2023 NRL EQAS Catalogue

2023 NRL External Quality Assessment Schemes
INDEX
NRL - About Us 3
What's New in 2023? 4
System Overview 5
The First Principle 6
Why Results Deadlines Matter 7
Serology EQAS 8
o Multimarker Blood Screening Serology 9

o Hepatitis Serology 9
o Retrovirus and Syphilis Serology 10
o Torch and EBV Serology 10
o SARS-CoV-2 Antibodies 11
Molecular EQAS 12
o Multimarker Blood Screening Molecular 13

o Multimarker Plasma Fractionation Molecular 13
o Viral Exanthems Molecular 14
o Viral Respiratory Molecular 14
o Extended Viral Respiratory Molecular 15
o Bacterial Plus Respiratory Molecular 15
o Sexually-Transmitted Infections Molecular 16
o HIV Molecular 16
o HBV Molecular 17
o HCV Molecular 17
o HPV Molecular 18
o CMV Molecular 18
Point-of-Care and Specialised EQAS 19
o C. trachomatis, N. gonorrhoeae & T. vaginalis Molecular POC 20

o Dried Tube Sample HIV and Early Infant Diagnosis Molecular POC 20
o Dried Tube Sample HBV Molecular POC 21
o Dried Tube Sample HCV Molecular POC 21
o HTLV Molecular 22
o Leptospirosis Molecular 22
o Mycobacterium Molecular POC 23
NRL - ABOUT US
NRL, as a World Health Organization (WHO)

Collaborating Centre, is a Melbourne-based scientific
organisation that exists to promote the quality of tests
and testing for infectious diseases globally.
Accreditation:
NRL is accredited for compliance with ISO/IEC 17043 as a proficiency testing provider
Accreditation Number 14253
NRL is certified to ISO 9001, Quality Management

Systems
Certification number FS 605059
NRL offers the following two major types of External Quality Assessment Schemes (EQAS):
Comprehensive EQAS:
• Designed for sophisticated laboratory-based testing as well as testing in low/middle-income

countries using high throughput automated testing platforms.
Point-of-Care (POC) EQAS:
• Designed for near-patient molecular and rapid serology tests often utilised by low-income countries,
remote and regional communities, and primary care testing sites.
In partnership with Oneworld Accuracy (www.oneworldaccuracy.com) and its extensive network

of collaborators, all NRL EQAS are supported by OASYS, an Internet-based software management
system. NRL EQAS are distributed to testing facilities in over 50 countries, enabling monitoring
and peer comparison for a range of test kits and instrumentation. Our programs
incorporate genuine and diverse samples and are intended to assess the integrity of the entire testing
process.
The design and analysis of both Comprehensive and POC EQAS draw upon NRL’s extensive
experience and scientific methods to ensure maximum scope for error detection. NRL staff
detect and review unexpected EQAS submitted results and work with the participants and
corresponding test kit manufacturers (as applicable) to determine and resolve the root cause of any
issues that would have otherwise potentially resulted in misdiagnosis.
3
WHAT'S NEW IN 2023?
• NRL is expanding the Respiratory Molecular offering in 2023 and launching two new programs:
o Extended Viral Respiratory Molecular Program (RESV435) and Bacterial Plus Respiratory
Molecular Program (RESB435).
o Influenza A Genotyping into the existing Viral Respiratory Molecular Program (RESP435).
o The three programs cover most analytes for respiratory molecular testing.
• CMV Molecular Program (CMVN435) is being re-introduced in 2023:

o The program is designed for laboratories which perform viral load and/or qualitative CMV molecular
testing on plasma samples.
• Improved the SARS-CoV-2 Antibodies Program (COVS435/432) for 2023 with two panel sizes:
o This program is now designed and managed by NRL.
o Unique individual samples from single donors and enhanced assessment.
• HIV Molecular Program (HIVL435), HBV Molecular Program (HBVL435) and HCV Molecular Program
(HCVQ435):
o Now assess both quantitative results (Viral Load) and qualitative results (Detection).
o Increase sample volume of all three programs to 1.4 mL.
• Sexually-Transmitted Infections Molecular Program (STIC435)now includes:

o An additional Drug Resistant strain: Mycoplasma genitalium Azithromycin Resistant.
v HPV Molecular Program (HPVN435) now:

o Contains a greater variety of other HPV High Risk Types.
o Group or individual HPV genotyping results can be reported in the program.
• Mycobacterium Molecular POC Program (MTBN435) now:

o Contains more Drug Resistant Strains.
o A Variety of TB drug resistant results can be reported in the program.
• SARS-CoV-2 Antigen Program (COVA434) is being discontinued in 2023.

