Post-market validation of point-of-care diagnostic kits (TGA approved)
Accurate identification of a COVID-19 infection based on serology results, particularly those obtained from tests used at the point-of-care (POC), requires a well-defined understanding of the antibody response profile. The Doherty Institute has been engaged by the Department of Health and Human Services (DHHS) to assist with the post-market verification process of these tests to inform their use for accurate identification of a COVID-19 infection. To date, the Doherty Institute has completed the validation of 15 serology based POC tests as part of a review by the Therapeutic Goods Administration.