Post-market review of nucleic acid tests
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.
Nucleic acid tests (NATs) detect a range of different gene targets within the SARS-CoV-2 genome and 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 continues to monitor all NAT kits included in the ARTG to determine whether they will be impacted by the known variants of COVID-19. The TGA continues to focus on the Variants of Concern, such as Omicron, and associated sub lineages.
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 following variants:
- 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.
- Mu variants (B.1.621) across 5% mutation prevalence as of 1 December 2021; and
- Delta (B.1.617.2 and AY sub-lineages) and Omicron variant (B.1.1.519 and BA.2 sub lineage) across 5% mutation prevalence, as of 3 March 2022.
- Omicron (BA. 4 and BA.5 sub lineages) across 5% mutation prevalence, as of 24 January 2023.
- Omicron subvariants across 5% mutation prevalence, as of 20 February 2023: BA.2.75, BA.2.75.2, BA.2.75.4, BA.5.2, BF.7, BM.1.1.1, BN.1, BN.1.2, BN.1.3, BQ.1, BQ.1.1, BQ.1.23, BR.2, BR.2.1, CH.1.1, CH.1.1.1, XBB.1, XBB.1.5, XBC.1, XBC.1.1 and XBF.
Nucleic Acid self-tests
The TGA has approved COVID-19 nucleic acid amplification self-tests for supply in Australia. Nucleic acid self-tests are subject to the same conditions as self-test rapid antigen tests (RATs).
|
ARTG |
Sponsor name |
Manufacturer |
Model/ test kit name |
Review status |
|---|---|---|---|---|
|
390609 |
Elamaan Health Pty Ltd |
Ustar Biotechnologies (Hangzhou) Ltd (China) |
EasyNAT COVID-19 RNA Test (self-test) |
No impact identified on the test kit's performance. |
|
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 (United States of America) |
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 (United States of America) |
Abbott RealTime SARS-CoV-2 |
No impact identified on the test kit’s performance. |
|
386639 |
Abbott Australasia Pty Ltd Molecular Division |
Abbott Molecular Inc (United States of America) |
Alinity m Resp-4-Plex AMP kit |
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. |
|
352900 |
Accelagen Pty Ltd |
Accelerate Technologies Pte Ltd (DxD Hub) (Singapore) |
Resolute 2.0 SARS CoV-2 Detection Kit |
Cancelled by the sponsor. |
|
368051 |
Accelagen Pty Ltd |
AMT Pte Ltd (Singapore) |
RESOLUTE 2.0 |
No impact identified on the test kit’s performance. |
|
338589 |
ALLSAFE MEDICAL PTY LTD |
SANSURE BIOTECH INC (China) |
Novel Coronavirus(2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) |
No impact identified on the test kit’s performance. |
|
336018 |
Alma Lasers Australia Pty Ltd |
Shanghai Fosun Long March Medical Science Co Ltd (China) |
Novel Coronavirus (2019-nCoV) RT-PCR Detection Kit |
Cancelled by the sponsor. |
|
235809 |
AusDiagnostics |
AusDiagnostics |
Upper Respiratory Pathogens (mulitplex PCR) |
No impact identified on the test kit’s performance. |
|
236377 |
AusDiagnostics Pty Ltd |
AusDiagnostics (Australia) |
Upper Respiratory Pathogens (mulitplex PCR) |
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.
|
|
308340 |
Becton Dickinson Pty Ltd |
CerTest Biotec SL |
VIASURE SARS-CoV-2, Flu (A+B) & RSV |
No impact identified on the test kit’s performance. |
|
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. |
|
334043 |
BGI Health (AU) Company Pty Ltd |
BGI Europe A/S |
Real time fluorescent RT PCR kit for detecting SARS CoV 2 (dual target) |
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. |
|
231513 |
Cepheid Holdings Pty Ltd |
Cepheid (United States of America) |
Xpert Xpress SARS-CoV-2/Flu/RSV |
No impact identified on the test kit’s performance. |
|
231513 |
Cepheid Holdings Pty Ltd |
Cepheid (United States of America) |
Xpert Xpress CoV-2/Flu/RSV plus |
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 the 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. |
|
336561 |
ESL Biosciences Australia 2012 Pty Ltd |
EUROIMMUN Medizinische Labordiagnostika AG (Germany) |
EURORealTime SARS-CoV-2 |
No impact identified on the test kit’s performance. |
|
340779 |
Gene Target Solutions Pty Ltd |
Co-Diagnostics Inc (United States of America) |
Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test |
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. |
|
351643 |
HA TECH PTY LTD |
HA TECH PTY LTD (Australia) |
RT-PCR IVD MEDICAL DEVICE FOR 2019 NOVEL CORONAVIRUS (SARS-COV-2) NUCLEIC ACID DETECTION |
No impact identified on the test kit’s performance |
|
296043 |
Hologic (Australia & New Zealand) Pty Ltd |
Hologic Inc (United States of America) |
Aptima SARS-CoV-2/Flu Assay |
No impact identified on the test kit’s performance |
|
338553 |
Hologic (Australia & New Zealand) Pty Ltd |
Hologic Inc (United States of America) |
Aptima® SARS-CoV-2 Assay |
No impact identified on the test kit’s performance |
|
332641 |
Hologic (Australia & New Zealand) Pty Ltd |
Hologic Inc (United States of America) |
Panther Fusion® SARS-CoV-2 Assay (Panther Fusion® System) |
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. |
|
239512 |
Integrated Sciences Pty Ltd |
Seegene Inc (Korea - Republic of) |
Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay |
There is a 100-fold reduction in N gene detection for the Alpha variant and a 10 fold reduction for the Eta variant due to mutations in the target site. |
|
239512 |
Integrated Sciences Pty Ltd |
Seegene Inc (Korea - Republic of) |
Allplex RV Master Assay |
No impact identified on the test kit’s performance |
|
333060 |
Integrated Sciences Pty Ltd |
Seegene Inc (Korea - Republic of) |
Allplex™ 2019-nCoV Assay |
There is drop-out in the detection of RdRP gene for the Delta variant due to a mutation in the target site. |
|
333060 |
Integrated Sciences Pty Ltd |
Seegene Inc (Korea - Republic of) |
Allplex™ SARS-CoV-2 Assay |
No impact identified on the test kit’s performance. |
|
333060 |
Integrated Sciences Pty Ltd |
Seegene Inc (Korea - Republic of) |
Allplex SARS-CoV-2 Fast PCR Assay |
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. |
|
335082 |
MD Solutions Australasia Pty Ltd |
CTK Biotech Inc (United States of America) |
Aridia COVID-19 Real-Time PCR Test |
No impact identified on the test kit’s performance. |
|
343259 |
Pacific Laboratory Products Pty Ltd |
Primer Design Limited (United Kingdom) |
genesig® Real-Time PCR Coronavirus COVID-19 |
Cancelled by the sponsor. |
|
342512 |
Pantonic Health Pty Ltd |
Access Bio Inc (United States of America) |
CareStart™ COVID-19 MDx RT-PCR |
Cancelled by the TGA due to non-response to s41JA notice. |
|
337365 |
PerkinElmer |
Suzhou Sym-Bio Lifescience Co Ltd (China) |
PerkinElmer® SARS-CoV-2 Real-time RT-PCR Assay |
No impact identified on the test kit’s performance. |
|
342770 |
PerkinElmer |
Wallac Oy (Finland) |
SARS-CoV-2 RT-qPCR Reagent kit |
No impact identified on the test kit’s performance. |
|
349811 |
PerkinElmer |
Suzhou Sym-Bio Lifescience Co Ltd (China) |
PKamp™ Respiratory SARS-CoV-2 RT-PCR Panel |
No impact identified on the test kit’s performance. |
|
344090 |
Pocratis Medical Pty Ltd |
Shanghai ZJ Bio-Tech Co Ltd (China) |
Novel Coronavirus (2019-nCoV) Real Time Multiplex |
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) |
NeuMoDx™ SARS-CoV-2 Assay |
No impact identified on the test kit’s performance. |
|
368470 |
Qiagen Pty Ltd |
NeuMoDx Molecular Inc (United States of America) |
NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Strip |
No impact identified on the test kit’s performance. |
|
356659 |
Rachael Flood |
Chaozhou Hybribio Biochemistry Ltd (China) |
COVID-19 Real-Time PCR kit (HBRT-COVID-19) |
The impact of the Omicron variant on the test kit's performance is under investigation. |
|
299690 |
Roche Diagnostics Australia Pty Limited |
Roche Molecular Systems Inc (United States of America) |
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. |
|
372688 |
SpeeDx Pty Ltd |
SpeeDx Pty Ltd (Australia) |
PlexPCR® SARS-CoV-2 |
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 |
Life Technologies Australia Pty Ltd (Formerly 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 and Omicron variants could be impacted due to a mutation in one of the kit's targets sites (S gene). As the test was designed with 3 targets, a dropout of one of the targets is unlikely to affect the overall performance of the test kit. Please see further information from the manufacturer. |
|
342337 |
Vela Diagnostics Australia Pty Ltd |
Vela Operations Singapore Pte Ltd (Singapore) |
ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 |
The test kit’s ability to detect the SARS-CoV-2 Omicron variant (B.1.1.529) could be impacted by certain mutations in the N-gene. However, as the test was designed with two gene targets, a dropout of the N-gene is unlikely to affect the overall performance of the test kit. |
|
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 |