o Please contact NRL if you need quality assurance programs for SARS-CoV-2 Antigen Testing.
For any additional queries, we are here to answer your questions:
E: [email protected]
T: +61 3 9418 1124
4
SYSTEM OVERVIEW
Getting started
Programs are listed by discipline. To order programs, please use the Order Form on NRL's website or contact NRL
directly for a quote.
The Test Event Cycle
Shipment Notice
Receive These remind you that a shipment will be arriving soon.
Samples
Test Event Reminder

These enable you to prepare for the upcoming Test Event.
Test Samples Instructions + Worksheets

+ These enable you to properly receive, store and test your
samples and record submitted results.
Submit Results
Results Deadline Reminders

These remind you to submit all results before the Results
Deadline.
Receive Performance Reports

Assessment
These summarise your performance.
Here's how we acknowledge your commitment to testing quality
For EQA schemes, we provide an annual Certificate of Participation listing the disciplines of all programs you
participated in.
5
THE FIRST PRINCIPLE
Program = Patient
Samples Samples
When you participate in NRL EQAS, the First Principle is that you must test program samples and report results
exactly as you would patient samples.
Our programs are designed to assess how you test patient samples and report results. They are intended to be
educational in nature so that if problems are identified, they represent an opportunity for you to improve the
quality of your patient testing. We strive to help you so that all of your patients receive accurate, clinically
relevant and timely results.
Your commitment to the First Principle ensures that our programs can be a reliable measure for how you test
patient samples and report results. This means you must:
test samples in the same manner and number of times as you test patient samples;
test samples within the same timeframes as you test patient samples;
test samples by the same personnel that routinely test patient samples;
test samples using the same systems used to routinely test patient samples;
submit results within the same timeframes as you report patient results; and
not discuss your results with other participants or send your samples for outside testing.
6
WHY RESULTS DEADLINES MATTER
Submitting results before the signals your commitment to the First Principle.
For consistency, all Results Deadlines are on the Test Event date and end at 11:59 pm (23:59) your local time.
Submitting on time enables us to evaluate and communicate your performance as soon as possible.
To give you ample time, all programs have Test Event Windows that exceed routine testing times for patient
samples. The system reminds you of missing results and Results Deadlines. As well, the system helps you meet
Results Deadlines:
To encourage early submission, the system records when your results are submitted and calculates your Turn-
Around-Time measured in days before the Results Deadline.
To discourage late submission, the system does not accept your results if submitted after the Results Deadline.
To fix clerical errors, the system accepts all changes to your submitted results anytime before the Results
Deadline.
Our Program Codes give you Program Details
HEPM435 Number of samples
Number of Test Events

Name of the program
4 = EQA
7
SEROLOGY EQAS
2023 Test Event Calendar
The following Test Event Calendar applies for all Programs in the Serology EQAS section.
Test Event Test Event Open Test Event Window Results Deadline
1 29 March 2023 23 days 21 April 2023
2 28 June 2023 21 days 19 July 2023
3 27 September 2023 21 days 18 October 2023
8
SEROLOGY EQAS
1. MULTIMARKER BLOOD SCREENING SEROLOGY

UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SAMPLE TYPE: Liquid human plasma SHIPPING CODE: 3373
PROGRAM CODE FORMAT COMPATIBILITY
MMBS4310
3 Test Events x 10 samples x 1.8 mL Participants can report multiple runs and replicates for
multiple analyzers or methods.
3 shipments Not compatible with Non-Treponemal detection methods.
HIV p24 Ag HCVAg HBsAg Anti-HTLV

Anti-HIV Anti-HCV Anti-HBc Total Anti-Treponema pallidum
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform blood and tissue
screening serology for infectious diseases.
Science - The MMBS4310 EQA program is the only ISO 17043 accredited infectious disease blood and tissue screening serology
program that offers samples representative of those normally tested in routine blood screening facilities and now includes anti-
HTLV. To maintain both affordability and scientific integrity, we offer the panel size of 10 samples per Test Event. To ensure sufficient
sample volume for testing for multiple analytes and multiple assays, we offer the volume of 1.8 mL per sample. We use
undiluted human plasma or pooled plasma samples in this program. We redesigned our Test Event assessments to
shorten the turnaround times with the inclusion of custom-tailored comments to support troubleshooting and
graphical reports to enhance comparisons within and between peer groups. This program meets the highest international quality
standards.
2. HEPATITIS SEROLOGY
UN
HEPM435
3 shipments multiple analyzers or methods.
Anti-HAV IgG HBsAg Anti-HBs HCVAg

