The Sichuan CDC where ran patient OP/NP swabs on RT-PCR (Da An Gene Co Ltd) and simultaneously on the AFS-1000 analyser with the SARS-C0V-2 cassette.

The clinical samples were across a wide range of Ct values and the study shows the Ct values for N and ORF1ab regions as well as the reading on the analyser for each test subject (the machine is designed to give a qualitative ‘positive/negative’ response but the results are semi-quantitative and can be downloaded).

In these clinical trials of 157 PCR-confirmed positives and 209 PCR-confirmed negatives, the AFS-1000 with the COVID-19 test cassette was 100% concordant with PCR positive results with Ct values ≤39. People are not infectious at Ct>34.