Version number CAT2018/02€¦ · Viral Gastroenteritis 63 Zika Virus 64 Serology EQA Pilot Studies...

Version number CAT2018/02

www.qcmd.org

Contents

Version number CAT2018/02 2 www.qcmd.org

An Introduction to the QCMD EQA Schemes 5

EQA Groups

Blood Borne Virus 6

Central Nervous System 6 Congenital Infections 7

Drug Resistance 7 Exotic/Emerging Diseases 8 Gastrointestinal Diseases 8 Immunocompromised Associated Diseases 9 Multiple Pathogen/Syndromic

Respiratory Diseases

Serology

9 10 10

Sexually Transmitted Infections 11 Transplant Associated Diseases 11 Typing 12

Viral EQA

Adenovirus 13

B19 virus 13

BK virus 14 Chikungunya virus 14 CMV Drug Resistance 15 Coronavirus 15 Cytomegalovirus Dried Blood Spots 16

Cytomegalovirus Whole Blood 16 Dengue virus 17 Enterovirus 17

Epstein-Barr virus 18

Epstein-Barr virus Whole Blood 18

HBV Drug Resistance 19 HBV Genotyping 19

HCV Drug Resistance 20 HCV Genotyping 20 Hepatitis A virus 21 Hepatitis B virus 21

Hepatitis C virus 22

Hepatitis D virus 22

Hepatitis E virus 23 Herpes simplex virus 1& 2 23 HIV-1 (DNA) 24 HIV-1 (RNA) 24

HIV-1 Drug Resistance 25

HIV-1 Drug Resistance (Integrase) 25 Human Cytomegalovirus 26 Human Herpes virus 6 26

Human Metapneumovirus 27

Human Papillomavirus 27

Contents


Influenza A & B virus 28 Influenza Haemagglutinin Typing 28 JC virus 29

Measles / Mumps 29 MERS Coronavirus 30

Norovirus 30 Parainfluenza virus 31 Parechovirus 31 Respiratory Syncytial virus 32 Rhinovirus 32 Varicella-Zoster virus 33 West Nile virus 33

Bacterial EQA

Bordetella pertussis 34

Borrelia burgdorferi spp. (Lyme Disease) 34 Chlamydia psittaci 35 Chlamydia trachomatis 35 Chlamydia trachomatis and Neisseria gonorrhoeae 36

Chlamydophila pneumoniae 36

Clostridium difficile 37 Legionella pneumophila 37 Methicillin Resistant Staphylococcus aureus 38 Methicillin Resistant Staphylococcus aureus Typing

(epidemiology and outbreak studies) 38

Mycobacterium tuberculosis 39

Mycoplasma pneumoniae 39 Mycoplasma spp. (cell contamination) 40

Neisseria gonorrhoeae 40

Staphylococcus aureus spa 41

Syphilis 41

Fungal EQA

Aspergillus spp. 42

Candida spp. 42

Pneumocystis jirovecii pneumonia (PCP) 43

Parasitic EQA

Toxoplasma gondii 44

Contents


EQA Pilot Studies Bacterial 16S Ribosomal RNA 45 Bacterial Gastroenteritis 46 CNSI (Viral) 47 CNSII (Non-viral) 47 Dermatophytosis 48

Diarrheagenic Escherichia coli 49 Enterovirus Typing 50 Extended Spectrum ß-lactamase and Carbapenemase 51 Group B Streptococcus 52 Helicobacter pylori 53 Herpes simplex virus drug resistance 54 Immunocompromised 55 MALDI-TOF 56 Neonatal / Newborn infections 57

Parasitic Gastroenteritis 58 Respiratory I 58

Respiratory II 59

Respiratory II 59

Sepsis 60

Sexually Transmitted Infections I 61 Sexually Transmitted Infections II 61 Transplantation (Viral) 62 Vancomycin Resistant Enterococci 62

Viral Gastroenteritis 63

Zika Virus 64

Serology EQA Pilot Studies

Serology Introduction 65 Bloodborne virus serology 65

Immune status serology 66 Viral hepatitis serology 67

New Molecular EQA Pilot Studies for 2018

Human Papillomavirus (SurePath) 68 Mycoplasma genitalium 68 Torque teno virus 69

Trichomonas vaginalis 69

Appendix

Programme Index 70

An Introduction to the QCMD EQA Schemes


The aim of QCMD's External Quality Assessment (EQA) programmes are to help monitor and improve laboratory quality by assessing a

laboratory’s use of molecular diagnostic technologies within the routine clinical setting. The EQA schemes are both educational and

regulatory in application and support continuous quality improvement, as well as assist laboratory accreditation / certification to

ISO15189 or equivalent.

Who can participate?

The QCMD EQA programmes are open to any clinical laboratory conducting molecular based tests for the routine diagnosis of

infectious diseases. QCMD will undertake to provide the EQA service to any laboratory from any country who wishes to take

part in an EQA programme. The QCMD EQA service is offered directly or through one of QCMD many regional QA

collaborators. To register or find out more go to www.QCMD.org

The EQA programme format

All individual QCMD EQA programmes have their own design specifications which are agreed annually by QCMD in

conjunction with assigned scientific experts / expert groups. The distribution frequencies (number of challenges per year) within

an EQA programme often vary in different countries due to regional regulatory requirements. In order to help laboratories meet

their specific regional requirements the QCMD EQA programmes consist of between 1 and 4 challenges per year. Participants

can select which EQA format is best for their laboratory.

Please note: if the EQA programme format within the catalogue does not meet your specific requirements contact the QCMD

office and we will see what we can do to help you.

For more details on the format of each of the EQA programmes see the individual EQA specifications within the catalogue or

visit the QCMD website.

For example, the HIVRNA, HBV, and HCV BBV viral load EQA programmes have a quantitative focus and participants will be

able to choose either 1, 2 or 4 challenges per year. Other available formats include 1 single challenge; 2 challenges; 1 or 2

challenges.

QCMD EQA Reports & feedback

After close of the EQA results return phase, EQA participants receive an individual report generated by the Neutral Office. Individual

reports provide laboratories with an overview of their performance within an EQA challenge in relation to their method type, the

technology group they are within and where appropriate the consensus from the overall participants within the EQA programme.

On completion of the EQA programme, a supplementary report may be commissioned. The supplementary report will include

any relevant additional information regarding the recent annual EQA distribution. The supplementary reports also include

Scientific Expert commentary / feedback on the overall EQA results within that distribution. Where required, National EQA

providers or country specific EQA groups are also provided with an additional country specific EQA report.

Further information

For further details register on line and visit your profile area, download the QCMD participant manual at www.QCMD.org

http://www.qcmd.org/

http://www.qcmd.org/

EQA Groups


Bloodborne Virus

The Bloodborne 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 (B19) and more recently hepatitis A virus

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

To compliment the detection and viral load determination programme above a

range of genotyping and drug resistance BBV EQA programmes are available.

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.

B19 virus

HBV Drug Resistance

HBV Genotyping

HCV Drug Resistance

HCV Genotyping

Hepatitis A virus

Hepatitis B virus

Hepatitis C virus

Hepatitis D virus

Hepatitis E virus

HIV-1 (DNA)

HIV-1 (RNA)

HIV-1 Drug Resistance

HIV-1 Drug Resistance (Integrase)

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 immunocompromised 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.