Anti-HAV IgM Anti-HBc Total HBeAg Anti-HCV
Anti-HAV Total Anti-HBc IgM Anti-HBe Anti-HDV
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform serology testing for
hepatitis markers using automated testing platforms, manual assays and rapid tests.
Science - We created sample sets to cover all serology analytes relevant to hepatitis testing, expanding our analyte offering to
include anti-HDV. To improve affordability while maintaining scientific integrity, we offer 5 samples per Test Event. To ensure sufficient
sample volume for testing for multiple analytes and multiple assays, we offer the volume of 1.8 mL per sample. We use undiluted
human plasma or pooled plasma samples in this program. We redesigned our Test Event assessments to shorten the turnaround
times with the inclusion of custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons
within and between peer groups. This program is ISO 17043 accredited and meets the highest international clinical standards.
9
SEROLOGY EQAS
3. RETROVIRUS AND SYPHILIS SEROLOGY

UN
RVSS435
HIV p24 Ag Anti-Treponema pallidum Anti-HTLV

Anti-HIV Non-Treponemal antibodies
DESCRIPTION
Application – We designed this as a comprehensive, cost-effective EQA program for laboratories that perform serology testing for HIV,
HTLV and Syphilis. We combined anti-HIV, HIV p24, anti-HTLV, anti-Treponema and Non-Treponemal antibodies into a
single, convenient program. This program replaced single analyte programs HTLV, HIVC and TREP and presents excellent
value compared to multiple single analyte programs.
Science – Clinicians routinely screen for HIV, HTLV and Syphilis serology together in one test request. We created sample sets to
mimic the clinical need, with coverage of these three pathogens. Laboratories can submit results from multiple assays across
the entire testing algorithm for multiple analytes. To improve affordability while maintaining scientific integrity, we offer 5
samples per Test Event. To ensure sufficient sample volume for testing for multiple analytes and multiple assays, we offer the
volume of 1.8 mL per sample. We use undiluted human plasma or pooled plasma samples. We redesigned our Test Event
assessments to shorten the turnaround times with the inclusion of custom-tailored comments to support troubleshooting and
graphical reports to enhance comparisons within and between peer groups. This program is ISO 17043 accredited and meets
the highest international clinical standards.
4. TORCH AND EBV SEROLOGY

UN
TRCH435
Anti-Toxoplasma IgG Anti-EBV VCA IgG

Anti-CMV IgG Anti-Rubella IgG Anti-HSV-1/2 IgG
Anti-EBV VCA IgM
Anti-CMV IgM Anti-Rubella IgM Anti-Toxoplasma IgM Anti-HSV-1/2 IgM Anti-EBV-EBNA IgG
DESCRIPTION
Application – We designed this as a comprehensive, cost-effective EQA program for laboratories that perform serology testing for
CMV, Rubella, Toxoplasma, HSV and EBV.
Science - Clinicians often request testing for a range of serological analytes to determine cause of illness and facilitate diagnosis
of patients. We created sample sets to mimic the clinical needs, with coverage of all serology analytes relevant to ToRCH and EBV
screening. To improve affordability while maintaining scientific integrity, we offer 5 samples per Test Event. To ensure sufficient sample
volume for testing for multiple analytes and multiple assays, we offer the volume of 1.8 mL per sample. We redesigned our Test
Event assessments to shorten the turnaround times with the inclusion of custom-tailored comments to support troubleshooting
and graphical reports to enhance comparisons within and between peer groups. This program is ISO 17043 accredited and
meets the highest international clinical standards.
10
SEROLOGY EQAS
5. SARS-CoV-2 ANTIBODIES
SAMPLE TYPE: Liquid human plasma
UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SHIPPING CODE: 3373
COVS435
3 Test Events x 5 samples x 0.5 mL
3 shipments No known compatibility issues with any method or analyzer.
COVS432
3 shipments
SARS-CoV-2 IgG* SARS-CoV-2 IgA* SARS-CoV-2 IgM*
DESCRIPTION
Application – We designed this as a comprehensive, cost-effective EQA program for laboratories that perform serology testing for SARS-
CoV-2 antibodies and features single donor human plasma samples with IgG, IgA, and/or IgM antibodies against SARS-CoV-2. This
program has options for 2 and 5 samples per Test Event.
Science - This EQA program has been designed for participants that perform serology testing for SARS-CoV-2 antibodies and features
single donor human plasma samples with IgG, IgA, and/or IgM antibodies against SARS-CoV-2. Single donor samples are traceable to
the donor’s clinical history. These samples are compatible with common serology methods including ELISA, rapid lateral-flow assays,
immunofluorescence, chemiluminescence and electrochemiluminescence. In 2023, this program will be under NRL’s serology offering.
To improve affordability while maintaining scientific integrity, we offer two panel sizes: 5 samples per Test Event and 2 samples per Test
Event. With NRL’s scientific foundation and reformatted Test Event assessments, this program meets the highest international clinical
standards.
*Pending accreditation.
11
MOLECULAR EQAS
The following Test Event Calendar applies for all Programs in the Molecular EQAS section.#
Test Event Test Event Opens Test Event Window Results Deadline
1 8 March 2023 21 days 29 March 2023
2 7 June 2023 21 days 28 June 2023
3 6 September 2023 21 days 27 September 2023
# Note: RESP435, RESV435 and RESB435 follow the Point of Care/Specialised EQAS Test Event Calendar.
12
MOLECULAR EQAS
1. MULTIMARKER BLOOD SCREENING MOLECULAR

