Knowledge Base

A

A 16-year review of seroprevalence studies on measles and rubella. Vaccine

This study explores the determination of the seroprevalence of vaccine-preventable diseases such as measles and rubella, demonstrating how it is critical in monitoring the efficacy of vaccination programmes and to assess the gaps in population.

A Proposed Approach to Estimating Uncertainty of Measurement in Serological Assays

Publications

This publication investigates the methods of estimating MU for serological assays, considering sources of variation relating to serology results, and including pre- and post-analytical variation, biological variation and variation introduced during the assay process.

A Protocol for Validating Assembled Nucleic Acid Tests

Procedures Publications

This publication describes and provides procedures for the validation of assembled NAT for medical microbiology and virology laboratories.

A review of testing used in seroprevalence studies on measles and rubella Vaccine

Publications

This publication conducts an overarching review of all aspects of seroprevalence studies for measles and rubella published between 1998 and June 2014, with the findings reported elsewhere.

Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia

Publications

This publication analysed the testing results from ACCESS Laboratory Network in order to showcase the data trends of Chlamydia among Australians from 2008-2010.

ASHM Testing Portal

Policies

These polices are for health professionals ordering HIV, hepatitis C and hepatitis B tests and receiving, interpreting and delivering results to patients, setting out a framework for providing quality testing and removing real and perceived barriers to testing.

Assessing Serology Quantitative Values in Infectious Diseases EQAS

Posters NRL Workshop

Serological testing on the ADVIA Centaur system for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in specimens from deceased and living individuals demonstrates equivalent results

Publications

Wright T1, Patibandla S1, Walsh R1, Fonstad R1, Gee M1, Bitcon V1, Brendle J1, Hopper J2, Degenu P2, Braniff S3, Best S3, Read S4.

B

Best Practice Laboratory Testing for Transfusion Transmissible Infections

Publications

This publication supports and improves technical skills of all those who work in the field of transfusion medicine. It showcases the latest developments for the management of transfusion medicine departments and laboratories, as well as assuring quality, reliability, and safety in their workplaces.

Bleeding Love: NRL’s Plasma Biobank

Posters

C

Calculating Uncertainty of Measurement for Serology Assays by Use of Precision and Bias

Publications

This publication explores the estimate of uncertainty of measurement (MU) of assay test results, by analysing imprecision and bias in peer-group run control data.

Challenging QC Paradigm for Infectious Diseases

Education Presentations

In this lecture, Wayne Dimech discusses the traditional approach to monitoring the quality control of infectious disease testing and considers an alternate approach these processes. Please note, a free subscription is required for viewing this lecture. You can subscribe via the link above.

Characterization of Hepatitis B Precore/Core-Related Antigens

Publications

This publication provides new quantitative information on the levels of each component of precore/core gene products, as well as their biochemical and biophysical characteristics.

Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing

Publications

This publication explores the systematic assessment of methods used to establish QC limits in infectious disease serology testing.

Comprehensive Quality Control Programme for Serology and Nucleic Acid Testing using an Internet based Application

Publications

This publication explores NRLs system EDCNet, demonstrating how it allows laboratories to monitor both precision and accuracy of results by comparing results of other laboratories, making it a highly cost-effective method for maintaining quality.

Cost-benefit analysis of two quality control approaches for infectious disease testing

QC Publications QConnect

Counterpoint to the Letter to the Editor by Badrick and Parvin in regard to Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing

Publications

This Publication is a counterpoint to the letter to the editor which explores the discussion regarding the application of statistical process control to infection disease serology.

Covid-19 Testing: Maintaining Quality in a State of Emergency

Publications

Catalogue

Accreditation

D

Determination of quality control limits for serological infectious disease testing using historical data.

Publications

This publication demonstrates how the NRL QC program provides users with evidence-based control limits that can be applied in isolation or in conjunction with more traditional methods as an effective quality control (QC) program.

Does a Change in Quality Control Results Influence the Sensitivity of an anti-HCV Test?

Publications

This publication explored how unexpected changes in QC reactivity related to variation, in particular assay lot changes, may affect patient results.