BK virus

Borrelia burgdorferi spp.

(Lyme Disease)

Chikungunya virus

CNSI (Viral)

CNSII (Non-viral)

Dengue virus

Enterovirus

Enterovirus typing

Herpes simplex virus 1& 2

Herpes simplex virus drug resistance

JC virus

Measles / Mumps

Parechovirus

Toxoplasma gondii

Varicella-Zoster virus

West Nile virus

Zika virus

EQA 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.

CMV Drug Resistance

Extended Spectrum β-lactamase

and Carbapenemase

HBV Drug Resistance

HCV Drug Resistance

Herpes simplex virus Drug

Resistance


HIV-1 Drug Resistance (Integrase)

Methicillin Resistant Staphylococcus

aureus

Vancomycin Resistant Enterococci

EQA Groups


Exotic/Emerging Diseases

A complex relationship exists between pathogen genetics, host and the

environment. As a result predicting the future emergence of exotic diseases is

difficult. However, globalisation coupled with rapid increases in human

populations over the last 50 years has played an important role. Local

environmental changes such as deforestation due to urbanisation bring humans

into closer contact with potential new 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.

Chikungunya virus

Dengue virus

MERS coronavirus

West Nile virus

Zika 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.

Adenovirus

Bacterial

Gastroenteritis

Clostridium difficile

Diarrheagenic Escherichia coli

Helicobacter pylori

Norovirus

Parasitic Gastroenteritis

Viral Gastroenteritis

EQA 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.

Aspergillus spp.

BK virus

Candida spp.

CMV Drug Resistance

Cytomegalovirus Whole Blood

Epstein-Barr virus

Epstein-Barr virus Whole Blood

Human cytomegalovirus

Human herpes virus 6

Immunocompromised

JC virus

Pneumocystis jirovecii pneumonia

(PCP)

Toxoplasma gondii

Transplantation (viral)

Torque teno virus

Multiple Pathogen/Syndromic

Multiplex based molecular diagnostic tests offer the ability for the detection of

a wide range of pathogens within a single diagnostic test.

Syndromic approaches to test respiratory, gastroenteritis and meningitis

infections allows clinicians to identify the cause of infection from a wide range

of pathogens often in a near patient, point of impact setting where rapid

diagnosis aids faster clinical decision making and patient treatment.

These technologies are generally used as a screening approach where

identification of pathogens allow improved patient management at initial

point of contact.

QCMD have introduced multi-pathogen/syndromic programmes to address

this growing need in the clinical setting. A range of programmes cover

respiratory infections, transplant associated infections, central nervous system

infections, sexually transmitted infections and gastroenteritis infections caused

by a range of aetiologies.

Bacterial Gastroenteritis

Chlamydia trachomatis and

Neisseria gonorrhoea

CNSI (Viral)

CNSII (Non-viral)

Immunocompromised

Neonatal / Newborn infections

Parasitic Gastroenteritis

Respiratory I

Respiratory II

Respiratory III

Sepsis

Sexually Transmitted Infections I

Sexually Transmitted Infections II


Viral Gastroenteritis

EQA Groups


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.

Adenovirus

Bordetella pertussis

Chlamydophila pneumoniae

Chlamydophila psittaci

Coronavirus

Human metapneumovirus

Influenza A & B virus

Influenza Haemagglutinin Typing

Legionella pneumophila

Measles / Mumps

MERS Coronavirus

Mycobacterium tuberculosis

Mycoplasma pneumoniae

Parainfluenza virus

Pneumocystis jirovecii pneumonia

(PCP)

Respiratory syncytial virus

Rhinovirus

Respiratory I

Respiratory II

Respiratory III

Serology

Serology using the analysis of antibodies and antigens is a traditional tool in

clinical diagnostic laboratories allowing both diagnosis of infectious disease

and also determination of immunity. QCMD have designed panels based on

clinical scenarios to allow laboratories to test multiple parameters per sample to

mirror routine clinical practice.

The serology EQA range has been designed to complement the current QCMD

molecular programmes. It has been designed to monitor the performance of

laboratories using antibody and antigen tests within the routine clinical

diagnostic setting.

Blood borne virus serology

Immune status serology

Viral hepatitis serology

EQA 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

Herpes simplex virus drug resistance

Human Papillomavirus (PreservCyt)

Human Papillomavirus (SurePath)

Mycoplasma genitalium

Neisseria gonorrhoeae

Sexually Transmitted Infections I

Sexually Transmitted Infections II

Syphilis

Trichomomas vaginalis

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.

Adenovirus

BK virus

CMV Drug Resistance

Cytomegalovirus Whole Blood

Epstein-Barr virus

Epstein-Barr virus Whole Blood

Human cytomegalovirus

Human herpes virus 6

JC virus

Toxoplasma gondii


Torque teno virus

EQA 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 resistant 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.

Bacterial 16S Ribosomal RNA

typing

CMV Drug Resistance

Enterovirus Typing

HBV Drug Resistance

HBV Genotyping

HCV Drug Resistance

HCV Genotyping

Herpes simplex virus Drug

Resistance



(Integrase)

Influenza Haemagglutinin Typing

MALDI-TOF

Methicillin Resistant Staphylococcus

aureus Typing (epidemiology and

outbreak studies)

Staphylococcus aureus spa

Viral EQA


Adenovirus ADVDNA18

To assess the proficiency of laboratories in the detection and quantitation of adenovirus.

To assess the proficiency of laboratories in the detection of different adenovirus serotypes including currently circulating

serotypes of interest.

Feature Available Format(s)

Catalogue Number QAV054133_1 QAV054133_2

Total Number of Challenges 1 2

Number of Panel Members 8 to 12 4 to 6

Distribution / Testing Period Q3 Q2,Q3

Specifications

Sample NA Target Source Cultured and/or Clinical material

Matrix panel format Transport Medium and/or Plasma

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 / Frozen on Dry-ice

Accreditation/Regulatory Status Accredited to ISO17043

B19 virus B19DNA18

To assess the proficiency of laboratories in detection and quantitation of B19 virus.




Number of Panel Members 8 4


Specifications

Sample NA Target Source Clinical material

Matrix panel format Plasma

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








Viral EQA


BK virus BKDNA18

To assess the proficiency of laboratories molecular assays in detecting various types and concentrations of BK virus (BKV).

To assess the proficiency of laboratories in the reliable quantitation of BKV viral load.






Specifications


Matrix panel format Transport Medium and/or Plasma and/or Urine









Chikungunya virus CHIKV18

To assess the laboratory’s ability to detect chikungunya virus using their routine molecular diagnostic platform and procedures.


Catalogue Number QAV154175_1

Total Number of Challenges 1

Number of Panel Members 8 to 12

Distribution / Testing Period Q2

Specifications


Matrix panel format Transport Medium


Panel Member Sample Volume Lyophilised

Panel Sample Pre-treatment Requirement Reconstitution of lyophilised material

Panel Analysis type Qualitative. Quantitative for information purposes only


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

Viral EQA


CMV Drug Resistance CMVDR18

To assess the laboratories’ ability to detect CMV drug resistance mutations in kinase UL97 and polymerase UL54 genes using

sequencing techniques.