UN UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SAMPLE TYPE: Frozen human plasma SHIPPING CODES: 3373 1845
NATA4310
3 Test Events x 10 samples x 4.4 mL Compatible with Blood Screening NAT assays.
1 shipment No known compatibility issues with any method or analyzer.
HBV DNA HCV R N A HIV RNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for blood and tissue screening laboratories that
perform routine molecular testing for HBV DNA, HCV RNA and HIV RNA.
Science - This program is the only ISO 17043 accredited infectious disease blood screening molecular EQAS that offers
samples representative of those normally tested in blood screening molecular testing. To maintain both affordability and scientific
integrity, we offer the panel size of 10 samples per Test Event. To further enhance this program, we calibrate samples to
the prevailing WHO international standards to enable laboratories to assess both the precision and the accuracy of their assays.
We redesigned our Test Event assessments to shorten the turnaround times with the inclusion of custom-tailored comments to
support troubleshooting and graphical reports to enhance comparisons within and between peer groups. This program meets
the highest international quality standards.
2. MULTIMARKER PLASMA FRACTIONATION MOLECULAR

UN UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative and quantitative SAMPLE TYPE: Frozen human plasma SHIPPING CODES: 3373 1845
MMPF4310 3 Test Events x 10 samples x 4.4 mL

1 shipment
No known compatibility issues with any method or analyzer.
HAV RNA Parvovirus B19 DNA HEV RNA CMV DNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for plasma fractionators and laboratories that
perform quantitative and/or qualitative molecular testing for HAV, Parvovirus B19, HEV and CMV.
Science - This program is specially designed for facilities that screen donor samples for plasma fractionation and
comprises samples representative of those normally received for screening. To maintain both affordability and scientific integrity, we
offer the panel size of 10 samples per Test Event. We redesigned our Test Event assessments to shorten the turnaround times with
the inclusion of custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons within and
between peer groups. This program is ISO 17043 accredited and meets the highest international clinical standards.
13
MOLECULAR EQAS
3. VIRAL EXANTHEMS MOLECULAR

UN UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SAMPLE TYPE: Frozen Clinical Liquid Samples SHIPPING CODES: 3373 1845
RASH435
1 shipment
HSV-1 DNA HSV-2 DNA VZV DNA CMV DNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform molecular testing for
HSV-1, HSV-2, VZV and CMV.
Science - Clinicians routinely request screening for HSV, VZV and CMV together. We created syndromic sample sets to meet that clinical
need with coverage of these three analytes. This program allows laboratories using multiplex molecular assays to test EQA samples in the
same manner as testing for patient samples. We redesigned our Test Event assessments to shorten the turnaround times with
the inclusion of custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons within
and between peer groups. This program is ISO 17043 accredited and meets the highest international clinical standards.
4. VIRAL RESPIRATORY MOLECULAR

PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SAMPLE TYPE: Clinical Liquid Samples
RESP435 3 Test Events# x 5 samples x 1.2 mL

3 shipments
Influenza RNA RSV RNA SARS-CoV-2 RNA Influenza A Typing
DESCRIPTION
Application - We designed this comprehensive, cost-effective EQA program for laboratories and Point-of-Care(POC) facilities
that perform molecular testing for Influenza A and B, RSV and SARS-CoV-2.
Science - We created syndromic sample sets for these common respiratory viruses. Samples feature real, inactivated virus (not synthetic
material), which enables monitoring of extraction efficiency as well as detection of analytes. Since the panels of the program can
be shipped at ambient temperature, this program is ideal for both sophisticated laboratories using multiplex molecular assays as well as
POC facilities using platforms such as the Cepheid GeneXpert. We redesigned our Test Event assessments to shorten the
turnaround times with the inclusion of custom-tailored comments to support troubleshooting and graphical reports to enhance
comparisons within and between peer groups. This program is ISO 17043 accredited and meets the highest international clinical
standards.
#Follows Point of Care/Specialised EQAS Test Event Calendar.
14
MOLECULAR EQAS
5. EXTENDED VIRAL RESPIRATORY MOLECULAR
RESV435
3 Test Events# x 5 samples x 0.8 mL
3 shipments
Adenovirus DNA* Rhinovirus RNA* Parainfluenza RNA*

