus that can be classified into three genotypes designated I, II and III.

Genotype I is considered the most prevalent and is associated with a broad spectrum of disease worldwide. Genotype II is

mainly restricted to parts of Asia and is less severe than genotype I. Genotype II is found in South America and is responsible

for a more severe form of delta hepatitis. As an RNA satellite virus, HDV is closely associated with hepatitis B and it relies on

hepatitis B virus (HBV) for the production of envelope proteins during transmission. Therefore, co-infection with HBV or super-

infection of a host already carrying HBV is required for HDV infection. As a result, HDV distribution closely parallels that of HBV.

Molecular techniques are already an important diagnostic and monitoring tool for HBV and similar techniques are now being

introduced for the fast and accurate diagnosis of HDV.

The primary aim of this EQA pilot study is to evaluate laboratories in the detection of HDV within the routine clinical setting.











Mycoplasma spp. (cell contamination) MYCO14 Catalogue Number QAB144168

Mycoplasma species are a common source of cell culture contamination and recent surveys suggest that over 15% of cell

cultures in U.S. laboratories alone are contaminated with Mycoplasma. The importance of Mycoplasmas in cell culture should

not be underestimated as the presence of Mycoplasma can induce significant changes in the cellular morphology,

metabolism, and cell growth. As a result Mycoplasmas pose potential biosafety concerns to the efficacy and quality of

biopharmaceuticals such as vaccines and other cell based therapeutics. Mycoplasma contamination may also impact

directly on the validity of cell models used for fundamental research. The most common sources of contamination are

inappropriate laboratory practice and the lack of aseptic technique resulting in contaminated laboratory equipment. In

addition, contaminated cell culture reagents and the transfer of contaminated cell culture materials from laboratory to

laboratory also account for a high percentage of the Mycoplasma contamination observed within the laboratory. Therefore

maintaining cell culture integrity through the appropriate control, screening, and testing for Mycoplasma is essential in the

expanding field of cell based research and therapeutics.

Over the years several antibiotic based anti-mycoplasma reagents have been developed, however these approaches

remain ineffective so screening and removing Mycoplasma contaminated material is the preferred option. Techniques such

as conventional microscopy have also been shown to be ineffectual because of the size of the Mycoplasma cells (less than

1 µm). Hence molecular techniques are becoming the method of choice because of the potential advantages they

provide.

Although there are International pharmacopoeias which provide guidance and regulations concerning Mycoplasma testing

of cell line material and cell based biologicals it has been estimated that over 50% of US laboratories do not regularly screen

for mycoplasma. As a result the importance of mycoplasma testing and screening of cell line material is not always fully

considered within the laboratory. The aim of this EQA pilot study is to evaluate current laboratory approaches for the

molecular detection of Mycoplasma species.



Sample NA Target Source Cultured material








Measles / Mumps MM14 Catalogue Number QAV144171

Mumps & Measles are acute viral illnesses caused by RNA viruses of the paramyxovirus family. Globally, Measles remains a

leading cause of morbidity and mortality with an estimated 770,000 deaths annually. In addition complications associated

with Mumps include aseptic meningitis and, although less common, encephalitis which can result in death or permanent

disability.

In recent years, worldwide vaccination programmes have been effective in reducing morbidity and mortality rates. However

inconsistences in vaccination coverage such as the health scare associated with the introduction of the trivalent form of the

vaccine for Measles, Mumps, and Rubella (MMR) can lead to resurgences and outbreaks.

Conventional laboratory diagnostic methods including serology or viral culture often lack sensitivity and can be time

consuming especially in regions where there is a low prevalence of disease due to the high uptake of vaccination. Hence

the use of molecular diagnostics plays an important role in the confirmation of acute infection. In addition, the genotyping of

mumps and measles can provide information regarding the epidemiology of the viruses within an outbreak and also for

differentiating vaccine strain from wild-type. The aim of this EQA pilot study is to evaluate the current use of molecular

technologies for the detection, determination and genotyping of mumps and measles within the routine clinical laboratory

setting.











Serology Introduction The new Serology EQA range for 2014 will complement the current QCMD molecular range. It has been designed to monitor

the performance of laboratories using antibody and antigen tests within the routine clinical diagnostic setting.

The Serology EQA’s will focus on three principal areas:

• Blood Borne Virus

• Viral Hepatitis

• Immune Status

Each serology programme will consist of two distributions per year with six panel members per distribution. The panels within

each of the programmes will consist of patient samples representing a range of serotypes. Panel members may consist of

single antibody / antigen samples and/or multiple antibody / antigen samples. In addition, depending upon the objectives

within each distribution, some panel members will include the use of confirmatory testing.

All materials used within each of the serology programmes have been extensively characterised and each panel is provided

in a ready to use format. As is standard with all QCMD EQA programmes, participants within the serology EQA programmes

will be able to report their results electronically through QCMD’s on-line Information Technology EQA Management System

(ITEMS). In addition to the customary qualitative analysis, the serology programmes will aim to provide post analytical phase

evaluation and feedback on clinical interpretation.

Blood borne virus serology BBVSERO14 Catalogue Number QAS144172

This programme will cover a wide variety of blood borne virus serological markers for HIV, HCV, HBV and HTLV. Within each

distribution there will be different markers presented within the panel. For each panel member, the primary focus will be on

the qualitative detection of the relevant serological marker(s) in each panel member.



