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The WHO said antibody tests can show if a person has contracted the virus, but not necessarily if they’re immune to infection.
Science surrounding antibody testing is still developing, too, and concerns have emerged around the tests being inaccurate, rushed, and improperly marketed. More than 100 organisations are selling such tests in the US, but the US Food and Drug Administration has only approved a few.
Germany’s antibody testing could help provide more information on how many people have antibodies, at what levels, and what protection they could confer against the novel virus.

COVID-19 test kits included in the ARTG for legal supply in Australia
1 July 2020
The TGA has approved the following tests for inclusion in the Australian Register of Therapeutic Goods (ARTG).


Please note:
Conditions have been imposed on the supply of COVID-19 serology-based point of care tests. Further information can be found at: Legal supply of COVID-19 test kits.
The Peter Doherty Institute for Infection and Immunity (the Doherty Institute) has been engaged by the Department of Health to assist with the post-market validation of new COVID-19 rapid tests to inform their best use.
Only the approved Sponsor (i.e. importer) listed in the table below, or a person acting on their behalf (i.e., the person has a distribution arrangement with the sponsor), can supply the device.
*Note: Some point-of-care tests are not intended for use with finger-prick (finger-stick) specimens. Please refer to the instructions for use for each test to determine intended specimen types.

 

COVID-19 test kits included on the ARTG for legal supply in Australia
Displaying 1 - 67 of 67

 

 

Laboratory
Nucleic Acid Test
Manufacturer: Abbott Australasia Pty Ltd Molecular Division
Name of test: Abbott Real Time SARS-CoV-2
Australian sponsor: Abbott Australasia Pty Ltd Molecular Division

Date approved for supply: 17 Apr 2020


Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Atlaslink Beijing Technology Co Ltd (China)
Name of test: NOVA Test® COVID-19 IgG/IgM Antibody Test (Colloidal Gold)
Australian sponsor: Adelco Pharmaceuticals (Australia) Pty Ltd

Date approved for supply: 18 May 2020

Laboratory
Nucleic Acid Test
Manufacturer: AusDiagnostics Pty Ltd (Australia)
Name of test: AusDiagnostics respiratory virus panel (including SARS-CoV-2) test
Australian sponsor: AusDiagnostics Pty Ltd

Date approved for supply: 19 Mar 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Becton Dickinson and Company (United States of America)
Name of test: BD SARS-CoV-2 Reagents for BD MAX™ System
Australian sponsor: Becton Dickinson Pty Ltd

Date approved for supply: 17 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)
Name of test: Wantai SARS-CoV-2 Ab Rapid Test kit
Australian sponsor: Life Clinic Australia Pty Ltd

Date approved for supply: 27 Mar 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: BGI Europe A/S (Denmark)
Name of test: Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2
Australian sponsor: BGI Health (AU) Company Pty Ltd

Date approved for supply: 10 Apr 2020

PCR technology is being used a lot in assessment. PCR Technology

Laboratory
Immunoassay
Manufacturer: Bio-Rad (France)
Name of test: Platelia SARS-CoV-2 Total Ab
Australian sponsor: Bio-Rad Laboratories Pty Ltd

Date approved for supply: 23 Jun 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Cellex Inc. (United States of America)
Name of test: Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit
Australian sponsor: Medicision Pty Ltd

Date approved for supply: 31 Mar 2020

 

Laboratory/Point-of-care test*
Nucleic Acid Test
Manufacturer: Cepheid (USA)
Name of test: Xpert® Xpress SARS-CoV-2
Australian sponsor: Cepheid Holdings Pty Ltd

Date approved for supply: 22 Mar 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: CerTest Biotec SL (Spain)
Name of test: VIASURE SARS-CoV-2 Real Time PCR Detection Kit
Australian sponsor: Abacus dx Pty Ltd

Date approved for supply: 31 Mar 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: CerTest Biotec SL (Spain)
Name of test: VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit
Australian sponsor: Becton Dickinson Pty Ltd

Date approved for supply: 21 Mar 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: CTK Biotech Inc. (United States of America)
Name of test: Aridia COVID-19 Real-Time PCR Test
Australian sponsor: MD Solutions Australasia Pty Ltd

Date approved for supply: 24 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: CTK Biotech Inc. (USA)
Name of test: OnSite COVID-19 IgG/IgM Rapid Test
Australian sponsor: MD Solutions Australasia Pty Ltd

Date approved for supply: 19 Mar 2020

 

Laboratory
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 ELISA (IgG)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

Date approved for supply: 18 May 2020

 

Laboratory
Nucleic Acid Test

Date approved for supply: 18 May 2020Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: EURORealTime SARS-CoV-2
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

 

Laboratory
Immunoassay
Manufacturer: EUROIMMUN Medizinische Labordiagnostika AG (Germany)
Name of test: Anti-SARS-CoV-2 ELISA (IgA)
Australian sponsor: ESL Biosciences Australia 2012 Pty Ltd

Date approved for supply: 18 May 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: GenBody Inc. (Korea - Republic of)
Name of test: GenBody COVID-19 IgM/IgG
Australian sponsor: Biovent Consulting Pty Ltd

Date approved for supply: 28 Apr 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: General Biologicals Corp (Taiwan)
Name of test: GB SARS-CoV-2 Real Time RT-PCR
Australian sponsor: Labtest Medical Pty Ltd

Date approved for supply: 25 Jun 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Genetic Signatures Ltd (Australia)
Name of test: EasyScreen™ SARS-CoV-2 Detection Kit
Australian sponsor: Genetic Signatures Ltd

Date approved for supply: 13 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Australian sponsor: Allsafe Medical Pty Ltd

Date approved for supply: 17 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Australian sponsor: Tayler Dental Consulting Pty Ltd

Date approved for supply: 9 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Guanngzhou Wondfo Biotech Co Ltd (China)
Name of test: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Australian sponsor: Cellmid Limited

Date approved for supply: 25 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Name of test: 2019-n-CoV IgG/IgM Rapid Test Cassette
Australian sponsor: AM Diagnostics

Date approved for supply: 23 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Medsupply Australia Pty Ltd

Date approved for supply: 4 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: APAC Security Pty Ltd

Date approved for supply: 26 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Ausliance Group Pty Ltd

Date approved for supply: 4 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)
Name of test: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Australian sponsor: Complementary Medicines Group Pty Ltd

Date approved for supply: 6 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Name of test: 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
Australian sponsor: Solasta Life Pty Ltd

Date approved for supply: 16 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Healgen Scientific Limited Liability Company (United States of America)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Southwind International Pty Ltd

Date approved for supply: 29 Apr 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Hologic Inc. (United States of America)
Name of test: Aptima® SARS-CoV-2 Assay
Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd

Date approved for supply: 29 Jun 2020

 

 

Laboratory
Nucleic Acid Test
Manufacturer: Hologic Inc. (USA)
Name of test: Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System)
Australian sponsor: Hologic (Australia & New Zealand) Pty Ltd

Date approved for supply: 20 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Innovation Scientific Pty Ltd (Australia)
Name of test: InnoScreenTM COVID-19 IgG/IgM Rapid Test
Australian sponsor: Innovation Scientific Pty Ltd

Date approved for supply: 11 May 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Name of test: 2019-nCov Ab Test (Colloidal Gold)
Australian sponsor: Laser Corporation Holdings Pty Limited

Date approved for supply: 16 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Name of test: 2019-nCoV Ab Test (Colloidal Gold)
Australian sponsor: TrendBio Pty Ltd

Date approved for supply: 11 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Name of test: 2019-nCoV Ab Test (Colloidal Gold)
Australian sponsor: AM Diagnostics

Date approved for supply: 20 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Name of test: 2019-nCoV Ab Test (Colloidal Gold)
Australian sponsor: Aurora Future Education Group

Date approved for supply: 4 Apr 2020

 

 

Laboratory
Nucleic Acid Test
Manufacturer: Jiangsu Bioperfectus Technologies Co Ltd (China)
Name of test: COVID-19 Coronavirus Real Time PCR Kit
Australian sponsor: Sonictec

Date approved for supply: 5 May 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Kogene Biotech Co Ltd (Korea - Republic of)
Name of test: PowerChekTM 2019-nCoV Real-time PCR Kit
Australian sponsor: World Systems Corporation Pty Ltd

Date approved for supply: 16 Apr 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Labgenomics Co Ltd (Korea - Republic of)
Name of test: LabGun™ COVID-19 RT-PCR Kit
Australian sponsor: Viso Aesthetics Pty Ltd

Date approved for supply: 23 Jun 2020

 

 

Laboratory
Nucleic Acid Test
Manufacturer: Life Technologies Corporation (USA)
Name of test: TaqPath COVID-19 Combo Kit
Australian sponsor: Life Technologies Australia Pty Ltd

Date approved for supply: 24 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Nantong Egens Biotechnology Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Kit
Australian sponsor: Lavinia Medical Pty Ltd

Date approved for supply: 27 May 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Newscen Coast Bio-Pharmaceutical Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Kissun Pharmaceuticals Pty Ltd

Date approved for supply: 23 Jun 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: NTBIO Diagnostics Inc. (Canada)
Name of test: NTBIO One Step Rapid Test - COVID-19 IgG/IgM Antibody Test
Australian sponsor: Healtheguru Pty Ltd

Date approved for supply: 27 May 2020

 

Laboratory
Immunoassay
Manufacturer: Ortho-Clinical Diagnostics (United Kingdom)
Name of test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total
Australian sponsor: Ortho-Clinical Diagnostics Australia Pty Ltd

Date approved for supply: 19 Jun 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: PCL Inc. (Korea - Republic of)
Name of test: PCL COVID19 IgG/IgM Rapid Gold
Australian sponsor: Haemokinesis Pty Ltd

Date approved for supply: 1 May 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Qiagen GmbH
Name of test: QIAstat-Dx® Respiratory SARS-CoV-2 Panel
Australian sponsor: Qiagen Pty Ltd

Date approved for supply: 8 May 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Qingdao Hightop Biotech Co Ltd (China)
Name of test: SARS-CoV-2 IgM/IgG Antibody Rapid Test
Australian sponsor: Envon Pty Ltd

Date approved for supply: 31 Mar 2020

 

Laboratory
Immunoassay
Manufacturer: Roche Diagnostics GmbH (Germany)
Name of test: Elecsys Anti-SARS-CoV-2
Australian sponsor: Roche Diagnostics Australia Pty Limited

Date approved for supply: 20 May 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Roche Molecular Systems Inc. (USA)
Name of test: cobas® SARS-CoV-2
Australian sponsor: Roche Diagnostics Australia Pty Limited

Date approved for supply: 20 Mar 2020

 

Point-of-care test*
Nucleic Acid Test
Manufacturer: Sansure Biotech Inc. (China)
Name of test: Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)
Australian sponsor: Allsafe Medical Pty Ltd

Date approved for supply: 29 Jun 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Seegene Inc. (Korea - Republic of)
Name of test: Allplex™ 2019-nCoV Assay
Australian sponsor: Integrated Sciences Pty Ltd

Date approved for supply: 27 Mar 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Shanghai Fosun Long March Medical Science Co Ltd (China)
Name of test: Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit
Australian sponsor: Alma Lasers Australia Pty Ltd

Date approved for supply: 8 May 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Shanghai ZJ Bio-Tech Co Ltd (China)
Name of test: Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 genes)
Australian sponsor: Icon International Pty Ltd t/a Icon Medipharm

Date approved for supply: 22 Mar 2020

 

Laboratory
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc. (United States of America)
Name of test: ADVIA Centaur® SARS-CoV-2 Total (COV2T) assay
Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 5 Jun 2020

 

Laboratory
Immunoassay
Manufacturer: Siemens Healthcare Diagnostics Inc. (United States of America)
Name of test: Atellica® IM SARS-CoV-2 Total (COV2T) assay
Australian sponsor: Siemens Healthcare Pty Ltd

Date approved for supply: 5 Jun 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Suzhou Sym-Bio Lifescience Co Ltd (China)
Name of test: PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay
Australian sponsor: PerkinElmer

Date approved for supply: 2 Jun 2020

 

Laboratory/Point-of-care test*
Nucleic Acid Test
Manufacturer: Ustar Biotechnologies (Hangzhou) Co Ltd (China)
Name of test: EasyNat Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)
Australian sponsor: EHEALTHY PTY LTD

Date approved for supply: 23 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: VivaCheck Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test
Australian sponsor: Endo X Pty Ltd

Date approved for supply: 20 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test
Australian sponsor: Device Technologies Australia Pty Ltd

Date approved for supply: 26 Mar 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Name of test: VivaDiag™ COVID-19 IgM/IgG Rapid Test
Australian sponsor: Stonestar Wholesale Pty Ltd

Date approved for supply: 6 Apr 2020

 

Laboratory
Nucleic Acid Test
Manufacturer: Wuhan EasyDiagnosis Biomedicine Co Ltd (China)
Name of test: COVID-19 (SARS-CoV-2) Nucleic Acid Test kit
Australian sponsor: Australian Trefoil Health Technologies Pty Ltd

Date approved for supply: 19 May 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Wuhan EasyDiagnosis Biomedicine Co Ltd (China)
Name of test: SARS-CoV-2 IgM/IgG Antibody Test Kit
Australian sponsor: Australian Trefoil Health Technologies Pty Ltd

Date approved for supply: 19 May 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)
Name of test: COVID 19 IgG/IgM Rapid Test Cassette
Australian sponsor: Expia Pty Ltd

Date approved for supply: 24 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Amandla China Pty Limited

Date approved for supply: 1 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)
Name of test: COVID-19 IgG/IgM Rapid Test Cassette
Australian sponsor: Onsite Diagnostics Pty Ltd

Date approved for supply: 14 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Zhuhai Livzon Diagnostics Inc. (China)
Name of test: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
Australian sponsor: Marcel Equity Pty Limited/Avania PL

Date approved for supply: 23 Apr 2020

 

Point-of-care test*
Lateral Flow IgG/IgM
Manufacturer: Zhuhai Livzon Diagnostics Inc. (China)
Name of test: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
Australian sponsor: Emergence Technology Pty Ltd

Date approved for supply: 5 May 2020
Category: Medical devices/IVDs
Tags: medical devices, COVID-19 tests
URL:https://www.tga.gov.au/node/904122

 

]
OTHER TESTING KITS

The CDC has developed a laboratory test to help estimate how many people in the United States have been infected with SARS-CoV-2, the virus that causes COVID-19. Clinicians and researchers refer to this as a serology test, and many commercial laboratories call it an antibody test. CDC is using this serologic (antibody) test to evaluate the performance of commercial antibody tests. CDC will develop guidance for the use of antibody tests in clinical and public health settings.


An antibody test looks for the presence of antibodies, which are specific proteins made in response to infections. Antibodies are detected in the blood of people who are tested after infection; they show an immune response to the infection. Antibody test results are especially important for detecting previous infections in people who had few or no symptoms.


CDC’s serologic test has been designed and validated for surveillance and research purposes. It is designed to estimate the percentage of the U.S. population previously infected with the virus – information needed to guide the response to the pandemic and protect the public’s health.


The CDC test is not currently designed to test individuals who want to know if they have been previously infected with SARS-CoV-2. Commercial tests are available to provide test results to individuals.

 

In a Lancet Infectious Diseases comment, two Johns Hopkins University epidemiologists note that serological analysis ‘can be useful for contact tracing in urban environments and linking clusters of cases retrospectively to delineate transmission chains and ascertain how long transmission has been ongoing or to estimate the proportion of asymptomatic individuals in the population’.

These tests have been controversial to date, with Doherty Institute experts cautioning in a recent post-market review that antibody tests are not suitable for diagnosis of acute COVID-19 and have limited clinical utility.

Early antibody tests bought in bulk by the Australian Government have been significantly less reliable than claimed in independent testing, according to reports in Nine Newspapers, while the UK Government purchased millions of tests that did not work.

 

The TGA is now reviewing all serology-based point-of-care tests for SARS-CoV-2 to ‘verify their ability to detect antibodies to COVID-19’.

Newer tests are showing more promise, however, with experts suggesting the new Roche test now approved for use in the UK and the cPass test developed in Singapore may have overcome these issues.

The TGA this week approved the use of the Roche test for medical use in Australia, while the cPass test is understood to be undergoing testing at the Doherty Institute.

Immunology professor Ian Frazer told newsGP, the Roche test has been put through ‘rigorous quality control’ with 99.5% sensitivity and 100% specificity for SARS-CoV-2 antibodies, and has been approved for emergency use by the US Food and Drug Administration.

University of Queensland virologist Associate Professor Ian Mackay told newsGP the Roche test is much more reliable than some other lateral flow tests at detecting the presence of the immunoglobulin G antibody.

‘[However], it doesn’t seem to specifically determine whether those antibodies are neutralising,’ he said.

‘In the early days, knowing this information is important. Later, we may better understand how often neutralising antibodies are produced in a recovering patient.’

Associate Professor Mackay said the new cPass test developed by Duke-NUS in Singapore is ‘exciting’ given it is a rapid kit-based test that can specifically identify neutralising antibodies in patients who have been infected with SARS-CoV-2, with results available within one hour.

He said the cPass test would be a ‘fantastic addition to the diagnostic armamentarium’.

‘Being able to identify these antibodies without reliance on traditional culture-based methods makes for faster, safer testing,’ he said.

‘The test identified whether a patient is likely producing not just any old antibodies, but those that can protect them from future disease by binding to and disabling the virus, should the person ever be reinfected.’

 

Two Johns Hopkins University epidemiologists have noted that serological analysis ‘can be useful for contact tracing in urban environments and linking clusters of cases retrospectively to delineate transmission chains’.

 

However, the tests may improve the ability to detect hidden clusters of the virus, in combination with testing of sewage and genomic analysis.

Researchers from the Doherty Institute and Victorian Infectious Diseases Reference Laboratory this week announced they had used genomic analysis to detect 76 distinct genomic clusters in Victoria, representing 75% of the cases.

These include large clusters ‘associated with social venues, healthcare facilities and cruise ships,’
  
The ability to detect hidden clusters is gaining importance as more evidence comes in suggesting that the SARS-CoV-2 virus relies on super-spreaders for the bulk of its transmission, while many carriers do not transmit the virus at all.

Microbiologist and science writer Kai Kupferschmidt notes in Science that SARS-CoV-2 ‘seems especially prone to attacking groups of tightly connected people while sparing others’ – similar to the related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

‘We are certainly seeing a lot of concentrated clusters where a small proportion of people are responsible for a large proportion of infections,’ University of Hong Kong modeller Gabriel Leung told Science.

That seems to accord with emerging patterns in Australia, where clusters have popped up in meat works and aged care facilities even as the virus has been broadly contained.