E

EDCNet Troubleshooting Flow Chart

TroubleShooting QC QConnect

Editing QC Results

QConnect

Entering QC Results

QConnect

EQAS Catalogue 2025

EQAS

EQAS Order Form

EQAS

EQAS Standard Terms & Conditions

Requirements

Evaluation of Eight Anti-rubella Virus Immunoglobulin G Immunoassays that Report Results in International Units per Milliliter

Publications

This publication performed an evaluation of anti-rubella virus immunoglobulin G (IgG) immunoassays that report in international units per milliliter (IU/ml), to determine their analytical performance and the degree of correlation of the test results.

Evaluation of Three Immunoassays used for the Detection of Anti-Rubella Virus Immunglobulin M Antibodies

Publications

This publication evaluated three automated assays (Abbott AxSYM, Bayer ADVIA Centaur, and bioMerieux VIDAS), exploring their analytical and clinical sensitivities and specificities used to detect RV IgM.

Evidence-based assessment of the application of Six Sigma to infectious disease serology quality control

QC Publications QConnect

This paper compares and critically reviews the methods used to calculate the Sigma value for each assay in the four studies and provides an evidence-based assessment of these approaches using real-world quality control data obtained from the National Serology Reference Laboratory, Australia (NRL) QConnect™ quality control program.

Why NRL EQAS?

EQAS

F

Final WHO SARS-CoV-2 serology test kit evaluation results

Reports

This report evaluated the performance of test kits in different formats, to detect antibodies to SARS-CoV-2, and assess the performance data from a range of commercially available IVDs.

First Line Checklist

Guidelines TroubleShooting QC QConnect

G

Guidelines for Approved Pathology Collection Centres (Requirements for medical pathology specimen collection) (Third Edition 2013)

Guidelines

These guidelines are a Tier 3B NPAAC document, which outlines the minimum requirements for best practice for all Specimen collection.

Guidelines on the use of Serosurveys in Support of Measles and Rubella Elimination

Guidelines

This serosurvey developed by WHO demonstrates a collaborative effort between epidemiologists and laboratory scientists, to provide accurate and reliable results on measles and rubella elimination.

H

High Rates of Undiagnosed HIV Infections in a Community Sample of Gay Men in Melbourne, Australia

Publications

This publication calculated HIV and undiagnosed HIV prevalence and used x2 tests and logistic regression to examine associations between participant characteristics and HIV status.

HIV point-of-care tests: Conditions of approval for supply in Australia

Guidelines

These guidelines outline the conditions of approval for supply in Australia, applying specifically to HIV point-of-care tests (PoCT), which are screening tests intended to be used by trained healthcare professionals in clinical settings, near the patient.

I

Identifying the critical cut-points of a quality control process for serological assays: results from parametric and semiparametric regression models Accreditation and Quality Assurance

Publications

This publication creates and explores a proposed statistical analysis framework which combines novel statistical analysis and visualization techniques to determine the functional relationship between the quality control and blood donor’s negative results.

Implementation of Novel Quality Assurance Program for Hepatitis C Viral Load Point of Care Testing

Publications

This publication assessed the provision of laboratory-based quality assurance to PoCT for infectious disease, and the barriers to participation were identified.

Improving the coverage and accuracy of syphilis testing: The development of a novel rapid, point-of-care test for confirmatory testing of active syphilis infection and its early evaluation in China and South Africa

Publications

This publication reports the development and early evaluation of a new prototype POCT based on the detection of TP-IgA antibodies, a novel biomarker for active syphilis.

In-vitro diagnostic (IVD) medical devices regulations

Guidelines

These guidelines provide links to information on in vitro diagnostic (IVD) medical devices, including HIV and nutrigenetic tests.

Increased testing for Neisseria gonorrhoeae with duplex nucleic acid amplification tests in Australia: implications for surveillance

Publications

This publication explores how Gonorrhoea notifications have been increasing in Australia's cities, in both men and women, and investigated if this could be, at least in part, a result of a testing artefact.

Increasing access by priority populations to Australian sexual health clinics

Publications

This publication collected data from a network of 35 Australian sexual health clinics in geographically diverse locations, demonstrating that the number and proportion of patients from priority populations increased significantly between 2004 and 2011.

Introduction to NRL

Presentations

Investigation into Low-Level Anti-Rubella Virus IgG Results Reported by Commercial Immunoassays

Publications

This publication analysed a total of 500 quantitative results obtained from 100 samples from each CIA were compared with results obtained from an in-house enzyme immunoassay (IH-EIA) calibrated using the WHO standard. All 500 samples were screened using a hemagglutination inhibition assay (HAI).

