https://www.tga.gov.au/post-market-evaluation-serology-based-point-care-testsSARS-CoV-2 Antibody Test (Lateral Flow Method) (Guangzhou Wondfo Biotech Co Ltd, China)
The overall total antibody sensitivity and specificity claimed by the manufacturer in the IFU provided with the device is 86.43% and 99.57% respectively (note this device does not distinguish between IgM and IgG results).
The overall total antibody sensitivity of the device when tested by the Doherty Institute was found to be 68.6% while the total antibody specificity was found to be 97.8%. For samples collected 14 days post onset of symptoms the overall sensitivity improved to 93.8%.
Post-market evaluation of serology-based point of care tests
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