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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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Publication date: 
29 April 2020
Last updated: 
14 May 2020
Publication type: 
Report
Intended audience: 
Health sector
Description: 

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.