Investigation of the performance of serological assays used for Lyme disease testing in Australia

Publications

This publication determines the level of agreement in results between commonly used B. burgdorferi serology assays in specimens of known status, and between results reported by different laboratories when they use the same serology assay.

Isotype-switched immunoglobulin G antibodies to HIV Gag proteins may provide alternative or additional immune responses to ‘protective’ human leukocyte antigen-B alleles in HIV controllers

Publications

This publication analyses plasma from 32 HIV controllers and 21 noncontrollers for immunoglobulin G1 (IgG1) and IgG2 antibodies to HIV proteins in virus lysates by western blot assay and to recombinant (r) p55 and gp140 by ELISA. Natural killer (NK)bcell-activating antibodies and FcgRIIa-binding immune complexes were also assessed.

K

Key Facts in Covid-19 Testing

Publications

L

Low Genetic Diversity of Hepatitis B Virus Surface Gene amongst Australian Blood Donors

Publications

The publication demonstrates that HBV small surface gene sequences from Australian donors demonstrated a lower level of genetic diversity than those from non-Australian donor population.

M

Manual for the Laboratory-based Surveillance of Measles, Rubella, and Congenital Rubella Syndrome

Guidelines Publications

This publication explores how immunization programmes, specifically the Rubella-containing vaccine, has caused the successful elimination of endemic rubella transmission in the western hemisphere and several European countries.

Monitoring the Control of Sexually Transmissible Infections and Blood-Borne Viruses: Protocol for the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance

Publications

This publication establishes and explores a national surveillance network designed to monitor public health outcomes and evaluate the impact of strategies aimed at controlling BBVs and STIs.

MU Order Form

QConnect

N

National Pathology Accreditation Advisory Council (NPAAC) Guidelines

Guidelines

This guideline describes the pathology accreditation standards used in Australia protect the public from harm and ensure consistency in pathology practice.

NRL Workshop - Adelaide and Beyond

NRL Workshop

NRL Workshop - Sightseeing Tours and Charters

NRL Workshop

NRL Workshop- Pre & Post Touring Information

NRL Workshop

O

Overlays

QConnect

P

Pathology laboratory surveillance in the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance of sexually transmitted infections and blood borne viruses: Study Protocol

Study

This study explores ACCESS, the pathology laboratory sentinel surveillance network, and demonstrates how It complements the ACCESS clinical network and enhances Australia’s capacity to respond to STIs and BBVs.

Policy analysis: User monitoring of in-vitro diagnostic medical devices used for near-patient testing of infectious diseases.

Publications

This publication reviews the application of QA of PoCT used to detect infectious diseases, and propose fit-for-purpose alternatives.

Post Market Monitoring of In-vitro Diagnostic Devices for Infectious Disease Near Patient Testing using Quality Assurance

Publications

This publication seeks to define quality assurance processes that are suitable for use in non-laboratory, point of care settings and contribute data for real-time post market surveillance of IVDs.

Poster Post-market Evaluation of COVID-19 RATs for the TGA

NRL Workshop

Privacy Policy

Policies Procedures

This document describes NRL’s privacy policy and principles.

Proficiency Testing and Ring Trials

Publications

This publication explores how the validation of diagnostic methods are improved through participation in inter-laboratory comparisons (IC), such as proficiency-testing (PT) programmes and ‘ring trials’.

Q

QC Report Function Overview

QConnect

QC Reports LJ charts and Trending

QConnect

QC Reports Mean Scatter Function Overview

QConnect

QC Serology Investigation PMM-QC-1480

Reference Materials QConnect

QC Serology Investigation PMM-QC-689

Reference Materials QConnect

QC Serology Investigation PMM-QC-706

Reference Materials QConnect

QC Serology Investigation PMM-QC-713

Reference Materials QConnect

QC Serology Investigation PMM-QC-794

Reference Materials QConnect

QC Serology Investigation PMM-QC-860

Reference Materials QConnect

QC Serology Investigation PMM-QC-885

Reference Materials QConnect

QC Serology Investigation PMM-QC-981

Reference Materials QConnect

QC Serology Investigation PMM-QC-982

Reference Materials QConnect

QC Services Investigation: PMM-QC-1583

QC Reference Materials QConnect

NRL was contacted by EDCNet participants regarding negative S/Co values observed for Optitrol HIVp24 lot DM22200 when testing with the DiaSorin LIAISON XL MUREX HIV Ab/Ag Assay, on reagent lot 139054. NRL investigated all data reported by the peer group. All Optitrol HIVp24 and reagent lots in use were reviewed for the DiaSorin LIAISON XL MUREX HIV assay along with data for all other assays where Optitrol HIVp24 is recommended for use, to establish if the negative S/Co values were observed for any other participant, Optitrol HIVp24 or reagent lot.

QC Services Investigation: PMM-QC-1593

QC Reference Materials QConnect

This investigation reviewed data reported to EDCNet for Optitrol Blue lots DM22009 and DM22121 reported for the Abbott Alinity s Anti-HTLV I/II assay and the Abbott Alinity i, Abbott Architect and DiaSorin Liaison platforms to establish if this variation was observed across any other platform.

QC Services Investigation: PMM-QC-1661

QC Reference Materials QConnect

QC Services Investigation: PMM-QC-1784

QC Reference Materials QConnect

PMM-QC-1878

QC Reference Materials QConnect

NRL observed a shift up in S/Co values for Optitrol HEPR-2 DM24038 when tested with the Abbott Alinity i HAV Ab IgG assay. NRL investigated the performance of Optitrol HEPR-2 DM24038 and other related production lots, DM23002 and DM23080, as well as the performance of Optitrol HEPR-2 DM24038 when used with the Abbott and other assays and platforms the EQC had been designed for establish if this variation was observed across any other platforms and or Optitrol lots for root cause investigation.

QC Services Investigation: PMM-QC-2025

QC Reference Materials Publications QConnect

An investigation regarding a shift up in data observed for Optitrol Blue lot DM23117 when testing with the Abbott Alinity i rHTLV-I/II assay for reagent lot 60107BE00. The investigation looked at all peer group data reported for this assay and related production lots of Optitrol Blue, in addition other Alinity i assay and both the Alinity s and ARCHITECT HTLV assays where Optitrol Blue were reported were also reviewed to establish whether reagent lot variation was the source of the variation observed.

QC Services Investigation: PMM-QC-2434

QC Reference Materials Publications QConnect

NRL was contacted by an Optitrol QConnect Distributor regarding an observed progressive decrease in S/Co value when testing Optitrol Blue DM23117 on the Abbott Alinity i HBsAg Qualitative II assay and Abbott ARCHITECT HBsAg Qualitative II assay. All data available reported to EDCNet for HBsAg assays testing with Optitrol Blue DM23117 were reviewed.

QConnect Instructions For Use

QConnect

QConnect Introduction

QConnect

QConnect NAT Australia order form

QConnect

QConnect NAT New Zealand order form

QConnect

QConnect QC Controls Catalogue

QConnect

QConnect Safety Data Sheets (SDS) and Certificates of Analysis (CofA)

QConnect

QConnect Serology Australia order form

QConnect

QConnect Serology New Zealand order form

QConnect

Quality management of point-of-care testing devices: In A Practical Guide to Global Point-of-Care Testing

Publications

This publication defines what Point-of-care testing (POCT) is, and explores the benefits and clinical outcomes for settings including family practices, Indigenous medical services, community health facilities, rural and remote areas and in developing countries.

Quality Management System Certificate - ISO9001:2015

Accreditation

R

Real-world monitoring progress towards the elimination of hepatitis C virus in Australia using sentinel surveillance of primary care clinics; an ecological study of hepatitis C virus antibody tests from 2009 to 2019

Publications

This publication assesses the trends in testing and evaluates the effectiveness of strategies to diagnose people living with HCV.

Real-world trends in incidence of bacterial sexually transmissible infections among gay and bisexual men using HIV pre-exposure prophylaxis (PrEP) in Australia following nationwide PrEP implementation: an analysis of sentinel surveillance data.

Publications

The publication aimed to describe trends in bacterial STI incidence among gay and bisexual men using PrEP across Australia in the context of broad PrEP availability through Australia's subsidised medicines scheme.

Requirements for laboratory testing for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) (Third Edition 2013)

Requirements Standards

This requirement is a Tier 4 NPAAC document, which outlines and sets the minimum standards for good pathology practice in Australia for testing for HIV and HCV

Requirements for medical pathology services (Third Edition 2018)

Requirements Standards

This document outlines the standards for good medical pathology practice, where the primary consideration is patient welfare, and where the needs and expectations of patients, Medical Pathology Service staff and referrers are safely and satisfactorily met in a timely manner.