Seasonal Coronavirus RNA*
Enterovirus RNA* Metapneumovirus RNA* Parechovirus RNA*
DESCRIPTION
Application - We are introducing this brand-new comprehensive, cost-effective EQA program in 2023 for laboratories that perform
molecular testing for a wide range of viral respiratory analytes other than Influenza, RSV and SARS-CoV-2.
Science - We created syndromic sample sets for a wide range of viral respiratory analytes other than Influenza, RSV and SARS-
CoV-2, including Human Adenovirus, Enterovirus, Rhinovirus, Metapneumovirus, Parainfluenza, Parechovirus and
Seasonal Coronavirus, which covers majority of the clinical testing requirements for viral respiratory infection. The samples
feature real inactivated virus (not synthetic material) of various strains, which enables monitoring of extraction
efficiency as well as detection of the analytes. The panels of this program can be shipped at ambient temperature. We
redesigned our Test Event assessments to shorten the turnaround times with the inclusion of custom-tailored comments to support
troubleshooting and graphical reports to enhance comparisons within and between peer groups. This program meets the highest
international clinical standards.

6. BACTERIAL PLUS RESPIRATORY MOLECULAR

RESB435
3 Test Events# x 5 samples x 0.8 mL
3 shipments
Bordetella species* Legionella species* Chlamydophila species*

Pneumocystis species*
Streptococcus species* Mycoplasma species* Haemophilus species*
DESCRIPTION
Application - We are introducing this brand-new comprehensive, cost-effective EQA program for laboratories that perform molecular
testing for a wide range of bacterial and fungal respiratory analytes.
Science - We created syndromic sample sets for these common respiratory and pneumonia bacteria and fungi, including Bordetella
species, Streptococcus species, Legionella species, Mycoplasma species, Chlamydophila species, Haemophilus species and
Pneumocystis species. The samples feature real, inactivated bacteria and fungi (not synthetic material) of various strains, which
enables monitoring of extraction efficiency as well as detection of analytes. The panels of this program can be shipped at ambient
temperature. We redesigned our Test Event assessments to shorten the turnaround times with the inclusion of custom-
tailored comments to support troubleshooting and graphical reports to enhance comparisons within and between peer
groups. This program meets the highest international clinical standards.

15
MOLECULAR EQAS
7. SEXUALLY- TRANSMITTED INFECTIONS MOLECULAR

UN UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SAMPLE TYPE: Frozen Clinical Liquid Samples SHIPPING CODES: 3373 1845
STIC435
1 shipment
Trichomonas vaginalis M. genitalium Fluoroquinolone resistant

Chlamydia trachomatis Neisseria gonorrhoeae M. genitalium Macrolide resistant
Ureaplasma species
Chlamydia trachomatis serovar N. gonorrhoeae CFT resistant
Mycoplasma species M. genitalium Azithromycin Resistant
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform molecular testing for
sexually-transmitted infections including Chlamydia trachomatis (including LGV and other serovars), Neisseria gonorrhoeae,
Trichomonas vaginalis, Ureaplasma species, Mycoplasma species and several drug-resistant strains.
Science - We created sample sets to cover a wide range of sexually-transmitted infections including Chlamydia
trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Ureaplasma species and Mycoplasma species. This program also assesses
the laboratories' ability to differentiate between different serovars of Chlamydia trachomatis including LGV, and drug-resistant
strains including Mycoplasma genitalium Fluoroquinolone resistant, Mycoplasma genitalium Macrolide resistant, Mycoplasma
genitalium Azithmycin resistant and Neisseria gonorrhoeae CFT resistant. Laboratories can submit all results for multiple analytes
from multiple assays and/or from multiplex assays. We redesigned our Test Event assessments to shorten the turnaround times
with the inclusion of custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons
8. HIV MOLECULAR
UN UN
HIVL435 3 Test Events x 5 samples x 1.4 mL

1 shipment
HIV RNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform HIV RNA viral load
testing and HIV RNA detection.
Science - We calibrated sample sets to the prevailing WHO international standard to enable laboratories to assess the
accuracy of their testing, the Limits of Detection (LOD), the reproducibility and repeatability of their assays, and the coefficient of
variation within their laboratories and peer group. We believe this is the only ISO 17043 accredited EQA program of its type globally
that uses samples derived from a secondary WHO international standard. In 2023, we are increasing the volume per
sample to 1.4 mL, to accommodate the needs of testing on multiple assays, retesting and troubleshooting. We
troubleshooting and graphical reports to enhance comparisons within and between peer groups. This program is ISO 17043
accredited and meets the highest international clinical standards.
16
MOLECULAR EQAS
9. HBV MOLECULAR
UN UN
HBVL435
1 shipment
HBV DNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform HBV DNA viral load
testing and HBV DNA detection.
Science - We calibrated sample sets to the prevailing WHO international standard to enable laboratories to assess
the accuracy of their testing, the Limits of Detection (LOD), the reproducibility and repeatability of their assays, and the
coefficient of variation within their laboratories and peer group. We believe this is the only ISO 17043 accredited EQA program of its
type globally that uses sample sets derived from a secondary WHO international standard. In 2023, we are increasing
the volume per sample to 1.4 mL, to accommodate the needs of testing on multiple assays, retesting and
troubleshooting. We redesigned our Test Event assessments to shorten the turnaround times with the inclusion of
custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons within and
between peer groups. This program is ISO 17043 accredited and meets the highest international clinical standards.
10. HCV MOLECULAR

UN UN
HCVQ435 3 Test Events x 5 samples x 1.4 mL

1 shipment
HCV RNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform HCV RNA viral load
testing and HCV RNA detection.
Science - We calibrated sample sets to the prevailing WHO international standard to enable laboratories to assess the
accuracy of their testing, the Limits of Detection (LOD), the reproducibility and repeatability of their assays, and the coefficient of
variation within their laboratories and peer group. We believe this is the only ISO 17043 accredited EQA program of its type globally that
uses sample sets derived from a secondary WHO international standard. In 2023, we are increasing the volume per sample to
1.4 mL, to accommodate the needs of testing on multiple assays, retesting and troubleshooting. We redesigned our Test
Event assessments to shorten the turnaround times with the inclusion of custom-tailored comments to support troubleshooting
and graphical reports to enhance comparisons within and between peer groups. This program is ISO 17043 accredited and
meets the highest international clinical standards.
17
MOLECULAR EQAS
11. HPV MOLECULAR

UN UN
PROGRAM TYPE: Comprehensive ANALYSIS: Qualitative SAMPLE TYPE: Frozen Liquid Based Cytology Medium SHIPPING CODES: 3373 1845
HPVN435
3 Test Events x 5 samples x 1.2 mL No known compatibility issues with any method or analyzer.
1 shipment
HPV High Risk 16 DNA HPV High Risk 18 DNA Other High Risk HPV DNA
DESCRIPTION
Application - We designed this as a comprehensive, cost-effective EQA program for laboratories that perform molecular testing for high-
risk HPV detection and genotyping.
Science - We created sample sets derived from real patient specimens. Samples consist of known HPV genotypes, including HPV high-risk
types 16 and 18, and now are being extended to include more other high-risk HPV genotypes. Samples are provided in liquid-
based cytology fluid suitable for all test systems. Laboratories can submit all results from multiple assays including HPV
detection and genotypes. We redesigned our Test Event assessments to shorten the turnaround times with the inclusion of custom-
tailored comments to support troubleshooting and graphical reports to enhance comparisons within and between peer groups.
This program is ISO 17043 accredited and meets the highest international clinical standards.
12. CMV MOLECULAR

UN UN
CMVN435
1 shipment
CMV DNA
DESCRIPTION
Application - We are re-introducing CMVN as a comprehensive, cost-effective EQA program for laboratories that perform quantitative
and/or qualitative molecular testing for CMV in plasma sample type.
Science - CMVN program was discontinued in 2020 and we are re-introducing this program for 2023 to accommodate the requirement
of laboratories that perform quantitative and/or qualitative molecular testing for CMV in plasma sample type. To maintain
both affordability and scientific integrity, we offer the panel size of 5 samples per Test Event. We redesigned our Test
Event assessments to shorten the turnaround times with the inclusion of custom-tailored comments to support
18
POINT OF CARE AND SPECIALISED EQAS
The following Test Event Calendar applies to all Programs in the Point-of-Care/Specialised EQAS and
RESP435, RESV435 and RESB435 EQAS.
Test Event Test Event Open Test Event Window Results Deadline
1 29 March 2023 23 days 21 April 2023
2 28 June 2023 21 days 19 July 2023
3 27 September 2023 21 days 18 October 2023
19
1. C. TRACHOMATIS, N. GONORRHOEAE & T. VAGINALIS MOLECULAR POC