Specifications


Matrix panel format Plasma and/or Physiological Buffer

Panel Member Target Range Various mutations – kinase UL97 and polymerase UL54 genes

Panel Analysis type Sequence Analysis




Coronavirus CVRNA18

To assess the proficiency of laboratories in the detection of coronavirus.

To assess the proficiency of laboratories in the detection of different coronavirus genotypes.






Specifications






Panel Analysis type Qualitative




Viral EQA


Cytomegalovirus Dried Blood Spots CMVDBS18

To assess the performance of laboratories in the detection of clinically relevant levels of human cytomegalovirus (CMV) from

dried blood spots.






Specifications


Matrix panel format Dried Blood Spots



Panel Member Sample Volume 2 x 50µl

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



Storage / Shipment Conditions Ambient


Cytomegalovirus Whole Blood CMVWB18

To evaluate the ability of laboratories in the detection of CMV from whole blood samples.

To assess the precision of molecular assays at clinically relevant viral loads.






Specifications


Matrix panel format Whole Blood









Viral EQA


Dengue virus DENVRNA18

To assess the proficiency of laboratories in the detection of dengue virus.

To assess the proficiency of laboratories in distinguishing dengue virus from other flaviviruses.






Specifications










Enterovirus EVRNA18

To assess the ability of laboratories molecular assays to detect different types and concentrations of enterovirus (EV).

To review the performance of laboratories quantitative EV molecular assays.






Specifications

Sample NA Target Source Cultured virus and/or Clinical material









Viral EQA


Epstein-Barr virus EBVDNA18

To assess the proficiency of laboratories in the detection and quantitation of Epstein-Barr virus (EBV).






Specifications











Epstein-Barr virus Whole Blood EBVWB18

To assess the proficiency of laboratories in the detection and quantitation of Epstein-Barr virus (EBV) in whole blood samples.






Specifications


Matrix panel format Whole Blood









Viral EQA


HBV Drug Resistance HBVDR18

To assess the performance of laboratories in the detection of drug resistance mutations in the hepatitis B virus (HBV) DNA

polymerase gene using sequencing techniques and/or LiPA technology.






Specifications



Panel Member Target Range Various mutations – DNA polymerase




Storage / Shipment Conditions <-20°C / Frozen on Dry-ice Accreditation/Regulatory Status Accredited to ISO17043

HBV Genotyping HBVGT18

To assess the proficiency of laboratories in the correct genotyping of hepatitis B virus (HBV) using molecular methods.






Specifications


Genotypic Variant Various HBV genotypes





Panel Analysis type Molecular typing




Viral EQA


HCV Drug Resistance HCVDR18

To assess the performance of laboratories in the detection of drug resistance mutations in the hepatitis C virus (HCV) protease

gene using sequencing techniques.






Specifications



Panel Member Target Range Various mutations - protease (PR)






HCV Genotyping HCVGT18

To assess the proficiency of laboratories in the correct genotyping of hepatitis C virus (HCV) RNA using molecular methods.






Specifications


Genotypic Variant Various HCV genotypes and subtypes









Viral EQA


Hepatitis A virus HAVRNA18

To evaluate the ability of laboratories in the molecular detection of hepatitis A virus (HAV) in terms of sensitivity and specificity.




Number of Panel Members 8 to 10 4


Specifications










Hepatitis B virus

HBVDNA18

To assess the proficiency of laboratories in the detection and quantitation of hepatitis B virus (HBV).

To assess the proficiency of laboratories in the detection and quantitation in different HBV genotypes.


Catalogue Number QAV994110_1 QAV994110_2 QAV994110_4

Total Number of Challenges 1 2 4

Number of Panel Members 8 4 4

Distribution / Testing Period Q3 Q1,Q3 Q1,Q2,Q3,Q4

Specifications











Viral EQA


Hepatitis C virus HCVRNA18

To assess the proficiency of laboratories in the detection and quantitation of hepatitis C virus (HCV) RNA.

To assess the proficiency of laboratories in the detection and quantitation of different HCV genotypes.





Distribution / Testing Period Q3 Q1,Q3 Q1,Q2,Q3,Q4

Specifications











Hepatitis D virus HDV18

To evaluate laboratories in the detection of HDV within the routine clinical setting.






Specifications







Viral EQA


Hepatitis E virus

HEVRNA18

To evaluate the ability of laboratories in the detection of hepatitis E virus (HEV).






Specifications










Herpes simplex virus 1 & 2 HSVDNA18

To assess the ability of laboratories molecular assays to detect different types and concentrations of herpes simplex virus (HSV).

To review the performance of laboratories quantitative HSV molecular assays.






Specifications










Viral EQA


HIV-1 (DNA) HIVDNA18

To assess the proficiency of laboratories in the detection of human immunodeficiency virus type 1 (HIV-1) pro-viral DNA.




Number of Panel Members 8 4


Specifications

Sample NA Target Source Cultured proviral cells

Matrix panel format Physiological Buffer








HIV-1 (RNA) HIVRNA18

To assess the proficiency of laboratories in detection and quantitation of human immunodeficiency virus (HIV) RNA.

To assess the proficiency of laboratories in detection and quantitation in different HIV genotypes.





Distribution / Testing Period Q3 Q1, Q3 Q1, Q2, Q3, Q4

Specifications











Viral EQA


HIV-1 Drug Resistance HIVDR18

To assess the performance of laboratories in the detection of drug resistance mutations in the HIV-1 protease and reverse

transcriptase genes.






Specifications



Panel Member Target Range Various mutations - reverse transcriptase (RT) and protease (PR) genes






HIV-1 Drug Resistance (Integrase) HIVDRint18

To assess the performance of laboratories in the detection of drug resistance mutations in the HIV-1 integrase gene using

sequencing techniques.






Specifications



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






Viral EQA


Human Cytomegalovirus CMVDNA18

To assess the proficiency of laboratories in the detection and quantitation of human cytomegalovirus (CMV).






Specifications











Human Herpes virus 6 HHV6DNA18

To assess the proficiency of laboratories molecular assays in the detection of various types of human herpes virus 6 (HHV6).

To assess the proficiency of laboratories in the reliable quantitation of HHV6 viral load.






Specifications


Genotypic Variant Subtypes A and B










Viral EQA


Human Metapneumovirus MPV18

To assess the sensitivity and specificity of laboratories in the detection of human metapneumovirus (MPV).

To assess the ability of laboratories in the detection of different human MPV types.






Specifications










Human Papillomavirus (PreservCyt) HPVPRES18

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.

To assess the proficiency of laboratories in the detection of different high risk Human Papillomavirus types within a PreservCyt®

matrix.






Specifications

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


Influenza A & B virus INFRNA18

To assess the proficiency of laboratories in detection of influenza virus RNA.

To assess the proficiency of laboratories in distinguishing influenza virus A and B.






Specifications










Influenza Haemagglutinin Typing INFHT18

To assess the proficiency of laboratories in the detection of different influenza virus subtypes.

To assess the proficiency of laboratories in the typing and subtyping of influenza viruses.






Specifications




Panel Member Sample Volume 1.0ml






Viral EQA


JC virus JCDNA18

To assess the proficiency of laboratories molecular assays in detecting various types and concentrations of JC virus (JCV).

