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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Key Facts in Covid-19 Testing
Publications
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.
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.
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.
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’.
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.
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.
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.
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.
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.
Supplementary Information for all NRL EQAS Final Reports
EQAS Publications
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.
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.
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.

Publications

Higher human T-cell leukaemia virus type 1 (HTLV-1) proviral load is associated with end-stage kidney disease in Indigenous Australians: Results of a case-control study in central Australia

Talukder MRR, Walley R, Pham H, Schinke S, Woodman R, Wilson K, Sajiv C, Einsiedel L
J Med Virol. 2019 Oct;91(10):1866-1872.doi:10.1002/jmv.25532. Epub 2019 Jul 16

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

Kempster S L, Almond N, Dimech W, Grangeot-Keros L, Huzly D, Icenogle J, El Mubarak H S, Mulders M N, Nübling C M
[Epub ahead of print] September 6, 2019
The Lancet/Infectious Diseases
https://doi.org/10.1016/S1473-3099(19)30274-9

Page last updated: 20 May 2022