Requirements for medical testing of microbial nucleic acids (Second Edition 2013)

Requirements Standards

These requirements are a Tier 4 NPAAC document, which applies to tests used for the detection, characterisation and quantification of nucleic acids (deoxyribonucleic acid or DNA and ribonucleic acid or RNA) in medical Laboratories testing for microorganisms that can or may cause disease in humans.

Requirements for point of care testing (Second Edition 2021)

Requirements Standards

These Requirements set out the minimum requirements for governance, management systems, staff training, safety, environmental issues, and specimen and result integrity related to the performance of point of care testing (PoCT).

Requirements for quality control, external quality assurance and method evaluation (Sixth Edition 2018)

Requirements Standards

This is a is a Tier 3B NPAAC document, which outlines the general features that an IQC system and an EQA program must have to provide an effective monitoring strategy for the various pathology disciplines.

Requirements for supervision in the clinical governance of medical pathology laboratories (Sixth Edition 2021)

Requirements Standards

This document describes the role and responsibilities of the Designated Person described in the Tier 2 document Requirements for Medical Pathology Services.

Requirements for the communication of high risk pathology results (First Edition 2020)

Requirements Standards

This document is a Tier 3A NPAAC document, used to provide guidance and the minimum best practice standards for the management and communication of high risk pathology results by the pathology service.

Requirements for the development and use of in-house in vitro diagnostic medical devices (IVDs) (Fourth Edition 2018)

Requirements Standards

This requirement is a Tier 3B NPAAC document, which outlines the principles and assessment criteria by which in-house IVDs must be designed, developed, produced, validated and monitored for use by medical laboratories in Australia.

Requirements for the estimation of measurement of uncertainty (2007 Edition)

Requirements Standards

This document, a NPAAC standard and accompanying guidelines, provide general guidance for the practical implementation of MU in medical laboratories, taking account of the limitations of biological measurement and the basic principles of MU.

Requirements for the packaging and transport of pathology specimens and associated materials (Fourth Edition 2013)

Requirements Standards

This is a Tier 3B NPAAC document, which provides the requirements for the packaging and transportation of biological Specimens from the point of first collection to the Laboratory site where analytical testing is carried out.

Requirements for the retention of laboratory records and diagnostic material

Requirements Standards

The Requirements for the retention of laboratory records and diagnostic material is a tier 3B NPAAC, and represents the minimum standards for retention of laboratory records and materials.

Results of Cytomegalovirus DNA Viral Loads Expressed in Copies per Millilitre and International Units per Millilitre are Equivalent

Publications

This publication explores the international standard for CMV DNA, forming the benchmark to determine the rate of future adoption if reporting CMV DNA viral load results in IU/mL.

S

Setting EQC Limits

QConnect

Simian Immunodeficiency Virus Infects Follicular Helper CD4 T Cells in Lymphoid Tissues during Pathogenic Infection of Pigtail Macaques

Publications

This publication studied lymph nodes and spleens from pigtail macaques infected with pathogenic strain SIVmac239 or SIVmac251, to investigate the susceptibility of Tfh cells to SIV infection.

Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies

Publications

This publication explores the analytical and clinical consequences to the lack of standardization of rubella virus IgG assays, leading to misinterpretation of results.

Standardization of Assays That Detect Anti-Rubella Virus IgG Antibodies

Publications

This publication describes the virology of rubella virus infection and examines the history of testing for rubella virus IgG, exploring how the current approach to standardization of rubella virus IgG assays has not achieved the desired results.

Standardization of Diagnostic Assays In Encyclopaedia of Virology

Publications

This publication explores how the standardization of diagnostic assays are essential for the accurate and reliable diagnosis of viral infections, and how it has been applied to nucleic acid testing as well as serological methods.

Strengthening Laboratory Testing - A Call for Quality, Innovation, and Systemic Change

Education Publications

Laboratory testing plays a pivotal role in modern healthcare, forming the backbone of clinical decision-making across the globe. With approximately 70% of clinical decisions relying on laboratory data, the importance of accuracy, timeliness, and reliability in diagnostic testing cannot be overstated. The COVID-19 pandemic exposed weaknesses in laboratory systems worldwide, underscoring the urgent need to strengthen diagnostic capacity, not only to respond to emergencies but also to support routine care.

