Date of publication: April 30, 2021


  • 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

Evidence Summary:


HTAC Recommendation Review: