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Post market review of COVID-19 point-of-care tests
In response to the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) is currently undertaking an expedited approval process for inclusion of COVID-19 tests on the Australian Register of Therapeutic Goods (ARTG). Inclusion on the ARTG is based on certified manufacturer’s evidence and studies provided at the time of application. Supply of test kits can only occur under certain conditions, including that further information must be provided to the TGA to support the performance of these devices.
The TGA maintains a list of the sponsors (the person or company legally responsible for the product) of COVID-19 tests, including point-of-care tests, that are currently available and included on the ARTG. COVID-19 point-of-care tests included on the ARTG can only be supplied to, and are intended for use by, healthcare professionals. The majority are serology-based tests, which rely on the detection of Immunoglobulin G (IgG) and Immunoglobulin M (IgM) (antibodies to COVID-19).
Accurate identification of a COVID-19 infection based on serology results, particularly those obtained from rapid tests used at the point-of-care, requires an understanding of the antibody response profile. There is a high likelihood of obtaining a false negative result if testing is performed in the early stages of infection, before an individual has developed antibodies. There is also evidence that some individuals may not develop antibodies to COVID-19. Therefore, an additional condition has been imposed on serology-based COVID-19 point-of-care tests to ensure that they are only supplied to, and used by, specified health professionals (e.g. medical practitioners) who can provide appropriate advice and treatment if required. For further information, see Legal supply of COVID-19 test kits.
The TGA is now reviewing all serology-based COVID-19 point-of-care tests included on the ARTG to verify their ability to detect antibodies to COVID-19, taking into consideration the timeframes for an individual to develop detectable levels of antibody.
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 these tests to inform their best use. Other evaluations undertaken by Australian laboratories, or evaluations performed on behalf of other international regulators, may be taken into consideration by the TGA.
The TGA has contacted all sponsors of serology-based COVID-19 point-of-care tests currently included on the ARTG to request they provide further information about the devices, their distribution, and samples of these devices for evaluation.
Once the Doherty Institute validations are completed, the following table will show any regulatory or other action taken.
We anticipate that following the review of the devices included on the ARTG there will be a clearer understanding of the role these tests may play in the management of COVID-19.
Sponsors of devices under review by the TGA
Displaying 1 - 31 of 31
ARTG number: 334542
Sponsor: Allsafe Medical Pty Ltd
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Model/Type of use: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Test reports
Regulatory and other action
- Review Complete - Changes made to Instruction for use
ARTG number: 334650
Sponsor: AM Diagnostics
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Model/Type of use: 2019-nCoV Ab Test (Colloidal Gold)
Regulatory and other action
- ARTG entry cancelled by the sponsor on 21 August 2020
ARTG number: 333342
Sponsor: AM Diagnostics
Manufacturer: Hangzhou Alltest Biotech Co Ltd (China)
Model/Type of use: 2019-nCOV IgG/IgM Rapid Test Cassette
Test reports
Regulatory and other action
- Review complete - Changes made to Instructions for Use
ARTG number: 333299
Sponsor: Amandla China Pty Limited
Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Cassette
Test reports
Regulatory and other action
- Review Complete -Â Changes made to Instructions for use
ARTG number: 333341
Sponsor: APAC Security Pty Ltd
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Cassette
Test reports
Regulatory and other action
- Review complete - Changes made to Instructions for Use
ARTG number: 341411
Sponsor: Atomo Diagnostics Limited
Manufacturer: Atomo Diagnostics Limited (Australia)
Model/Type of use: AtomoRapid™ COVID-19 IgM/IgG Antibody Test
Test reports
Regulatory and other action
- Review complete - Conditions of Inclusion imposed
ARTG number: 333343
Sponsor: Ausliance Group Pty Ltd
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Cassette
Regulatory and other action
- ARTG entry cancelled by the sponsor on 31 July 2020
ARTG number: 335346
Sponsor: Biovent Consulting Pty Ltd
Manufacturer: GenBody Inc (Korea - Republic of)
Model/Type of use: GenBody COVID-19 IgM/IgG
Test reports
Regulatory and other action
- ARTG entry cancelled by the sponsor on 24 August 2020
ARTG number: 347730
Sponsor: Cartex Hoya Pty Ltd
Manufacturer: Xiamen Biotime Biotechnology Co Ltd (China)
Model/Type of use: Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Test reports
Regulatory and other action
- Review complete
ARTG number: 333880
Sponsor: CK Surgitech Pty Ltd
Manufacturer: Qingdao Hightop Biotech Co Ltd (China)
Model/Type of use: SARS-CoV-2 IgM/lgG Antibody Rapid Test
Regulatory and other action
- ARTG entry cancelled by the sponsor on 29 May 2020
ARTG number: 333882
Sponsor: Complementary Medicines Group Pty Ltd
Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)
Model/Type of use: LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Test reports
Regulatory and other action
- Review Complete - Changes made to Instruction for use
ARTG number: 333882
Sponsor: Complementary Medicines Group Pty Ltd
Manufacturer: Hangzhou Laihe Biotech Co Ltd (China)
Model/Type of use: LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)
Test reports
Regulatory and other action
- Review Complete - Changes made to Instruction for use
ARTG number: 335830
Sponsor: Emergence Technology Pty Ltd
Manufacturer: Zhuhai Livzon Diagnostics Inc (China)
Model/Type of use: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
Test reports
Regulatory and other action
- ARTG entry cancelled by the sponsor on 29 October 2020
ARTG number: 333884
Sponsor: Endo X
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Model/Type of use: 2019-nCoV Ab Test (Colloidal Gold)
Regulatory and other action
- ARTG entry cancelled by the sponsor on 11 May 2020
ARTG number: 335597
Sponsor: Haemokinesis Pty Ltd
Manufacturer: PCL Inc (Korea - Republic of)
Model/Type of use: PCL COVID19 IgG/IgM Rapid Gold
Test reports
Regulatory and other action
- Decision of device cancellation revoked pending further testing of the device by a Delegate of the Secretary.