Supplementary Information for all NRL EQAS Final Reports

EQAS Publications

T

The Complexity of Infectious Disease Testing

Education Presentations

In this lecture, Wayne Dimech of the NRL Australia will present on the complexity of infectious disease testing from its history to how assay design can influence results. Please note, a free subscription is required for viewing this lecture. You can subscribe via the link above.

The Difference in Self-Reported and Biological Measured HIV Prevalence: Implications for HIV Prevention

Publications

This publication measured biological HIV prevalence among gay men in Melbourne, Australia, using a facility-based sampling method, and calculated HIV prevalence and used logistic regression to assess correlates of a positive HIV test.

The Incidence of Hepatitis C Among Gay, Bisexual, and Other Men Who Have Sex With Men in Australia, 2009–2019

Publications

The publication reviews the HCV incidence among GBM living with HIV in Australia from 2009-2019, using data drawn from the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance.

The new screening program to prevent cervical cancer using HPV DNA: getting the balance right in maintaining quality

Publications

The publication explores the new screening strategy that Australia is adopting, which involves moving from cervical cytological screening to molecular nucleic acid technology (NAT), using HPV DNA assays as primary screening methodology for cervical cancer prevention.

The Standardization and Control of Serology and Nucleic Acid Testing for Infectious Diseases

Publications

This publication investigates the reasons why standardization and control of infectious diseases should be further investigated, and more appropriate guidelines should be implemented.

Time to address quality control processes applied to antibody testing for infectious diseases Clinical Chemistry and Laboratory Medicine

Publications

This publication explores the differences between infectious disease serology and clinical chemistry testing, highlighting how these differences have not been considered when applying traditional quality control methods to serology, making the use of quality control methods used in clinical chemistry inappropriate.

Tracking the uptake of outcomes of hepatitis B virus testing using laboratory data in Victoria, 2011-16: a population-level cohort study

Publications

The publication findings indicate an increased uptake of guideline-based hepatitis B testing, showing that the ongoing collection of testing data can help monitor progress towards implementation of the Victorian Hepatitis B Strategy.

U

Understanding Quality Control Concepts

Education Presentations

In this lecture, you will review quality control concepts from the history of QC principles; and learn how to become aware of assumptions that underpin traditional approaches to QC. Please note, a free subscription is required for viewing this lecture. You can subscribe via the link above.

V

Validation of Dried Tube Sample Format Quality Controls for the Monitoring of Viral Load and Blood Screening Assays

Publications

This publication explores the use of Dried Tube Samples (DTS) for external quality assessment schemes (EQAS), with an international validation study demonstrating DTS is a suitable sample type for QC programs.

Visual and Statistical Assessment of Quality Control Results for the Detection of Hepatitis B Surface Antigen among Australian Blood Donors

Study

This study developed and used a graphical exploratory data analysis tool, providing increased understanding of the relationship between the results of quality control (QC) and donor samples tested in an IA.

Visual and Statistical Assessment of Quality Control Results for the Detection of Hepatitis-B Surface.

Study

This study developed and used a graphical exploratory date analysis tool which provided increased understanding of relationship between the results of quality control (QC) and donor samples tested in an IA.

W

What is the best external quality control sample for your laboratory?

Publications

This letter to the editor explores the question of 'What is the best external quality control sample for your laboratory?', by demonstrating that traditional laboratory approaches observed in core laboratory, are not appropriate for serology. And rather, that good QC practices, including software, can facilitate good laboratory testing.

Where to Now for Standardization of Anti-Rubella Virus IgG Testing

Publications

This publication explores and demonstrates the lack of standardization of rubella IgG testing, demonstrating that the problem remains, but the process for change has started.

Where traditional rules cannot tread: an interview with NRL scientists about Serology Testing QC.

QC QConnect

WHO international standard for anti-rubella: learning from its application

Standards

This standard describes the appropriateness of using 10 IU/mL as the cutoff for protection, and acknowledged the continuing role of RUBI-1-94 as a reference preparation to address analytical sensitivity and assay variation.

