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Post market review of COVID-19 point-of-care tests

24 March 2021

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 - 32 of 32

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)

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

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

Regulatory and other action

  • Review Complete - 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

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

Regulatory and other action

  • Review complete - Conditions of Inclusion imposed

ARTG number: 333901

Sponsor: Aurora Future Education Group

Manufacturer: Innovita (Tangshan) Biological Technology Co Ltd (China)

Model/Type of use: 2019-nCoV Ab Test (Colloidal Gold) (IgM/IgG Whole Blood/Serum/Plasma Combo)

Regulatory and other action

  • Cancelled by Secretary on 16 October 2020

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

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

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)

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)

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)

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

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

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

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

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)

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

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)

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

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

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

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)

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

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)

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