To assess the proficiency of laboratories in the reliable quantitation of JCV viral load.






Specifications











Measles / Mumps MM18

To assess the proficiency of laboratories in detection of mumps and/or measles using routine molecular methods.






Specifications


Matrix panel format Transport medium





Viral EQA


MERS Coronavirus MERS18

To assess the proficency of laboratories molecular technologies for the detection and determination of MERS-CoV from other

coronaviruses.






Specifications










Norovirus NVRNA18

To assess the specificity and sensitivity of laboratories in the detection of norovirus.

To assess the ability of laboratories in the detection of different norovirus genogroups.






Specifications


Matrix panel format Transport Medium and/or Physiological Buffer and/or Synthetic Faecal Matrix

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


Parainfluenza virus PINFRNA18

To assess the proficiency of laboratories in the detection of parainfluenza virus.

To assess the proficiency of laboratories in the detection of different parainfluenza virus types.






Specifications








Storage / Shipment Conditions <-20°C / Frozen on Dry-ice Accreditation/Regulatory Status Accredited to ISO17043

Parechovirus PeVRNA18

To assess the ability of laboratories molecular assays to detect different types and concentrations of parechovirus.






Specifications










Viral EQA


Respiratory Syncytial virus RSV18

To assess the specificity and sensitivity of laboratories in the detection of respiratory syncytial virus (RSV).

To assess the ability of laboratories in the detection of different RSV types.






Specifications










Rhinovirus RVRNA18

To assess the proficiency of laboratories in the detection of rhinovirus.

To assess the proficiency of laboratories in the detection of different rhinovirus genotypes.






Specifications










Viral EQA


Varicella-Zoster virus VZVDNA18

To assess the ability of laboratories molecular assays to detect different types and concentrations of Varicella-Zoster

virus (VZV).

To review the performance of laboratories quantitative VZV molecular assays.






Specifications










West Nile virus WNVRNA18

To assess the proficiency of laboratories in the detection of West Nile virus.

To determine the proficiency of laboratories in distinguishing West Nile virus from other flaviviruses.






Specifications










Bacterial

EQA


Bordetella pertussis BPDNA18

To assess the proficiency of laboratories in the detection of Bordetella pertussis.


Catalogue Number QAB094132_1




Specifications










Borrelia burgdorferi spp. (Lyme Disease)

BbDNA18

To assess the qualitative detection of Borrelia burgdorferi sensu stricto at different concentrations.

To assess the qualitative detection of B. burgdorferi genospecies complex at different concentrations.






Specifications


Matrix panel format Microbiological Medium and/or Transport Medium






Bacterial

EQA


Chlamydia psittaci CPS18

To assess the laboratories ability in the molecular detection of Chlamydia psittaci.






Specifications






Chlamydia trachomatis CTDNA18

To assess the qualitative performance of laboratories molecular assays in detecting Chlamydia trachomatis at various

concentrations.

To assess the ability of laboratories molecular assays to correctly identify different C. trachomatis strains.


Catalogue Number QAB004101_1 QAB004101_2




Specifications

Sample NA Target Source Cultured bacteria and/or Clinical material

Matrix panel format Urine and/or Physiological Buffer






Bacterial

EQA


Chlamydia trachomatis and Neisseria gonorrhoeae CTNg18

To assess proficiency of laboratories in the detection of Chlamydia trachomatis and Neisseria gonorrhoeae using molecular

technologies.






Specifications








Chlamydophila pneumoniae

CP18

To assess the proficiency of laboratories in the correct detection of Chlamydophila pneumoniae.






Specifications


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








Bacterial

EQA


Clostridium difficile CDDNA18

To assess the proficiency of laboratories in the molecular detection of Clostridium difficile.






Specifications


Matrix panel format Microbiological Medium and/or Synthetic Faecal Matrix







Legionella pneumophila LPDNA18

To assess proficiency of laboratories in the detection of Legionella pneumophila.






Specifications


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







Bacterial

EQA


Methicillin Resistant Staphylococcus aureus MRSADNA18

To assess the performance of laboratories in the detection of Methicillin Resistant Staphylococcus aureus.






Specifications










Methicillin Resistant Staphylococcus aureus Typing (epidemiology and outbreak studies)

MRSATP18

To assess the proficiency of laboratories in the molecular typing for outbreak analysis of Methicillin Resistant Staphylococcus

aureus.






Specifications



Panel Member Target Range Genetic variants of Staphylococcus aureus


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


Panel Testing Evaluated by various methodologies



Bacterial

EQA


Mycobacterium tuberculosis MTBDNA18

To assess the proficiency of laboratories in the molecular detection of Mycobacterium tuberculosis (M. bovis - BCG).






Specifications


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



Panel Sample Pre-treatment Requirement Routine respiratory sample treatment





Mycoplasma pneumoniae

MP18

To assess the proficiency of laboratories in the correct detection of Mycoplasma pneumoniae.






Specifications


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



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





Bacterial

EQA


Mycoplasma spp. (cell contamination) MYCO18

To evaluate current laboratory approaches for the molecular detection of Mycoplasma species.






Specifications







Neisseria gonorrhoeae NgDNA18

To assess proficiency of laboratories in the detection of Neisseria gonorrhoeae using molecular technologies.






Specifications








Bacterial

EQA


Staphylococcus aureus spa SASPA18

To assess the laboratories ability in the use of spa typing as a technique for the identification of Staphylococcus aureus.






Specifications







Syphilis SYPH18

To assess laboratories ability to detect Treponema pallidum using their routine molecular diagnostic platform and procedures.






Specifications







Fungal EQA


Aspergillus spp. ASPDNA18

To assess the qualitative detection of Aspergillus species at different concentrations.


Catalogue Number QAF104140_1




Specifications


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






Candida spp. CANDNA18

To evaluate the ability of laboratories to use molecular techniques for detection of Candida species.






Specifications


Matrix panel format Plasma and/or Physiological Buffer

Panel Member Target Range Covering clinical and analytical range





Fungal EQA


Pneumocystis jirovecii pneumonia (PCP) PCPDNA18

To assess laboratories ability in the molecular detection of Pneumocystis jirovecii.

To assess the sensitivity of molecular assays in routine clinical use for the detection of P. jirovecii.






Specifications








Parasitic EQA


Toxoplasma gondii TGDNA18

To assess the proficiency of laboratories in the qualitative detection of Toxoplasma gondii at different concentrations.


Catalogue Number QAP044123_1 QAP044123_2




Specifications


Matrix panel format Amniotic Fluid and/or Plasma








EQA pilot Studies


Bacterial 16S Ribosomal RNA B16SrRNA18

The detection of 16S rRNA by NAT and the bacterial identification by nucleic acid sequencing is an important method in clinical

cases. This is particularly relevant where there is an indication of microbial infection but the bacteria prove unculturable or

culture-negative. The technique also provides a useful method for the identification of unusual phenotypic or rare bacterial

species from various clinical sample types and those where viable bacteria may not have survived transportation or are inhibited

by antibiotic treatment. Unlike culture methods, 16S rRNA is not affected by antibiotic therapy. However, its limitations include the

difficulty in discriminating between isolates with high 16S rRNA sequence similarity (>97%) within mixed specimens, as well as the

quality and quantity of the nucleic acid material within the available clinical sample. In addition to this, the interpretation of results

can be difficult given the different database/software packages used. The panel members will resemble clinical samples and

may include current clinically relevant species of Serratia, Escherichia, Staphylococcus, Enterococcus and Klebsiella.

