Post-market validation of three serological assays for COVID-19 – final report
The Doherty Institute has evaluated 2 serology-based point of care tests.
The evaluation is part of a review of these tests by the Therapeutic Goods Administration (TGA).
These findings will inform the need for TGA to undertake any post-market action.
This could include changes to the instructions for use to include more information about the limitations of the tests.
Further information is on the TGA’s website, post-market evaluation of serology-based point of care tests.
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This report presents the results of post-market validation of serological assays for the detection of SARS-CoV-2 antibodies.
It finds that serological assays have limited, if any, role in the diagnosis of acute COVID-19 infection.
This is in keeping with recent position statements by the Public Health Laboratory Network and the Royal College of Pathologists Australasia.