Z

Resouce - Page Content

Article Base & Training

Page last updated: 15 December 2022

A

A 16-year review of seroprevalence studies on measles and rubella. Vaccine

A Proposed Approach to Estimating Uncertainty of Measurement in Serological Assays

A Protocol for Validating Assembled Nucleic Acid Tests

A review of testing used in seroprevalence studies on measles and rubella Vaccine

Activating QConnect Membership and Accessing EDCNet

Administration Localisation

EDCNet Administration: Modify Contacts

Analysis of laboratory testing results collected in an enhanced chlamydia surveillance system in Australia

ASHM Testing Portal

Assessing Serology Quantitative Values in Infectious Diseases EQAS

Serological testing on the ADVIA Centaur system for human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in specimens from deceased and living individuals demonstrates equivalent results

B

Best Practice Laboratory Testing for Transfusion Transmissible Infections

Bleeding Love: NRL’s Plasma Biobank

C

Calculating Uncertainty of Measurement for Serology Assays by Use of Precision and Bias

Challenging QC Paradigm for Infectious Diseases

Characterization of Hepatitis B Precore/Core-Related Antigens

Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing

Comprehensive Quality Control Programme for Serology and Nucleic Acid Testing using an Internet based Application

Cost-benefit analysis of two quality control approaches for infectious disease testing

Counterpoint to the Letter to the Editor by Badrick and Parvin in regard to Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing

Covid-19 Testing: Maintaining Quality in a State of Emergency

Catalogue

D

Determination of quality control limits for serological infectious disease testing using historical data.

Does a Change in Quality Control Results Influence the Sensitivity of an anti-HCV Test?

E

EDCNet Troubleshooting Flow Chart

Editing QC Results

Entering QC Results

EQAS Catalogue 2025

EQAS Order Form

EQAS Standard Terms & Conditions

Evaluation of Eight Anti-rubella Virus Immunoglobulin G Immunoassays that Report Results in International Units per Milliliter

Evaluation of Three Immunoassays used for the Detection of Anti-Rubella Virus Immunglobulin M Antibodies

Evidence-based assessment of the application of Six Sigma to infectious disease serology quality control

Why NRL EQAS?

F

Final WHO SARS-CoV-2 serology test kit evaluation results

First Line Checklist

G

Guidelines for Approved Pathology Collection Centres (Requirements for medical pathology specimen collection) (Third Edition 2013)

Guidelines on the use of Serosurveys in Support of Measles and Rubella Elimination

H

High Rates of Undiagnosed HIV Infections in a Community Sample of Gay Men in Melbourne, Australia

HIV point-of-care tests: Conditions of approval for supply in Australia

I

Identifying the critical cut-points of a quality control process for serological assays: results from parametric and semiparametric regression models Accreditation and Quality Assurance

Implementation of Novel Quality Assurance Program for Hepatitis C Viral Load Point of Care Testing

Improving the coverage and accuracy of syphilis testing: The development of a novel rapid, point-of-care test for confirmatory testing of active syphilis infection and its early evaluation in China and South Africa

In-vitro diagnostic (IVD) medical devices regulations

Increased testing for Neisseria gonorrhoeae with duplex nucleic acid amplification tests in Australia: implications for surveillance

Increasing access by priority populations to Australian sexual health clinics

Introduction to NRL

Investigation into Low-Level Anti-Rubella Virus IgG Results Reported by Commercial Immunoassays

Investigation of the performance of serological assays used for Lyme disease testing in Australia

Isotype-switched immunoglobulin G antibodies to HIV Gag proteins may provide alternative or additional immune responses to ‘protective’ human leukocyte antigen-B alleles in HIV controllers

K

Key Facts in Covid-19 Testing

L

Low Genetic Diversity of Hepatitis B Virus Surface Gene amongst Australian Blood Donors

M

Manual for the Laboratory-based Surveillance of Measles, Rubella, and Congenital Rubella Syndrome

Monitoring the Control of Sexually Transmissible Infections and Blood-Borne Viruses: Protocol for the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance

MU Order Form

N

National Pathology Accreditation Advisory Council (NPAAC) Guidelines

NRL Workshop - Adelaide and Beyond

NRL Workshop - Sightseeing Tours and Charters

NRL Workshop- Pre & Post Touring Information

O

Overlays

P

Pathology laboratory surveillance in the Australian Collaboration for Coordinated Enhanced Sentinel Surveillance of sexually transmitted infections and blood borne viruses: Study Protocol

Policy analysis: User monitoring of in-vitro diagnostic medical devices used for near-patient testing of infectious diseases.

Post Market Monitoring of In-vitro Diagnostic Devices for Infectious Disease Near Patient Testing using Quality Assurance

Poster Post-market Evaluation of COVID-19 RATs for the TGA