PROGRAM TYPE: Point-of-Care ANALYSIS: Qualitative SAMPLE TYPE: Clinical Swabs
CNTP435
3 Test Events x 5 samples
3 shipments
CNTP432
3 shipments
Chlamydia trachomatis Neisseria gonorrhoeae Trichomonas vaginalis
DESCRIPTION
Application - We designed this as a simplified, cost-effective EQA program for Point-of-Care (POC) facilities and laboratories in
resource limited settings that perform molecular testing on Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis
using POC platforms such the Cepheid GeneXpert. This program has options for 2 and 5 samples per Test Event.
Science - We optimised sample sets for POC testing platforms such as the Cepheid GeneXpert. Samples are dried swabs, and feature
inactivated organisms, which means that the panels of this program are stable, non-infectious (UN3373 exempt) and shipped at
ambient temperature. We redesigned our Test Event assessments to shorten the turnaround times with the inclusion of custom-tailored
comments to support troubleshooting and graphical reports to enhance comparisons within and between peer groups. This program is
ISO 17043 accredited and meets the highest international clinical standards.
2. DRIED TUBE SAMPLE HIV AND EARLY INFANT DIAGNOSIS MOLECULAR POC
PROGRAM TYPE: Point-of-Care ANALYSIS: Qualitative and Quantitative SAMPLE TYPE: Dried human plasma matrix
DTSI435
3 shipments Not compatible with the Cavidi ExaVir Load Version 3.0 kit.
Compatible with proviral DNA assays for testing Early Infant
DTSI432
3 Test Events x 2 samples Diagnosis.
3 shipments
HIV RNA Proviral HIV DNA
DESCRIPTION
Application - We designed this as a simplified, cost-effective EQA program for Point-of-Care (POC) facilities and laboratories in resource
limited settings that perform molecular testing for HIV Viral Load, HIV RNA detection and also early infant diagnosis (EID) testing for HIV
proviral DNA, particularly those engaged in HIV elimination initiatives. This program has options for 2 and 5 samples per Test Event.
Science - After extensive research, development and validation, we created dried tube samples (DTS) suitable for HIV RNA viral load,
HIV RNA detection and also early infant diagnosis (EID) testing for HIV proviral DNA. This is the only international ISO 17043 accredited
DTS EQAS for HIV molecular testing. This program features inactivated dried human plasma samples, optimised for both POC platforms
such as the Cepheid GeneXpert and laboratory platforms. The panels of this program are stable, non-infectious (UN3373 exempt) and
shipped at ambient temperature. We redesigned our Test Event assessments to shorten the turnaround times with the inclusion of
custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons within and between peer
groups. This program is ISO 17043 accredited and meets the highest international clinical standards.
20
3. DRIED TUBE SAMPLE HBV MOLECULAR POC

DTSB435
3 shipments
No known compatibility issues.
DTSB432 3 Test Events x 2 samples

3 shipments
HBV DNA
DESCRIPTION
limited settings that perform molecular testing for HBV DNA Viral Load and HBV DNA detection. This program has options for 2 and 5
samples per Test Event.
Science - After extensive research, development and validation, we created dried tube samples (DTS) suitable for HBV DNA viral load
and HBV DNA detection. This is the only international ISO 17043 accredited DTS EQAS for HBV molecular testing. This program features
inactivated dried human plasma samples, optimised for both POC platforms such as the Cepheid GeneXpert and laboratory
platforms. The panels of this program are stable, non-infectious (UN3373 exempt) and shipped at ambient temperature. We
4. DRIED TUBE SAMPLE HCV MOLECULAR POC

DTSC435
3 shipments
No known compatibility issues.
DTSC432
3 shipments
HCV RNA
DESCRIPTION
limited settings that perform molecular testing for HCV RNA Viral Load and HCV RNA detection. This program has options for 2 and 5
samples per Test Event.
Science - After extensive research, development and validation, we created dried tube samples (DTS) suitable for HCV RNA viral load
and HCV RNA detection. This is the only international ISO 17043 accredited DTS EQAS for HCV molecular testing. This program features
inactivated dried human plasma samples, optimised for both POC platforms such as the Cepheid GeneXpert and laboratory
platforms. The panels of this program are stable, non-infectious (UN3373 exempt) and shipped at ambient temperature. We
21
5. HTLV MOLECULAR
UN
PROGRAM TYPE: Specialised ANALYSIS: Quantitative and Qualitative SAMPLE TYPE: Human whole blood matrix SHIPPING CODE: 3373
HTLD435
3 shipments
Proviral HTLV DNA
DESCRIPTION
Application - This program offers a unique EQA for the molecular testing for detection of proviral HTLV DNA. The program assesses
linearity, reproducibility and limit of detection of the assay in use.
Science - We designed the human T-cell lymphotropic virus (HTLV) Molecular EQA program consisting of 5 samples to be sent out three
times a year. Samples consist of SP cells diluted with stabilised red cells, creating a matrix designed to mimic whole blood. SP cells are
human T cells containing a single full-length copy of HTLV-1 DNA. The program assesses linearity, reproducibility and limit of detection of
the assay in use.
6. LEPTOSPIROSIS MOLECULAR
PROGRAM TYPE: Specialised ANALYSIS: Qualitative SAMPLE TYPE: Clinical Liquid Samples
LEPN435
3 shipments
Leptospira species
DESCRIPTION
Application - We designed this as a simplified, cost-effective EQA program for laboratories that perform testing for leptospirosis
detection and genotyping.
Science - We collaborated with the International Leptospirosis Society to create inactivated sample sets that include
a range of Leptospira species to assess the laboratories ability to detect and distinguish between species. The panels of this program
are stable, non-infectious (UN3373 exempt) and are shipped at ambient temperature. We redesigned our Test Event assessments to
shorten the turnaround times with the inclusion of custom-tailored comments to support troubleshooting and graphical reports to
enhance comparisons within and between peer groups. This program is ISO 17043 accredited and meets the highest international
clinical standards.
22
7. MYCOBACTERIUM MOLECULAR POC

