Download catalogue

Quality Control for Molecular Diagnostics
2012
EQA PROGRAMME
CATALOGUE
Version number CAT2012/02
V I RA L
BACTERIAL
SPECIALIST
FUNGAL
PARASITIC
www.qcmd.org
Contents
Viral
Varicella-Zoster virus2
Enterovirus2
Parechovirus3
Herpes simplex virus 1 & 2
3
JC virus and BK virus4
HIV-1 (DNA) programme A & B
4
B19 Virus5
Human Herpes Virus 65
Human Cytomegalovirus6
Epstein-Barr virus6
West Nile Virus7
Dengue Virus7
Cytomegalovirus Dried Blood Spots8
Human Papillomavirus8
Adenovirus9
Influenza A & B virus 9
Human Metapneumovirus 10
Respiratory Syncytial Virus10
Parainfluenza virus
11
Coronavirus11
Rhinovirus 12
Norovirus12
EQA Regulatory Range13
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
Bacterial
Chlamydia trachomatis programme A & B
17
Chlamydophila pneumoniae and Mycoplasma pneumoniae
17
Legionella pneumophila18
Methicillin Resistant S. aureus18
Clostridium difficile
19
Neisseria gonorrhoeae19
M. tuberculosis Complex20
Bordetella pertussis20
Borrelia burgdorferi (Lyme’s Disease)21
Specialist
HCV Genotyping22
HBV Genotyping22
Methicillin Resistant S. aureus Typing
23
HIV-1 Drug Resistance23
HIV-1 Drug Resistance (Integrase)24
Influenza Haemagglutinin Typing
24
Fungal
Aspergillus25
Pneumocystis jirovecii pneumonia (PCP)
25
Parasitic
Toxoplasma gondii26
New EQA
pilot studies
for 2012
Hepatitis A virus27
Hepatitis E virus28
Gastroenteritis programmes29
Viral Gastroenteritis29
Bacterial Gastroenteritis30
Parasitic Gastroenteritis30
Candida albicans31
Cytomegalovirus Whole Blood32
MALDI-TOF Bacterial
32
Version number CAT2012/02
www.qcmd.org
Viral EQA
Varicella-Zoster virus DNA
VZVDNA12
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 immunocompromised hosts such as transplant recipients and AIDS patients.
Feature
Specifications
Number 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
Enterovirus RNA
EVRNA12
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.
Feature
Specifications
Number 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
Version number CAT2012/02
2
www.qcmd.org
Viral EQA
Parechovirus RNA
PeVRNA12
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.
Feature
Specifications
Number 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
Herpes simplex virus 1 & 2 DNA
HSVDNA12
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 (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.
Feature
Specifications
Number of Panel Members
10 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
Version number CAT2012/02
3
www.qcmd.org
Viral EQA
JC virus and BK virus
JCBKDNA12
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
Specifications
Number of Panel Members
10 to 12
Sample NA Target Source
Clinical or Cultured virus
Matrix panel format
Lyophilised Virus Transport Medium (VTM) or plasma
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
HIV-1 DNA
HIVDNA12A & HIVDNA12B
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 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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured proviral cells
Matrix panel format
Frozen PBMC in buffer
Units of Measurement
DNA Copies/Sample
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
0.1 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
4
www.qcmd.org
Viral EQA
B19 virus
B19DNA12
Catalogue Number QAV034116
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical virus
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Human Herpes Virus 6 DNA
HHV6DNA12
Catalogue Number QAV084119
Human 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 HHV6 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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Genotypic Variant
Subtypes A and B
Matrix panel format
Lyophilised Plasma or 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
Version number CAT2012/02
5
www.qcmd.org
Viral EQA
Human Cytomegalovirus DNA
CMVDNA12
Catalogue Number QAV014120
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Lyophilised Plasma, 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
Epstein-Barr virus DNA
EBVDNA12
Catalogue Number QAV024121
Epstein-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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Lyophilised Plasma, 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
Version number CAT2012/02
6
www.qcmd.org
Viral EQA
West Nile Virus RNA
Catalogue Number QAV104141
WNVRNA12
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
Specifications
Number 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
1.0ml
Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Dengue virus RNA
DENVRNA12
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 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.
