The Doherty Institute in Melbourne has published a Report regarding the APAC COVID-19 Antibody test kit
The Doherty Institute, which is a joint venture between The University of Melbourne and The Royal Melbourne Hospital has published a report regarding the APAC COVID-19 Antibody test kit. As part of the TGA listing with the Federal Government, each supplier has to provide their test kits for evaluation, where the Doherty Institute compares the reported characteristics from the manufacturer with their own testing. The Doherty Institute finding was that the APAC COVID-19 antibody test kit “met, or where within the acceptable confidence interval for, the performance characteristics as reported by the manufacturer in the instructions for use (IFU)”.
The Doherty Institute used serum, sampled prior to the COVID-19 outbreak in Australia as well as on samples collected from patients with SARS-COV-2 infection confirmed by molecular testing. It is important to test the kit with serum before the outbreak in order to determine if the kit reacts to other Corona viruses and if so generate a false positive response to the specific SARS-COV-2 virus.
Naturally, it is equally important to test samples from patients with confirmed infection and more so when the IgM & IgG response appear.
As expected, the combined IgM/IgG response is limited during the first weeks post symptom onset and increase thereafter – sensitivity from all samples were 88.0%, while sensitivity post 14 days was 97.4%. Overall specificity was 98.0%.