Date of publication: October 15, 2020

Objectives:

To determine the performance standards used by other regulatory agencies for approval of COVID-19 rapid antigen tests for market entry
To determine the validation testing requirements of regulatory agencies for COVID-19 rapid antigen tests
To determine the accuracy of rapid antigen tests either alone or as an adjunct to RT-PCR in the diagnosis of COVID-19 as compared to RT-PCR alone
To synthesize information on implemented testing strategies using rapid antigen tests for diagnosing COVID-19 in different countries
To synthesize information on existing positions/recommendations of HTA agencies on the use of rapid antigen tests for diagnosing COVID-19
To determine the resource requirements needed to implement use of rapid antigen tests for COVID-19 diagnosis

HTAC Recommendation Review: