Australia’s TGA Re-Tests COVID-19 Antibody Tests

As part of a postmarket review, Australia’s Therapeutic Goods Administration (TGA) is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies.

The agency is requesting that all point-of-care test sponsors provide information on the clinical studies undertaken to support the performance claims for their devices.

The TGA tested two point-of-care tests, the Onsite IgM/IgG Rapid Test manufactured by California-based CTK Biotech and the VivaDiag COVID-19 IgM/IgG rapid test manufactured by VivaChek Biotech in Hangzhou, China.

Results of both tests showed that the sponsors claimed higher sensitivity than could be confirmed by researchers at the Doherty Institute, a joint venture between the University of Melbourne and the Royal Melbourne Hospital.

For example, CTK Biotech claimed its test had a sensitivity of 96.86 percent for accurately identifying positive cases, while the sensitivity of the device when tested by the institute was 56.9 percent.

The sensitivity claimed by VivaChek Biotech was 81.25 percent between days four to 10 and 97.1 percent between days 11 to 24. But the institute’s testing found a sensitivity of 51.8 percent between days four and 10. For samples collected 20 days post onset of symptoms, the sensitivity improved to 78.8 percent.