PROGRAM TYPE: Point-of-Care/Specialised ANALYSIS: Qualitative SAMPLE TYPE: Clinical Liquid Samples
MTBN435
3 shipments
MTBN432 3 Test Events x 2 samples x 1.2 mL

3 shipments
Mycobacterium species Drug Resistance Typing
DESCRIPTION
Application - We designed this as a simplified, cost-effective EQA program for laboratories performing molecular testing for
Mycobacterium tuberculosis and/or its drug resistance typing (Rifampicin resistance and now extended to other resistance types), and
particularly optimised for resource limited settings and Point-of-Care (POC) testing sites. This program has options for 2 and 5 samples
per Test Event.
Science - We created inactivated bacterial samples that include wild type and drug resistant strains (Rifampicin resistance and
now extended to other resistance types) of Mycobacterium tuberculosis. The panels of this program are stable, non-infectious
(UN3373 exempt) and shipped at ambient temperature. We redesigned our Test Event assessments to shorten the turnaround
times with the inclusion of custom-tailored comments to support troubleshooting and graphical reports to enhance comparisons
23
www.nrlquality.org.au
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T: +61 3 9418 1124

2023 NRL EQAS Catalogue

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2023 NRL EQAS Catalogue

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2023 NRL External Quality Assessment Schemes

The First Principle 6

Why Results Deadlines Matter 7

o Multimarker Blood Screening Serology 9

o Multimarker Blood Screening Molecular 13

Point-of-Care and Specialised EQAS 19

o C. trachomatis, N. gonorrhoeae & T. vaginalis Molecular POC 20

NRL, as a World Health Organization (WHO)

NRL is certified to ISO 9001, Quality Management

• Designed for sophisticated laboratory-based testing as well as testing in low/middle-income

Point-of-Care (POC) EQAS:

In partnership with Oneworld Accuracy (www.oneworldaccuracy.com) and its extensive network

• CMV Molecular Program (CMVN435) is being re-introduced in 2023:

• Sexually-Transmitted Infections Molecular Program (STIC435)now includes:

v HPV Molecular Program (HPVN435) now:

• Mycobacterium Molecular POC Program (MTBN435) now:

• SARS-CoV-2 Antigen Program (COVA434) is being discontinued in 2023.

For any additional queries, we are here to answer your questions:

T: +61 3 9418 1124

The Test Event Cycle

Test Event Reminder

Test Samples Instructions + Worksheets

Results Deadline Reminders

Receive Performance Reports

Here's how we acknowledge your commitment to testing quality

exactly as you would patient samples.

relevant and timely results.

patient samples and report results. This means you must:

Around-Time measured in days before the Results Deadline.

Our Program Codes give you Program Details

HEPM435 Number of samples

Number of Test Events

2023 Test Event Calendar

1 29 March 2023 23 days 21 April 2023

2 28 June 2023 21 days 19 July 2023

3 27 September 2023 21 days 18 October 2023

1. MULTIMARKER BLOOD SCREENING SEROLOGY

PROGRAM CODE FORMAT COMPATIBILITY

HIV p24 Ag HCVAg HBsAg Anti-HTLV

PROGRAM CODE FORMAT COMPATIBILITY

Anti-HAV IgG HBsAg Anti-HBs HCVAg

3. RETROVIRUS AND SYPHILIS SEROLOGY

PROGRAM CODE FORMAT COMPATIBILITY

HIV p24 Ag Anti-Treponema pallidum Anti-HTLV

4. TORCH AND EBV SEROLOGY

PROGRAM CODE FORMAT COMPATIBILITY

Anti-Toxoplasma IgG Anti-EBV VCA IgG

PROGRAM CODE FORMAT COMPATIBILITY

SARS-CoV-2 IgG* SARS-CoV-2 IgA* SARS-CoV-2 IgM*

2023 Test Event Calendar

1 8 March 2023 21 days 29 March 2023

2 7 June 2023 21 days 28 June 2023

3 6 September 2023 21 days 27 September 2023

1. MULTIMARKER BLOOD SCREENING MOLECULAR

PROGRAM CODE FORMAT COMPATIBILITY

HBV DNA HCV R N A HIV RNA

2. MULTIMARKER PLASMA FRACTIONATION MOLECULAR

PROGRAM CODE FORMAT COMPATIBILITY

MMPF4310 3 Test Events x 10 samples x 4.4 mL