ARTG number: 337071
Sponsor: Healtheguru Pty Ltd
Manufacturer: NTBIO Diagnostics Inc (Canada)
Model/Type of use: One Step Rapid Test - COVID-19 IgG/IgM Antibody Test
Test reports
Regulatory and other action
- Review complete
ARTG number: 336146
Sponsor: Innovation Scientific Pty Ltd
Manufacturer: Innovation Scientific Pty Ltd (Australia)
Model/Type of use: InnoScreen™ COVID-19 IgG/IgM Rapid Test
Test reports
Regulatory and other action
- Review complete
ARTG number: 334506
Sponsor: Laser Corporation Holdings Pty Limited
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Model/Type of use: 2019-nCov Ab Test (Colloidal Gold)
Regulatory and other action
- ARTG entry cancelled by the sponsor on 7 July 2020
ARTG number: 343116
Sponsor: LJCJ Pty Ltd
Manufacturer: Zhongshan Chuangyi Biochemical Engineering Co Ltd (China)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Kit
Test reports
Regulatory and other action
- Review complete
ARTG number: 334982
Sponsor: Marcel Equity Pty Limited/Avania PL
Manufacturer: Zhuhai Livzon Diagnostics Inc (China)
Model/Type of use: Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Lateral Flow)
Test reports
Regulatory and other action
- ARTG entry cancelled by sponsor on 6 October 2020
ARTG number: 332961
Sponsor: MD Solutions Australasia Pty Ltd
Manufacturer: CTK Biotech Inc (USA)
Model/Type of use: Aria COVID-19 IgG/IgM Rapid Test
Test reports
Regulatory and other action
- Review complete - Changes made to Instructions for Use
ARTG number: 333303
Sponsor: Medicision Pty Ltd
Manufacturer: Cellex Inc (United States Of America)
Model/Type of use: Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test kit (lateral Flow Chromatographic Immunoassay)
Test reports
Regulatory and other action
- Review complete - Changes made to Instruction for use
ARTG number: 333344
Sponsor: Medsupply Australia Pty Ltd
Manufacturer: Hangzhou Biotest Biotech Co Ltd (China)
Model/Type of use: COVID-19 lgG/IgM Rapid Test Cassette
Test reports
Regulatory and other action
- Review complete
ARTG number: 334505
Sponsor: Onsite Diagnostics Pty Ltd
Manufacturer: Zhejiang Orient Gene Biotech Co Ltd (China)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Cassette
Test reports
Regulatory and other action
- Review complete - Changes made to Instruction for use
ARTG number: 334501
Sponsor: Solasta Life Pty Ltd
Manufacturer: Hangzhou Realy Tech Co Ltd (China)
Model/Type of use: 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device
Test reports
Regulatory and other action
- Review complete - Changes made to Instructions for Use
ARTG number: 335351
Sponsor: Southwind International Pty Ltd
Manufacturer: Healgen Scientific Limited Liability Company (United States Of America)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Test reports
Regulatory and other action
- Review complete
ARTG number: 333909
Sponsor: Stonestar Wholesale Pty Ltd
Manufacturer: VivaChek Biotech (Hangzhou) Co Ltd (China)
Model/Type of use: VivaDiagTM COVID-19 IgM/IgG Rapid Test
ARTG number: 333149
Sponsor: Suretest (formerly Life Clinic Australia Pty Ltd)
Manufacturer: Beijing Wantai Biologicalpharmacy Enterprise Co Ltd (China)
Model/Type of use: Wantai SARS-CoV-2 Ab Rapid Test kit
Test reports
Regulatory and other action
- Review complete - Changes made to Instruction for use
- Packaging updated to include sponsor information
ARTG number: 333902
Sponsor: Tayler Dental Consulting Pty Ltd - Agent Right Time Business Pty Ltd
Manufacturer: Guangzhou Wondfo Biotech Co Ltd (China)
Model/Type of use: SARS-CoV-2 Antibody Test (Lateral Flow Method)
Test reports
Regulatory and other action
- Review complete - Changes made to Instruction for use
ARTG number: 334060
Sponsor: TrendBio Pty Ltd
Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)
Model/Type of use: 2019-nCoV Ab Test (Colloidal Gold)
Regulatory and other action
- ARTG entry cancelled by the sponsor on 21 August 2020
ARTG number: 333881
Sponsor: Zenpharm Pty Ltd
Manufacturer: Hangzhou Clongene Biotech Co Ltd (China)
Model/Type of use: COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P)-ICOV4212
Regulatory and other action
- Cancelled by the Secretary on 23 June 2020