FIND evaluations of SARS-CoV-2 Ag tests

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

From 2020 to 2023, FIND has been conducting prospective diagnostic evaluation studies in collaboration with multiple, independent sites to determine the accuracy of COVID-19 Ag rapid diagnostic tests (RDTs). The expression of interest (EOI) to participate in the Ag RDT evaluations is now closed and no further evaluations are projected.

Test submissions were selected through a scoring system taking into consideration:

• supplier-reported analytical performance
• supplier-reported clinical performance and size of the related study population/number of COVID-19 positive cases
• ease of use of the test (need for an instrument, sample type)
• manufacturing and distribution capacity (especially related to the ability of the company to access LMICs market)
• regulatory status – products with approval from stringent regulatory bodies such as FDA EUA or WHO EUL are scored higher than CE-IVD self-reported tests which are in turn scored higher than RUO tests.

Status of submission to WHO EUL or approval/failure of another COVID-19 test has also been considered for the final stage of selection.

Results of the evaluations are presented in Table 1. Last update: 27 March 2023

More information

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