FIND evaluation of SARS-CoV-2 antigen (Ag) detecting tests

SARS-CoV-2 antigens are shed as the virus replicates during active infection, and thus their detection can be used to diagnose current infection.

FIND is conducting prospective diagnostic evaluation studies in collaboration with multiple, independent sites to determine the accuracy of COVID-19 Ag RDTs.

Suppliers interested in having their tests considered for inclusion in these independent evaluation studies may submit their information via our technology scouting submission form. (Please select ‘Outbreak’ as the ‘Disease Area’ and ‘SARS-CoV-2 Ag evaluation’ as the ‘Disease Area Subtype’ on the form and upload the completed submission template and instructions for use.)

All test submissions are scored according to:
—their regulatory status and time to market;
—the manufacturing and distribution capacity of the supplier; and
—the supplier-reported clinical and analytical performance (target ≥ 80% sensitivity and ≥ 97% specificity).

Below is a list of all tests that have been selected to date and the status of the evaluation (please note: list is updated on a routine basis).

Participants in the Ag RDT evaluation studies include individuals presumed to have COVID-19 due to the presence of symptoms or with close contact with a confirmed case, but may not capture the full spectrum of disease; therefore, sensitivity and specificity estimates may not be indicative of the real-world performance of these tests in all intended use settings. Interim analyses are performed at 25% and 50% enrolment, and the evaluation is stopped if tests do not meet 97% specificity.

Antigen RDT evaluation protocol summary

More information

For questions relating to the evaluation of immunoassays, please contact our Emerging Threats team.