The aim of this EQA is to determine laboratories ability to detect, identify and interpret which bacterial species are provided within

each panel member using their routine 16S rRNA molecular diagnostic procedures.






Specifications







EQA pilot Studies


Bacterial Gastroenteritis GastroB18

Different species of pathogenic bacteria are known to cause gastroenteritis. The most common include Salmonella, Shigella,

Yersinia, Campylobacter species and various strains of toxicogenic Escherichia coli. 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 laboratories 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, E.coli 0157, C. difficile or

Campylobacter species.






Specifications


Matrix panel format Synthetic Faecal Matrix and/or Physiological Buffer





EQA pilot Studies


Central Nervous System I (Viral) CNSI18

The central nervous system I (viral) EQA pilot study will focus on the molecular detection and determination of various enterovirus,

parechovirus, herpes simplex virus 1/2, Varicella-Zoster virus and JC virus strains. The panel is designed to represent various clinical

scenarios. Participating laboratories will be expected to test each panel using their appropriate molecular methods and report

their individual test results to QCMD.

Central Nervous System II (Non-Viral) CNSII18

The central nervous system II (non-viral) EQA pilot study will focus on the molecular detection and determination of various Listeria

spp, Neisseria meningitidis, Streptococcus pneumoniae, Streptococcus agalactiae, Escherichia coli K1, Aspergillus spp. or

Haemophilus influenzae strains. The panel is designed to represent various clinical scenarios. Participating laboratories will be

expected to test each panel using their appropriate molecular methods and report their individual test results to QCMD.






Specifications







Catalogue Number QAM174196_1




Specifications






EQA pilot Studies


Dermatophytosis DERMA18

Dermatophytes is the common name for a number of fungal pathogens including Trichophyton rubrum, Trichophyton

mentagrophytes, Trichophyton tonsurans, Trichophyton violaceum, Microsporum canis, that cause difficult to treat chronic

infections of the skin, hair and nails. Traditionally microscopy is used for screening, however this is highly skilled and lacks

specificity. Culture of these organisms is prolonged and difficult taking several weeks to make a definitive laboratory diagnosis.

Nucleic acid amplification technologies (NAT) provide diagnostic tests that can rapidly confirm or exclude infection. However,

it is important to accurately distinguish between different species to guide appropriate antifungal treatment. The diverse

specimen types routinely received in clinical laboratories bring issues surrounding sample preparation and carefully controlled

laboratory conditions are essential. Consideration of inhibition due to previous drug treatments and other substances is also

essential to prevent both false positive and negative results.

The aim of this EQA is to assess laboratories ability to detect dermatophytes using their routine molecular diagnostic platform

and procedures.






Specifications







EQA pilot Studies


Diarrheagenic Escherichia coli E.COLI18

Escherichia coli is the predominant nonpathogenic facultative flora of the human intestine. Whilst most strains of E. coli normally

remain harmless to the human host, some strains have evolved the ability to cause a broad spectrum of human diseases.

Diarrheagenic strains of E. coli can be divided into several distinct categories on the basis of their pathogenic features.

Diarrheagenic E. coli infection is a major cause of morbidity and mortality worldwide, meaning the swift detection of these

pathogens is extremely important. The aim of this EQA pilot study is to assess laboratories ability to detect diarrheagenic E. coli

strains using their routine molecular diagnostic platform and procedures.






Specifications







EQA pilot Studies


Enterovirus Typing EVTP18

Whilst the Global Polio Eradication Initiative has made great progress, other picornaviruses, including enteroviruses (EV) and

parechoviruses (HPeV) are growing in clinical importance. Enteroviruses are associated with outbreaks of serious disease, resulting

in considerable morbidity and occasional mortality. These viruses cause a wide variety of diseases and it is known that non-polio

enteroviruses are the most common cause of aseptic meningitis in adults as well as children. In the Asia-Pacific region, repeated

outbreaks of EV71 have led to an increase in the incidence of hand, foot and mouth disease (HFMD) with concurrent fatal

encephalitis among very young children. Therefore, monitoring enterovirus infections, and providing laboratory confirmation of

the types associated with different presentations, is of significant public health value.

Laboratory detection of EV is normally through RT-PCR assays targeted at the highly conserved 5’ non-coding EV genomic region,

which does not provide specific information regarding the particular EV type involved. Yet, molecular typing of EV is increasingly

important to ensure that EV and polio viruses are not re-introduced into countries where they have been eradicated, to identify

the cause of a new outbreak, and for general surveillance and epidemiological purposes.

The aim of this EQA pilot study is to assess laboratories ability to correctly identify specific enterovirus types using their routine

molecular method and procedures.






Specifications








EQA pilot Studies


Extended Spectrum ß-lactamase and Carbapenemase ESBL18

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.






Specifications


Genotypic Variant Various drug resistance strains





EQA pilot Studies


Group B Streptococcus GBS18

Group B Streptococcus (Streptococcus agalactiae) is a bacteria commonly found in the gastro-intestinal and vaginal tract of

healthy individuals. Streptococcus agalactiae is an opportunistic pathogen which has the potential to cause serious life

threatening infections in susceptible individuals, particularly newborn babies who can be infected during and post-delivery.

Infected newborns can develop sepsis, pneumonia or meningitis.

Molecular diagnostic methods are used as they allow rapid turnaround times for screening of expectant mothers and early

diagnosis of newborns which allows for timely administration of antibiotics.

The group B Streptococcus EQA pilot study aims to determine laboratories ability in the qualitative detection of group B

Streptococcus using their routine molecular diagnostic procedures.






Specifications






EQA pilot Studies


Helicobacter pylori H.PYLORI18

Helicobacter pylori is a Gram-negative bacterium found primarily in the stomach. It is associated with Peptic Ulcer Disease (PUD)

and various types of gastric cancer. Chronic H. pylori infections are endemic and affect approximately 50% of the world’s

population. The prevalence of H. pylori has been shown to be closely linked to socioeconomic factors and economic status

primarily within emerging countries. Many different tests have been used to detect H. pylori infection. These include both invasive

histology as well as non-invasive serological methods such as the stool antigen test (SAT). In recent years the use of molecular

methods for the detection of H. pylori has increased significantly. This is largely due to the increased sensitivity and specificity that

molecular methods offer particularly in patients with upper gastrointestinal bleeding (UGIB) and suspected H. pylori infection.

Molecular methods have also been shown to be a reliable and useful (non-invasive) test for the detection of H. pylori in stool

samples as well as the determination of different genotypes vacA and cagA from gastric biopsy samples (invasive). More recently

molecular methods have also been used in the detection of resistance to antibiotics such as clarithromycin.

The aim of this EQA is to determine laboratories ability in the qualitative detection of H. pylori and where appropriate, the

identification of H. pylori antibiotic resistance status using their routine molecular diagnostic procedures.






Specifications







EQA pilot Studies


Herpes simplex virus drug resistance HSVDR18

Herpes simplex virus (HSV) causes a wide spectrum of clinical manifestations in the central nervous system (CNS). Early intervention

is essential to allow efficient treatment of HSV infections with antiviral drugs, such as acyclovir, valacyclovir and famciclovir.

However, of particular concern in the treatment of HSV infection is the growing incidence of drug resistance.

Drug-resistance HSV disease is rare in the general population but is of concern in immunocompromised patients and, in particular,

bone marrow and stem cell transplant patients. Prolonged use of acyclovir in the treatment of HSV is an important risk factor in

HSV resistance, although drug-resistant HSV has been isolated in the absence of known acyclovir exposure.

HSV resistance is related to viral thymidine kinase (TK) and DNA polymerase mutations. In >90% of cases, acyclovir resistance is

associated with a mutation in the TK gene as this enzyme is not essential for viral replication, unlike viral DNA polymerase, which is

rarely involved in resistance. Strains resistant to acyclovir are almost always cross-resistant to other TK-dependent drugs, such as

penciclovir and famciclovir. Mutations in the TK gene are often due to addition or deletion of nucleotides in homopolymer runs of

guanines and cytosines, resulting in frameshifting and loss of TK function. Given the essential role of viral DNA polymerase in viral

replication, mutations in this gene occur less frequently and are mainly located in conserved sites of the enzyme, such as

functional domains II and III.

Acyclovir-resistant HSV strains are normally sensitive to foscarnet and cidofovir, but HSV resistance to these treatments has also

been reported.

The aim of the HSV Drug Resistance EQA pilot programme is to assess laboratories ability to detect HSV drug resistance mutations

using their routine molecular platform and procedures.






Specifications

Sample NA Target Source Cultured material and/or Clinical material


Panel Member Target Range Various mutations - Thymidine Kinase (UL23) and DNA polymerase (UL30)

genes Panel Member Sample Volume 1.0 ml




EQA pilot Studies


Immunocompromised IC18

The immunocompromised EQA pilot study will focus on the molecular detection and determination of various Toxoplasma gondii,

Pneumocystis jirovecii, Aspergillus spp. Candida albicans and JC virus strains. The panel is designed to represent various clinical








Specifications






EQA pilot Studies


MALDI-TOF MALDI18

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 and fungal 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

and fungal 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 and fungal 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 isolates using MALDI-TOF and other similar mass spectrometry based technologies in the routine microbiology laboratory.






Specifications

Sample NA Target Source Cultured material and/or Clinical material


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

Panel Analysis type Typing



EQA pilot Studies


Neonatal / Newborn infections NEO18

The neonatal EQA pilot study will focus on the molecular detection and determination of various cytomegalovirus, enterovirus,

parechovirus, herpes simplex virus 1/2, Toxoplasma gondii, Group B Streptococcus strains. The panel is designed to represent

various clinical scenarios. Participating laboratories will be expected to test each panel using their appropriate molecular

methods and report their individual test results to QCMD.






Specifications






EQA pilot Studies


Parasitic Gastroenteritis GastroP18

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 laboratories' 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.


Catalogue Number QAP124154_1




Specifications







Respiratory I RESPI18

The Respiratory I pilot EQA will focus on the molecular detection and determination of various influenza A & B and respiratory

syncytial virus strains. The panel is designed to represent various clinical scenarios. Participating laboratories will be expected to

test each panel using their appropriate molecular methods and report their individual test results to QCMD.






Specifications








EQA pilot Studies


Respiratory II

RESPII18

The Respiratory II pilot EQA will focus on the molecular detection and determination of human metapneumovirus, respiratory

adenoviruses, rhinoviruses , coronaviruses, enterovirus and parainfluenza viruses. The panel is designed to represent various clinical








Specifications








Respiratory III RESPIII18

The Respiratory III EQA pilot study will focus on the molecular detection and determination of various Bordetella pertussis, Legionella

pneumoniae, Mycoplasma pneumoniae, Streptococcus pneumoniae or Haemophilus influenzae strains. The panel is designed to

represent various clinical scenarios. Participating laboratories will be expected to test each panel using their appropriate molecular

methods and to report their individual test results to QCMD.






Specifications




Panel Member Sample Volume 1.0ml




EQA pilot Studies


Sepsis SEPSIS18

Sepsis is a common and potentially life-threatening condition triggered by infection. Sepsis develops due to the overproduction

of immune responses such as inflammation, swelling and even blood clotting. Severe sepsis is the most common reason for

admission to intensive care. Mortality related to sepsis remains high and despite improving healthcare outcomes it is the second

leading cause of death in non-coronary intensive care. In addition, patients who survive severe sepsis can often be left with

physical and cognitive impairment and have a 50% increased risk of mortality in the 5 years after sepsis. There are many risk

factors associated with the development of severe sepsis, including patient's predisposition to infection, chronic disease

including immunodeficiency diseases, cancer as well as immunosuppressive treatment. In recent years the inappropriate use of

antimicrobial drugs has also been a major concern and has been related to an increase in reported sepsis mortality. The

reasons for this include the antimicrobial resistance in nosocomial infections. As a result, there has been a growing interest in the

development of rapid diagnostics for the early identification of bloodstream infections to allow a more targeted approach to

therapy, particularly in critically ill patients. Blood culture has always been considered as the gold standard for the diagnosis

and identification of bloodstream infections. However, blood culture lacks sensitivity and the delay in the time to patient result

reporting has a negative impact on patient treatment.

The molecular detection of sepsis increases the speed of diagnosis and improves sensitivity leading to more widespread clinical

use. However, molecular methods are still susceptible to sensitivity issues and the risk of false positive results, which can have an

impact on the clinical decision making process.

This EQA pilot study may consist of a range of pathogens associated with sepsis such as Staphylococcus, Serratia, Escherichia

coli, Enterococcus, Streptococcus, Klebsiella, coagulase-negative Staphylococcus, and Pseudomonas spp. The participating

laboratory will be required to use their current molecular diagnostic processes and procedures for the detection and

identification of microorganisms within blood or plasma based matrices.






Specifications


Matrix panel format Whole Blood and/or Plasma





EQA pilot Studies


Sexually Transmitted Infections I STI_I18

Rates of sexually transmitted infections remain high despite diagnostic and therapeutic advances. A number of pathogens in

addition to Chlamydia trachomatis, Neisseria gonorrhoea and Treponema pallidum (Syphilis) have been implicated in genital

infections in both men and women; however, many of the conventional detection techniques lack sensitivity and specificity for

accurate diagnosis.

The aim of this Sexually Transmitted Infection (STI) EQA is to assess the laboratories ability to detect a range of sexual transmitted

infections known to cause disease using their routine molecular diagnostic platform and procedures. The panel members will

resemble clinical samples and may include current clinically relevant strains of Mycoplasma genitalium, Mycoplasma hominis,

Trichomonas vaginalis, Ureaplasma urealyticum and Gardnerella vaginalis.






Specifications







Sexually Transmitted Infections II STI_II18

The sexually transmitted infection II EQA pilot study will focus on the molecular detection and determination of various Chlamydia

trachomatis, Neisseria gonorrhoeae, Treponema pallidum, and herpes simplex virus strains. The panel is designed to represent

various clinical scenarios. Participating laboratories will be expected to test each panel using their appropriate molecular methods

and to report their individual test results to QCMD.






Specifications







EQA pilot Studies


Transplantation (Viral)

TRANS18

The viral transplant EQA pilot study will focus on the molecular detection and determination of various cytomegalovirus, Epstein-

Barr virus, human herpes virus 6, BK virus and adenovirus strains. The panel is designed to represent various clinical scenarios.

Participating laboratories will be expected to test each panel using their appropriate molecular methods and to report their

individual test results to QCMD.

Vancomycin Resistant Enterococci VRE18

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.






Specifications


Genotypic Variant Various Drug resistance strains










Specifications






EQA pilot Studies


Viral Gastroenteritis GastroV18

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 laboratories 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, astrovirus, sapovirus and adenovirus.






Specifications







EQA pilot Studies


Zika Virus ZIKA18

Zika virus is a mosquito-borne flavivirus that was first identified in Uganda in 1947. The increased incidence of Zika virus in South

America and its spread around the world is a major public health concern, particularly for pregnant women living and traveling

to affected areas. Zika virus infection in the majority of cases is a mild self-limiting illness, however serious complications have

been observed in recent outbreaks such as Guillain-Barré syndrome and microcephaly in newborn babies born to infected

mothers. Molecular diagnostic protocols such as PCR are recognised as a primary tool in the testing for flaviviruses. This pilot

EQA scheme will assess the proficiency of laboratories in the detection of Zika virus and determine the proficiency of

laboratories in distinguishing Zika virus from other flaviviruses.






Specifications









Serology pilot studies


Serology Introduction

The QCMD Serology EQA range complements the QCMD current 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 will focus on three principal areas:

• Bloodborne Virus

• Viral Hepatitis

• Immune Status

Each serology programme will consist of two challenges per year with four to six panel members per challenge. 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

challenge, 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, laboratories within the serology EQA programmes will be

able to report their results electronically through QCMD’s online 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.

Bloodborne virus serology BBVSERO18

This programme covers a wide variety of bloodborne virus serological markers for HIV, HCV, HBV and HTLV. Within each challenge

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.


Catalogue Number QAS144172_2



Distribution / Testing Period Q1,Q3

Specifications

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




Immune status serology ISSERO18

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 challenge there will be different

serological markers presented within the panel. The 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.






Specifications


Parameters HAV: antiHAV (total)

HBV: antiHBs

MMR: mumps, measles, rubella antibodies

STD : antibodies to HSV-2, C. trachomatis, T. pallidum

Tx : antibodies to CMV, EBV, T. gondii

Pregnancy : B19, CMV, VZV, T. gondii










Viral hepatitis serology VHSERO18

This programme covers 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 challenge there will be different markers presented within the panel.






Specifications


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)








New Molecular EQA Pilot Studies 2018


Human Papillomavirus (SurePath) HPVSURE18

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.

To assess the proficiency of laboratories in the detection of different high risk Human Papillomavirus types within a SurePath™

matrix.

Mycoplasma genitalium MG18

Mycoplasma genitalium is a small pathogenic bacteria which causes urethritis in both men and women, and also cervicitis

and pelvic inflammation in women. M. genitalium has been identified as a co-factor in the increased risk of HIV transmission.

Infection with M. genitalium is fairly common however can be easily treated with antibiotics.

The aim of the Mycoplasma genitalium EQA pilot study is to assess laboratories ability to detect Mycoplasma genitalium using

routine molecular diagnostic platform and procedures.






Specifications

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

Matrix panel format Transport Medium (SurePath)










Specifications






New Molecular EQA Pilot Studies 2018


Torque teno virus TTV18

Torque teno virus (TTV) is the most abundant component of the human virome and is almost endemic worldwide. TTV has been

classed as an orphan virus, where it is able to establish chronic infections without causing overt pathology. TTV viremia is increased

in immunosuppressed hosts, and has been shown to induce immune responses and cytokine production and secretion. Therefore,

it has been suggested the measurement of TTV viral load following treatment could be useful to gauge the efficacy of

immunosuppression.

The aim of the Torque Teno Virus (TTV) EQA pilot study is to assess laboratories ability to detect TTV using routine molecular

diagnostic platform and procedures.

Trichomonas vaginalis TV18

Trichomonas vaginalis is the most common pathogenic parasitic infection in humans, residing in the genital tract and

responsible for the sexually transmitted infection trichomoniasis. Although trichomoniasis can be asymptomatic, inflammation

of the genitals is one of the main symptoms and may increase the risk of transmission of HIV. Trichomoniasis can be treated

effectively with antibiotics however, rare complications can occur during pregnancy, including premature birth and low birth

weight.

The aim of the Trichomonas vaginalis EQA pilot study is to assess laboratories ability to detect Trichomonas vaginalis using

routine molecular diagnostic platform and procedures.






Specifications







Catalogue Number QAP184202_1




Specifications







Appendix

Viral EQA

Programme

Code Programme Description Groupings

Catalogue

Number

Available

Formats/

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)/

Testing Period

Shipping

Conditions Analysis Type

Page

Number

ADVDNA18 Adenovirus

QAV054133_1 1 8 to 12 Q3

Dry-ice Qual & Quant 13 QAV054133_2 2 4 to 6 Q2,Q3

B19DNA18 B19 virus QAV034116_1 1 8 Q3

Dry-ice Qual & Quant 13 QAV034116_2 2 4 Q1,Q3

BKDNA18 BK virus

QAV144166_1 1 8 to 12 Q3


CHIKV18 Chikungunya virus

QAV154175_1 1 8 to 12 Q2 Ambient Qual 14

CMVDR18 CMV Drug Resistance

QAV144169_1 1 4 to 7 Q2 Dry-ice Drug

Resistance /

Sequencing

15

CVRNA18 Coronavirus

QAV064137_1 1 8 to 12 Q2 Dry-ice Qual 15

CMVDBS18 Cytomegalovirus Dried Blood Spots


CMVWB18 Cytomegalovirus Whole Blood QAV124150_1 1 8 to 12 Q3


DENVRNA18 Dengue virus


EVRNA18 Enterovirus QAV984104_1 1 8 to 12 Q3

Dry-ice Qual 17 QAV984104_2 2 4 to 6 Q1,Q3

EBVDNA18 Epstein-Barr virus

QAV024121_1 1 8 to 12 Q3


EBVWB18 Epstein-Barr virus Whole Blood

QAV134161_1 1 8 to 12 Q3


HBVDR18 HBV Drug Resistance


Resistance /

Sequencing

19

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HBVGT18 HBV Genotyping

QAV064118_1 1 8 to 12 Q1 Dry-ice Typing 19

HCVDR18 HCV Drug Resistance


Resistance /

Sequencing

20

HCVGT18 HCV Genotyping


HAVRNA18 Hepatitis A virus

QAV124156_1 1 8 to 10 Q3


HBVDNA18 Hepatitis B virus

QAV994110_1 1 8 Q3


QAV994110_4 4 4 Q1, Q2, Q3,Q4

HCVRNA18 Hepatitis C virus

QAV994112_1 1 8 Q3


QAV994112_4 4 4 Q1, Q2, Q3,Q4

HDV18 Hepatitis D virus

QAV144170_1 1 8 to 10 Q3 Dry-ice Qual & Quant 22

HEVRNA18 Hepatitis E virus


HSVDNA18 Herpes simplex virus 1& 2

QAV994105_1 1 8 to 12 Q3


HIVDNA18 HIV-1 (DNA)

QAV034114_1 1 8 Q3

Dry-ice Qual 24 QAV034114_2 2 4 Q1,Q3

HIVRNA18 HIV-1 (RNA)

QAV994108_1 1 8 Q3


QAV994108_4 4 4 Q1, Q2, Q3,Q4

HIVDR18 HIV-1 Drug Resistance


Resistance /

Sequencing

25

HIVDRint18 HIV-1 Drug Resistance (Integrase)


Resistance /

Sequencing

25

CMVDNA18 Human Cytomegalovirus

QAV014120_1 1 8 to 12 Q3


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HHV6DNA18 Human Herpes virus 6 QAV084119_1 1 8 to 12 Q3


MPV18 Human Metapneumovirus


HPVPRES18 Human Papillomavirus (PreservCyt) QAV094130_1 1 8 to 12 Q4 Ambient /

Specialist Qual 27

QAV094130_2 2 4 to 6 Q2,Q4

INFRNA18 Influenza A & B virus

QAV054134_1 1 8 to 12 Q4


INFHT18 Influenza Haemagglutinin Typing


JCDNA18 JC virus

QAV074106_1 1 8 to 12 Q3


MM18 Measles / Mumps


MERS18 MERS Coronavirus


NVRNA18 Norovirus

QAV084139_1 1 8 to 12 Q4


PINFRNA18 Parainfluenza virus


PeVRNA18 Parechovirus QAV114145_1 1 8 to 12 Q3


RSV18 Respiratory Syncytial virus QAV054142_1 1 8 to 12 Q4


RVRNA18 Rhinovirus


VZVDNA18 Varicella-Zoster virus

QAV034103_1 1 8 to 12 Q3


WNVRNA18 West Nile virus


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Bacterial EQA

Programme


Catalogue

Number

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)

Shipping

Conditions

Analysis Type

Page

Number

BPDNA18 Bordetella pertussis

QAB094132_1 1 8 to 12 Q2 Dry-ice Qual 34

BbDNA18 Borrelia burgdorferi spp. (Lyme

Disease)


CPS18 Chlamydia psittaci


CTDNA18 Chlamydia trachomatis

QAB004101_1 1 8 to 12 Q3

Dry-ice Qual 35 QAB004101_2 2 4 to 6 Q1,Q3

CTNg18 Chlamydia trachomatis and

Neisseria gonorrhoeae


QAB174191_2 2 4 to 6 Q3, Q1

CP18 Chlamydophila pneumoniae


CDDNA18 Clostridium difficile

QAB084125_1 1 8 to 12 Q4


LPDNA18 Legionella pneumophila


MRSADNA18 Methicillin Resistant S. aureus

QAB064124_1 1 8 to 12 Q2 Ambient Qual 38

MRSATP18 Methicillin Resistant S. aureus Typing (epidemiology and outbreak studies)

QAB074128_1 1 8 to 12 Q2 Ambient Typing 38

MTBDNA18 Mycobacterium tuberculosis QAB014129_1 1 8 to 12 Q4

Ambient Qual 39 QAB014129_2 2 4 to 6 Q2, Q4

MP18 Mycoplasma pneumoniae


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Fungal EQA

Parasitic EQA

MYCO18 Mycoplasma spp.

(cell contamination)

QAB144168_1 1 8 to 12 Q4 Dry-ice Qual & Quant 40

NgDNA18 Neisseria gonorrhoeae

QAB034126_1 1 8 to 12 Q3


SASPA18 Staphylococcus aureus spa


SYPH18 Syphilis


Programme


Catalogue

Number

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)

Shipping

Conditions

Analysis Type

Page

Number

ASPDNA18 Aspergillus spp.

QAF104140_1 1 8 to 12 Q3 Dry-ice Qual 42

CANDNA18 Candida spp.


PCPDNA18 Pneumocystis jirovecii pneumonia

QAF114144_1 1 8 to 12 Q3 Dry-ice Qual & Quant 43

Programme


Catalogue

Number

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)

Shipping

Conditions

Analysis Type

Page

Number

TGDNA18 Toxoplasma gondii QAP044123_1 1 8 to 12 Q4

Ambient Qual 44 QAP044123_2 2 4 to 6 Q2,Q4

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EQA Pilot Studies

Programme


Catalogue

Number

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)

Shipping

Conditions

Analysis Type

Page

Number

B16SrRNA18 Bacterial 16S Ribosomal RNA

QAB164183_1 1 8 to 10 Q4 Dry-ice Typing 45

GastroB18 Bacterial Gastroenteritis


CNSI18 CNSI (Viral)


CNSII18 CNSII (Non-viral)

QAM174196_1 1 8 to 12 Q4 Dry-ice Qual 47

DERMA18 Dermatophytosis


E.COLI18 Diarrheagenic Escherichia coli


EVTP18 Enterovirus Typing


ESBL18 Extended Spectrum ß-lactamase

and Carbapenemase


GBS18 Group B Streptococcus


H.PYLORI18 Helicobacter pylori


HSVDR18 Herpes Simplex virus drug resistance


Resistance /

Sequencing

54

IC18 Immunocompromised


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MALDI18 MALDI-TOF


NEO18 Neonatal / Newborn infections


GastroP18 Parasitic Gastroenteritis

QAP124154_1 1 8 to 12 Q4 Dry-ice Qual 58

RESPI18 Respiratory I


RESPII18 Respiratory II


RESPIII18 Respiratory III


SEPSIS18 Sepsis


STI_I18 Sexually Transmitted Infections I


STI_II18 Sexually Transmitted Infections II


TRANS18 Transplantation (Viral)

QAM174198_1 1 8 to 12 Q3 Dry-ice Qual & Quant 62

VRE18 Vancomycin Resistant Enterococci


GastroV18 Viral Gastroenteritis


ZIKA18 Zika virus


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Serology EQA Pilot Studies

New Molecular EQA Pilot Studies for 2018

Programme


Catalogue

Number

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)

Shipping


Page

Number

BBVSERO18 Bloodborne virus serology

QAS144172_2 2 4 to 6 Q1,Q3 Dry-ice Qual 65

ISSERO18 Immune status serology


VHSERO18 Viral hepatitis serology


Programme


Catalogue

Number

No. of

Challenges

Panel

Members

per

challenge

Distribution

Date(s)

Shipping


Page

Number

HPVSURE18 Human Papillomavirus (SurePath) QAV184204_1 1 8 to 12 Q4

Ambient Qual 68 QAV184204_2 2 4 to 6 Q2, Q4

MG18 Mycoplasma genitalium


TTV18 Torque teno virus


TV18 Trichomonas vaginalis

QAP184202_1 1 6 to 10 Q4 Dry-ice Qual 69

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Version number CAT2018/02€¦ · Viral Gastroenteritis 63 Zika Virus 64 Serology EQA Pilot Studies...

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Transcript of Version number CAT2018/02€¦ · Viral Gastroenteritis 63 Zika Virus 64 Serology EQA Pilot Studies...