Sample material Human plasma

Parameters HIV: antiHIV-1, antiHIV2, HIVAg/Ab (combo test),

confirmatory testing (immunoblot)

HTLV: antiHTLV-1, antiHTLV-2

HCV: antiHCV, HCVAg, confirmatory testing (immunoblot)

HBV: HBsAg, antiHBc

Units of Measurement Various: IU/L, ratio, etc

Panel Member Target Range At clinically relevant levels


Panel Sample Pre-treatment Requirement Ready-to-use (after thawing)


Panel Testing Evaluated by various serological methods





Viral hepatitis serology VHSERO14 Catalogue Number QAS144173

This programme will cover a wide variety of viruses associated with viral hepatitis. The primary focus will be on the qualitative

determination of the relevant serological markers within each panel member and the interpretation of the results performed

by the laboratory. Within each distribution there will be different markers presented within the panel.




Parameters HAV: IgM-antiHAV, antiHAV (total)

HBV: HBsAg, HBeAg, antiHBc (IgM/total), antiHBe, antiHBs

HCV: anti-HCV, HCV-Ag, confirmatory testing (immunoblot)

HEV: IgM-antiHEV, antiHEV (total)











Immune status serology ISSERO14 Catalogue Number QAS144174

This aim of this serological EQA programme is to assess the laboratories ability to determine the immune status of the sample

based on the serological markers present and the clinical information provided. Within each distribution there will be different

serological markers presented within the panel. The pilot EQA will cover a wide variety of serological markers associated with

immune status and the laboratory will be expected to report the presence or absence of each marker within each of the

panel members provided.




Parameters HAV: antiHAV (total)

HBV: antiHBs

MMR: mumps, measles, rubella antibodies

STD : antibodies to HSV-2, Chl. Trachomatis, T. pallidum

Tx : antibodies to CMV, EBV, T. gondii

Pregnancy : B19, CMV, VZV, T. gondii










Appendix

QAB014129 M. tuberculosis Complex

QAV024131 HIV-1 Drug Resistance

QAV114146 HIV-1 Drug Resistance (Integrase)

QAV094130 Human Papillomavirus

QAB134162 Extended Spectrum ß-lactamase and

Carbapenemase

QAB134163 Vancomycin Resistant Enterococci

QAB134164 Methicillin Resistant S. aureus SPA

QAV994108 HIV-1 (RNA) B

QAV994110 Hepatitis B virus B

QAV994112 Hepatitis C virus B

QAV034114 HIV-1 (DNA) B

QAV124156 Hepatitis A virus

QAV124157 Hepatitis E virus

QAV124160 HBV Drug Resistance

QAV134167 HCV Drug Resistance

QAV144170 Hepatitis D virus

QAF104140 Aspergillus

QAF124151 Candida spp.

QAF114144 Pneumocystis jirovecii pneumonia (PCP)

QAB114147 Borrelia burgdorferi spp. (Lyme Disease)

QAV104141 West Nile virus

QAV114148 Dengue virus

QAV074106 JC virus

QAV144166 BK virus

QAV084119 Human Herpes virus 6

QAV014120 Human Cytomegalovirus

QAV124150 Human Cytomegalovirus Whole Blood

QAV024121 Epstein-Barr virus

QAV134161 Epstein-Barr virus Whole Blood

QAV144169 CMV Drug Resistance

QAV064127 Cytomegalovirus Dried Blood Spots

QAB074128 Methicillin Resistant S. aureus Typing

QAB004101 Chlamydia trachomatis B

QAB034126 Neisseria gonorrhoeae B

Programmes in order of distribution

Catalogue

Number Programme Description

Catalogue

Number Programme Description

Quarter 1 Quarter 3

Quarter 2

Quarter 4

QAB004101 Chlamydia trachomatis A

QAB034126 Neisseria gonorrhoeae A

QAV034103 Varicella-Zoster virus

QAV984104 Enterovirus

QAV114145 Parechovirus

QAV994105 Herpes simplex virus 1& 2

QAB084107 Chlamydophila pneumoniae and Mycoplasma pneumoniae

QAB044122 Legionella pneumophila

QAB064124 Methicillin Resistant S. aureus

QAB084125 Clostridium difficile

QAV994108 HIV-1 (RNA) A

QAV994110 Hepatitis B virus A

QAV994112 Hepatitis C virus A

QAV034114 HIV-1 (DNA) A

QAV124158 HIVRNA regulatory programme

QAV124159 HBV regulatory programme

QAV124149 HCV regulatory programme

QAV034116 B19 virus

QAV034117 HCV Genotyping

QAV064118 HBV Genotyping

QAS144172 Blood borne virus serology

QAS144173 Viral hepatitis serology

QAS144174 Immune status serology

QAB094132 Bordetella pertussis

QAV054133 Adenovirus

QAV054134 Influenza A & B virus

QAV054135 Human Metapneumovirus

QAV054142 Respiratory Syncytial virus

QAV064136 Parainfluenza virus

QAV064137 Coronavirus

QAV064143 Rhinovirus

QAV064138 Influenza Haemagglutinin Typing

QAV084139 Norovirus

QAB134165 Chlamydophila psittaci

QAP044123 Toxoplasma gondii

QAV124152 Viral Gastroenteritis

QAB124153 Bacterial Gastroenteritis

QAP124154 Parasitic Gastroenteritis

QAB124155 MALDI-TOF Bacterial

QAB144168 Mycoplasma spp. (cell contamination)

QAV144171 Measles / Mumps


eqa programme catalogue - qcmd · quality control for molecular diagnostics 2014 eqa programme...

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