Feature
Specifications
Number 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
1.0ml
Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
7
www.qcmd.org
Viral EQA
Cytomegalovirus Dried Blood Spots
CMVDBS12
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus and clinical material
Matrix panel format
Whole blood on DBS collection card
Units of Measurement
Copies/ml
Panel Member Target Range
Covering clinical range
Panel Sample Pre-treatment Requirement DNA extraction from dried blood spot
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
Ambient
Human Papillomavirus DNA
HPVDNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Clinically relevant or transport medium
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
8
www.qcmd.org
Viral EQA
Adenovirus DNA
ADVDNA12
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen 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 Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Influenza A & B virus RNA
INFRNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Medium (VTM)
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
9
www.qcmd.org
Viral EQA
Human Metapneumovirus
MPV12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Medium (VTM)
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Respiratory Syncytial virus
RSV12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Medium (VTM)
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
10
www.qcmd.org
Viral EQA
Parainfluenza virus RNA
PINFRNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Medium (VTM)
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Coronavirus RNA
CVRNA12
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 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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Medium (VTM)
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
11
www.qcmd.org
Viral EQA
Rhinovirus RNA
RVRNA12
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Medium (VTM)
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Norovirus RNA
NVRNA12
Catalogue Number QAV084139
Norovirus (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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured whole virus or RNA Transcripts
Matrix panel format
Frozen Virus Transport Medium (VTM) or 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
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
12
www.qcmd.org
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. 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
Version number CAT2012/02
13
www.qcmd.org
Viral EQA
HIV-1 RNA regulatory programme
HIVRNAReg12
Catalogue Number QAS124158
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.
Feature
Specifications
Number 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 material
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml, Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Hepatitis B virus regulatory programme
HBVDNAReg12
Catalogue Number QAS124159
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.
Feature
Specifications
Number of Panel Members
2 full EQA (8 to 10 panel members), 2 core EQA (4 panel members)
Sample NA Target Source
Clinical material
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml, Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
14
www.qcmd.org
Viral EQA
Hepatitis C virus regulatory programme
HCVRNAReg12
Catalogue Number QAS124149
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 underquantitation. 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.
Feature
Specifications
Number of Panel Members
2 full EQA (8 to 10 panel members), 2 core EQA (4 panel members)
Sample NA Target Source
Clinical material
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
HIV-1 RNA
HIVRNA12A & HIVRNA12B
Catalogue Number QAV994108
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
Specifications
Number of Panel Members
8 to 10
Sample NA Target Source
Cultured virus or Clinical material
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml, Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
15
www.qcmd.org
Viral EQA
Hepatitis B virus DNA
HBVDNA12A & 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.
Feature
Specifications
Number of Panel Members
8 to 10
Sample NA Target Source
Clinical material
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml, Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Hepatitis C virus RNA
HCVRNA12A & HCVRNA12B
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 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
Specifications
Number of Panel Members
8 to 10
Sample NA Target Source
Clinical material
Matrix panel format
Frozen Plasma
Units of Measurement
IU/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
16
www.qcmd.org
Bacterial EQA
Chlamydia trachomatis
CTDNA12A & CTDNA12B
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 (NATs) has increased utility for the diagnosis of infection; as well as providing a
rapid and more sensitive alternative to the conventional methods.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured bacteria
Matrix panel format
Lyophilised Urine or Physiological Buffer
Units of Measurement
Copies/vial
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
Dependent on platform
Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Chlamydophila pneumoniae
& Mycoplasma pneumoniae
CP.MP12
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.
Feature
Specifications
Number of Panel Members
10 to 12
Sample NA Target Source
Cultured bacteria
Matrix panel format
Lyophilised bronchoalveolar lavage (BAL) or sample transport medium (STM)
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
0.5 ml
Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
17
www.qcmd.org
Bacterial EQA
Legionella pneumophila
LPDNA12
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 (NATs) are attractive tools for detection of Legionella species in clinical as well as environmental samples.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured bacteria
Matrix panel format
Bronchoalveolar lavage (BAL) or physiological solution
Units of Measurement
GEq/ml, CFU/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
0.5 ml
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Methicillin Resistant S. aureus DNA
MRSADNA12
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 (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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Inactivated cultured MRSA
Matrix panel format
Culture Medium
Units of Measurement
CFU/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
18
www.qcmd.org
Bacterial EQA
Clostridium difficile DNA
CDDNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured bacteria
Matrix panel format
Lyophilised culture medium
Units of Measurement
CFU/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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Neisseria gonorrhoeae DNA
NgDNA12
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 (NATs) has increased utility for the diagnosis of infection; as well as providing a
rapid and more sensitive alternative to conventional methods.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured bacteria
Matrix panel format
Lyophilised Urine
Units of Measurement
Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
Dependent on platform
Panel Sample Pre-treatment Requirement
Reconstitution of lyophilised material
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
19
www.qcmd.org
Bacterial EQA
M. tuberculosis Complex
MTBDNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured Mycobacteria tuberculosis Complex (BCG)
Matrix panel format
Sputum or protein rich buffer
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
0.25 ml
Panel Sample Pre-treatment Requirement
Routine respiratory sample treatment
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Bordetella pertussis
Catalogue Number QAB094132
BPDNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured bacteria
Matrix panel format
Physiological solution
Units of Measurement
CFU/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.0ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
20
www.qcmd.org
Bacterial EQA
Borrelia burgdorferi
BbDNA12
Catalogue Number QAB114147
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured / Clinical material
Matrix panel format
Culture Medium
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
21
www.qcmd.org
Specialist EQA
HCV Genotyping
HCVGT12
Catalogue Number QAS034117
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical material
Genotypic Variant
Various HCV subtypes
Matrix panel format
Frozen Plasma
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Molecular typing
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
HBV Genotyping
HBVGT12
Catalogue Number QAS064118
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical material
Genotypic Variant
Various HBV subtypes
Matrix panel format
Frozen Plasma
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Molecular typing
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
22
www.qcmd.org
Specialist EQA
Methicillin Resistant S. aureus Typing
MRSATP12
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured MRSA strains
Matrix panel format
Culture Medium
Panel Member Target Range
Genetic variants of S. aureus
Panel Member Sample Volume
0.2 ml
Panel Sample Pre-treatment Requirement
Culture followed by standard NA extraction
Panel Analysis type
Molecular typing
Panel Testing
Evaluated by various methodologies
Storage / Shipment Conditions
2-8°C / Ambient
HIV-1 Drug Resistance
ENVA12
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 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.
Feature
Specifications
Number of Panel Members
4 to 7
Sample NA Target Source
Cultured virus or Clinical material
Matrix panel format
Lyophilised Plasma
Panel Member Target Range
Various mutations - Reverse Transcriptase (RT) and Protease (PR) genes
Panel Member Sample Volume
1.0 ml
Panel Sample Pre-treatment Requirement
Reconstitution of lyophilised material
Panel Analysis type
Sequencing
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
23
www.qcmd.org
Specialist EQA
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
Specifications
Number of Panel Members
4 to 7
Sample NA Target Source
Cultured virus or Clinical material
Matrix panel format
Lyophilised Plasma
Panel Member Target Range
Various mutations - Integrase (INT) gene
Panel Member Sample Volume
1.0 ml
Panel Sample Pre-treatment Requirement
Reconstitution of lyophilised material
Panel Analysis type
Sequencing
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Influenza Haemagglutinin Typing
INFHT12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured virus
Matrix panel format
Frozen Virus Transport Meduim (VTM)
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.0ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Molecular typing
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
24
www.qcmd.org
Fungal EQA
Aspergillus DNA
ASPDNA12
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured / Clinical / Purified Nucleic Acid
Matrix panel format
Saline solution
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / 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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured / Clinical material
Matrix panel format
Physiological solution
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
25
www.qcmd.org
Parasitic EQA
Toxoplasma gondii DNA
TGDNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Cultured T. gondii
Matrix panel format
Lyophilised amniotic fluid or plasma
Units of Measurement
Tg /ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
2.0 ml
Panel Sample Pre-treatment Requirement
Reconstitution of lyophilised material
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
2-8°C / Ambient
Version number CAT2012/02
26
www.qcmd.org
New EQA pilot Studies for 2012
Hepatitis A virus
HAVRNA12
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
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical / Cultured
Matrix panel format
Plasma / clinically relevant matrices
Units of Measurement
IU/ml, Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
27
www.qcmd.org
New EQA pilot Studies for 2012
Hepatitis E virus
HEVRNA12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical / Cultured
Matrix panel format
Plasma
Units of Measurement
Copies/ml
Panel Member Target Range
Covering clinical range
Panel Member Sample Volume
1.2 ml
Panel Sample Pre-treatment Requirement
Ready for analysis. Treat as clinical samples and analyse accordingly
Panel Analysis type
Qualitative & Quantitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
28
www.qcmd.org
New EQA pilot Studies for 2012
Gastroenteritis Programmes
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.
Viral Gastroenteritis
GastroV12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical / Cultured
Matrix panel format
Physiological / synthetic faecal substitute
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
29
www.qcmd.org
New EQA pilot Studies for 2012
Bacterial Gastroenteritis
GastroB12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical / Cultured
Matrix panel format
Physiological / synthetic faecal substitute
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Parasitic Gastroenteritis
GastroP12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical / Cultured
Matrix panel format
Physiological / synthetic faecal substitute
Panel Member Target Range
Covering clinical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
30
www.qcmd.org
New EQA pilot Studies for 2012
Candida albicans
C.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
Specifications
Number of Panel Members
8 to 10
Sample NA Target Source
Cultured / Clinical / Purified Nucleic Acid
Matrix panel format
Blood / culture matrix
Panel Member Target Range
Covering clinical and analytical range
Panel Analysis type
Qualitative
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
31
www.qcmd.org
New EQA pilot Studies for 2012
Cytomegalovirus Whole Blood
CMVWB12
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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical / Cultured
Matrix panel format
Whole blood
Units of Measurement
IU/ml, Copies/ml
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
Panel Testing
Evaluated by various molecular methodologies
Storage / Shipment Conditions
<-20°C / Dry-ice
MALDI-TOF Bacterial
MALDIBAC12
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 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.
Feature
Specifications
Number of Panel Members
8 to 12
Sample NA Target Source
Clinical material
Matrix panel format
Physiological
Panel Member Target Range
Clinically relevant range of bacteria for detection & determination
Panel Analysis type
Qualitative
Storage / Shipment Conditions
<-20°C / Dry-ice
Version number CAT2012/02
32
www.qcmd.org
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”
Version number CAT2012/02
www.qcmd.org