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The ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2

8 September 2021

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of all point-of-care (PoC) and laboratory tests on the Australian Register of Therapeutic Goods (ARTG) that are intended to identify individuals with COVID-19. The review verifies whether these tests can accurately detect emerging genetic variants of the SARS-CoV-2 virus; and complements the TGA's ongoing review of the overall performance of PoC tests.

The impact of the variants on test performance can be influenced by the variant's prevalence in the population (372kb) and the design of the test kit.

The TGA is monitoring the emerging variants of SARS-CoV-2 with at least 5% prevalence in the global population (i.e. mutations that occur in at least 5% of each viral variant) and will keep monitoring these variants as they continue to mutate.

This web page will be updated during the course of the post-market review with information about each test kit's performance against the variants.

Emerging variants

Like all viruses, SARS-CoV-2 can mutate over time, resulting in genetic variation among the viral strains circulating in the community. There are various potential consequences arising from these genomic mutations. The aim of this post-market review is to ensure all viral diagnostic tests continue to be able to detect known and emerging genetic variants. If the kits are not able to do so, this could potentially lead to false negatives and delay the treatment or isolation of individuals with COVID-19.

The variants are broken down into classifications, including variants of concern (VOC) and variants of interest (VOI). The nomenclature system and a list of the variants are updated by the World Health Organisation (WHO) and the Communicable Diseases Genomics Network (CGDN).

As at 31 August 2021, the variants of particular concern are:

WHO / CGDN Pango Lineage GISAID clade/linegae Nextstrain clade First identified

Alpha

B.1.1.7

GRY (formerly GR/501Y.V1)

20I (V1)

United Kingdom, Sep 2020

Beta

B.1.351

GH/501YV2

20H (V2)

South Africa, May 2020

Gamma

P.1

GR/501Y.V3

20J (V3)

Brazil, Nov 2020

Delta

B.1.617.2

G/478K.V1

21A

India, Oct 2020

Kappa

B.1.617.1

G/425R.V3

21B

India, Oct 2020

Delta Plus

AY.1, AY.2, AY.3

G/478K.V1

21A

Multiple Countries

Epsilon

B.1.427, B.1.429

GH/452R.V1

21C

United States, California

Eta

B.1.525

G/484K.V3

21D

United Kingdom/Nigeria

Zeta

P.2

GR/484K.V2

20B/S.484K

Brazil

Theta

P.3

GR

20B/S:265C

Philippines

Iota

B.1.526

GH/253G.V1

21F

United States, New York

United Kingdom/Nigeria

Lambda

C.37

GR/452Q.V1

21G

Peru, Lima

United States, New York

Information for laboratories and health professionals

The 3 main types of SARS-CoV-2 tests include:

  • Nucleic Acid Tests (NATs), which detect SARS-CoV-2 viral RNA
  • Rapid antigen tests (RATs), which detect antigen viral proteins from SARS-CoV-2
  • Serology tests, which detect IgM and/or IgG antibodies against SARS-CoV-2.

Laboratory and health professionals should be aware that:

  • Genetic variants of SARS-CoV-2 may yield false negative test results
  • NATs that utilise multiple genetic targets to determine a final result are less likely to be impacted by increased prevalence of genetic variants.

The TGA recommends that negative results be considered in combination with clinical observations, patient history and epidemiological information; and that repeat testing using a different test (with different genetic targets) be considered if COVID-19 is still suspected after a negative test result.

Throughout the course of the review, if the TGA identifies any test kits with a decrease in sensitivity against a variant, the TGA is working with the sponsor to add additional warnings and precautions into the Instructions for Use (IFU).

Post-market review of Nucleic Acid Tests

In Australia, at present, the most widely used COVID-19 diagnostic tests are SARS-CoV-2 NATs, which detect a range of different gene targets within the SARS-CoV-2 genome.

As NATs directly target the viral genome, they may be particularly vulnerable to sequence mutations, which could lead to false negative results. Therefore, it is important to assess the potential impact of emerging viral variants on the performance of NATs.

The TGA is undertaking desktop analysis of all NAT kits on the ARTG to determine whether they will be impacted by the known variants, with ongoing activity to assess their ability to detect all emerging variants of interest.

Information about each test kit's performance against the emerging variants of concern will be published on this webpage as it becomes available.

The performance of the following test kits has been validated against the Alpha, Beta, Gamma, Delta, Delta Plus, Kappa, Epsilon, Eta, Iota, Zeta, Theta and Lambda variants across 5% mutation prevalence (i.e. mutations that occur in at least 5% of each viral variant), as of 31 August 2021:

ARTG Sponsor name Manufacturer Model/ test kit name Review status

333161

Abacus dx Pty Ltd

CerTest Biotec SL (Spain)

VIASURE SARS-CoV-2 Real Time PCR Detection Kit

No impact identified on the test kit's performance.

335074

Abbott Australasia Pty Ltd Molecular Division

Abbott Molecular Inc

Alinity m SARS-CoV-2 AMP Kit and CTRL

No impact identified on the test kit's performance.

335074

Abbott Australasia Pty Ltd Molecular Division

Abbott Molecular Inc

Abbott RealTime SARS-CoV-2

No impact identified on the test kit's performance.

345457

Abbott Rapid Diagnostics Pty Ltd

Abbott Diagnostics Scarborough Inc also d/b/a Alere Scarborough Inc (United States of America)

ID NOW COVID-19

No impact identified on the test kit's performance.

336633

Australian Trefoil Health Technologies Pty Ltd

Wuhan EasyDiagnosis Biomedicine Co Ltd (China)

COVID-19 (SARS-CoV-2) Nucleic Acid Test kit

Cancelled by the sponsor.

332508

Becton Dickinson Pty Ltd

CerTest Biotec SL (Spain)

VIASURE SARS-CoV-2 S gene Real Time PCR Detection Kit

The test kit's ability to accurately detect the Alpha variant could be impacted due to a mutation in the kit's target site (S gene). These specific tests have not been distributed in Australia for diagnostic purposes.

Cancelled by the sponsor.

334514

Becton Dickinson Pty Ltd

Becton Dickinson and Company (United States of America)

BD SARS-CoV-2 Reagents for BD MAX™ System

No impact identified on the test kit's performance.

334043

BGI Health (AU) Company Pty Ltd

BGI Europe A/S (Denmark)

Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2

No impact identified on the test kit's performance.

224167

Biomerieux Australia Pty Ltd

BioFire Diagnostics LLC

BioFire Respiratory Panel 2.1 plus (RP2.1plus)

No impact identified on the test kit’s performance.

340774

Biomerieux Australia Pty Ltd

Biomerieux SA (France)

SARS-COV-2 R-GENE

No impact identified on the test kit’s performance.

332620

Cepheid Holdings Pty Ltd

Cepheid (United States of America)

Xpert Xpress SARS-COV2

No impact identified on the test kit's performance.

342730

Covid Solutions Pty Ltd

MiCoBioMed Co Ltd (Korea - Republic of)

Veri-Q PCR 316 COVID-19 Detection Kit

Cancelled by the TGA due to non-response to s41JA notice.

340804

DiaSorin Australia Pty Ltd

DiaSorin Molecular LLC (United States of America)

Simplexa COVID-19 Direct

No impact identified on the test kit's performance.

334983

EHEALTHY PTY LTD

Ustar Biotechnologies (Hangzhou) Co Ltd (China)

EasyNat Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)

Cancelled by sponsor.

340047

Elitechgroup Australia Pty Ltd

OSANG Healthcare Co Ltd (Korea - Republic of)

GeneFinder™ COVID-19 Plus RealAmp Kit

No impact identified on the test kit's performance.

346951

Emergence Technology Pty Ltd

Ustar Biotechnologies (Hangzhou) Ltd (China)

Diagnostic Kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay)

No impact identified on the test kit's performance.

334502

Genetic Signatures Ltd

Genetic Signatures Ltd (Australia)

EasyScreen™ SARS-CoV-2 Detection Kit (RP012)

No impact identified on the test kit’s performance

332963

Icon International Pty Ltd t/a Icon Medipharm

Shanghai ZJ Bio-Tech Co Ltd (China)

Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 genes)

No impact identified on the test kit's performance.

339846

Joy Surgical Pty Ltd

BioCore Co Ltd (Korea - Republic of)

Bio-Core 2019-nCoV Real Time PCR Kit

No impact identified on the test kit's performance.

338377

Labtest Medical Pty Ltd

General Biologicals Corp (Taiwan)

GB SARS-CoV-2 Real-Time RT-PCR

Cancelled by the sponsor.

345990

Marcel Equity Pty Limited

Coyote Bioscience Co Ltd (China)

DirectDetectTM SARS-C0V-2 Detection Kit (PCR-Flourescence Probe)

Cancelled by the sponsor.

344090

Pocratis Medical Pty Ltd

Shanghai ZJ Bio-Tech Co Ltd (China)

Novel Coronavirus (2019-nCoV) Real Time Multiplex
RT-PCR Kit (Detection for 3 Genes)

No impact identified on the test kit’s performance.

322230

Qiagen Pty Ltd

Qiagen GmbH

QIAstat-Dx Respiratory SARS-CoV-2 panel

No impact identified on the test kit's performance.

343260

Qiagen Pty Ltd

NeuMoDx Molecular Inc (United States of America)

NeuMoDxTM SARS-CoV-2 Assay

No impact identified on the test kit's performance.

299690

Roche Diagnostics Australia Pty Limited

Roche Molecular Systems Inc

cobas SARS-CoV-2 & Influenza A/B

No impact identified on the test kit's performance.

332509

Roche Diagnostics Australia Pty Limited

Roche Molecular Systems Inc (United States of America)

cobas® SARS-CoV-2

No impact identified on the test kit's performance.

335828

Sonictec

Jiangsu Bioperfectus Technologies Co Ltd (China)

COVID-19 Coronavirus Real Time PCR Kit

No impact identified on the test kit's performance.

343100

The Trustee for LILY CO UNIT TRUST

Da An Gene Co Ltd of Sun Yat-sen University (China)

Detection Kit for 2019 Novel Coronavirus (2019-nCoV) RNA (PCR-Fluorescence Probing)

Cancelled by the sponsor.

332640

Thermo Fisher Scientific Australia Pty Ltd

Life Technologies Corporation (United States of America)

TaqPath COVID-19 Combo Kit

The test kit's ability to accurately detect the Alpha and Eta variants could be impacted due to a mutation in one of the kit's target sites (S gene). As the test was designed with 3 targets, a dropout of one of the targets is unlikely affect the overall performance of the test kit. For further information please see: Emerging SARS-CoV-2 Variants and Mutations

338170

Viso Aesthetics Pty Ltd

Labgenomics Co Ltd (Korea - Republic of)

LabGunTM COVID-19 RT-PCR Kit

Cancelled by the sponsor.

334500

World Systems Corporation Pty Ltd

Kogene Biotech Co Ltd (Korea - Republic of)

PowerChekTM 2019-nCoV Real-time PCR Kit

Cancelled by the TGA

Post-market review of Antigen and Rapid Antigen Tests

RATs are intended for use at the point of care to detect the presence of viral proteins from SARS-CoV-2. They may be used as a presumptive test to detect SARS-CoV-2 infection.

Mutations in the protein target of the genome may alter the structure of a viral protein and as a result the test may no longer be able to detect the virus, leading to false negative results. A false negative result may also occur if the virus has acquired amino acid mutation(s) in the epitope recognised by the antibody used in the test.

The TGA is undertaking desktop analyses of all laboratory antigen and RATs included in the ARTG to determine whether they will be impacted by the current known variants, with ongoing activity to assess their ability to detect all emerging variants of interest.

The manufacturers of these kinds of tests have provided the TGA with study data to validate the performance of the kits, including in-silico analysis, recombinant protein studies, live virus studies, and inactivated virus studies against the Alpha, Beta, Gamma, Delta, Delta Plus, Kappa, Epsilon, Eta, Iota, Zeta, Theta and Lambda variants

The TGA is reviewing the above information to ensure the manufacturer has captured the emerging variants with at least 5% prevalence in the global population (i.e. mutations that occur in at least 5% of each viral variant) in their studies.

The review is on-going and information about the performance of each RAT against the variants will be published on this webpage as it becomes available.

Note: The TGA is requesting information for all the variants listed above to ensure the manufacturers are undertaking proactive monitoring.

The manufacturers may not have finalised their evaluation for some of the variants due to lower prevalence or recent emergence, or the data may still be under review by the TGA, therefore not all test kits for all variants are listed below.

As of 31 August 2021, the following test kits have evidence to support their continued performance with the variants specified below:

ARTG Sponsor name Manufacturer Test kit name Review status

345192

Abbott Rapid Diagnostics Pty Ltd

Abbott Rapid Diagnostics Jena GmbH (Germany)

Panbio™ COVID-19 Ag Rapid Test Device (Nasopharyngeal)

Evidence of performance against Alpha, Beta, Gamma, Delta, Kappa, Zeta, Theta and Eta variants.

346587

Atomo Diagnostics Limited

Access Bio Inc (United States of America)

Atomo Covid-19 Antigen Test

Evidence of performance against Alpha, Beta, Delta, Kappa, Epsilon and Lambda variants.

344030

Becton Dickinson Pty Ltd

Becton Dickinson and Company (United States of America)

BD Veritor™ System for Rapid Detection of SARS-CoV-2

Evidence of performance against Alpha, Beta, Gamma, Delta, Kappa and Iota variants.

345219

Biocelect Pty Ltd

SD Biosensor Inc (Korea - Republic of)

STANDARD™ Q COVID-19 Ag Test

Evidence of performance against Alpha, Beta, Gamma, Delta, Kappa, Epsilon, Iota, Lambda and Zeta variants.

346643

Emergence Technology Pty Ltd

Assure Tech (Hangzhou) Co Ltd (China)

COVID-19 Antigen Rapid Test Device

Evidence of performance against Alpha, Beta, Gamma, Delta and Kappa variants.

370592

Health Vision Australasia Pty Ltd

Arista Biotech Pte Ltd (Singapore)

ARISTA™ COVID-19 Antigen Rapid Test

Evidence of performance against Alpha, Beta, Gamma, Delta, Kappa and Epsilon variants.

336146

Innovation Scientific Pty Ltd

Innovation Scientific Pty Ltd

InnoScreen COVID-19 Antigen Rapid Test Device

Evidence of performance against Alpha, Beta, Gamma, Delta, Kappa and Epsilon variants.

343293

Life Bioscience Pty Ltd

BioNote Inc (Korea - Republic of)

NowCheck COVID-19 Antigen Test

Evidence of performance against Alpha, Beta, Gamma and Delta variants.

349933

Nature's Family Australia Pty Ltd

GenBody Inc (Korea - Republic of)

GenBody COVID-19 Ag

Evidence of performance against Alpha, Beta, Gamma, Delta, Epsilon, Eta, Iota and Zeta variants.

342512

Pantonic Health Pty Ltd

Access Bio Inc

CareStart™ COVID-19 Antigen test kit

Evidence of performance against Alpha, Beta, Delta, Kappa, Epsilon and Lambda variants.

342390

Point of Care Diagnostics Australia Pty Ltd

Quidel Corporation (United States of America)

Sofia® SARS Antigen FIA

Evidence of performance against Alpha, Beta, and Gamma variants.

352250

Roche Diagnostics Australia Pty Limited

SD Biosensor Inc (Korea - Republic of)

SARS-CoV-2 Rapid Antigen Test

Evidence of performance against Alpha, Beta, Gamma, Delta, Kappa, Epsilon, Iota and Zeta variants.

348890

Stonestar Wholesale Pty Ltd

VivaChek Biotech (Hangzhou) Co Ltd (China)

VivaDiag™ SARS-CoV-2 Ag Rapid Test

Evidence of performance against Alpha, Beta, Gamma, Delta and Epsilon variants.

347092

SureScreen Australia Pty Limited

BTNX Inc (Canada)

Surescreen Diagnostics COVID-19 Antigen Rapid Test

Evidence of performance against the Alpha, Beta, Gamma and Delta variants.

Post-market review of Serology Tests

Serology tests are designed to detect antibody responses developed against the viral antigen. Structural alterations in antibodies as a result of mutations influence the binding efficiency to the target regions in the test kit.

Information about each test kit's performance against the variants will be published on this webpage as it becomes available.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.