- FDA has authorized an additional three over-the-counter COVID-19 antigen home tests for single use in people with symptoms.
- Two of the manufacturers, Access Bio and Becton Dickinson, already had emergency use authorization for use as a serial test. The reissue of the EUAs clears Access Bio and BD to provide their kits as one-off tests in people with COVID-19 symptoms.
- The third manufacturer, InBios International, received an EUA for a new test in similar patient populations, with FDA permitting use of SCoV-2 Ag Detect Rapid Self-Test as a single test in people with COVID-19 symptoms but requiring serial testing in asymptomatic individuals.
It is now almost two months since FDA redefined the scope of rapid antigen testing by authorizing Acon's Flowflex COVID-19 Home Test as a one-time test of people with and without symptoms. The EUA authorized the rapid coronavirus antigen kit as a one-time test of asymptomatic people, ending the need for the serial testing required when using many other kits.
The latest set of EUAs expands the pool of kits eligible for use as single tests of people with symptoms but has no effect on the availability of one-time assessments of asymptomatic individuals. While the Acon EUA permits use of the rapid antigen kit as a single test of people "without symptoms or other epidemiological reasons to suspect COVID-19 infection," the three new and reissued authorizations all stipulate that the test must be done twice over three days in asymptomatic individuals.
Even so, the EUAs still further the emergence of rapid antigen kits as an alternative to PCR tests in people with COVID-19 symptoms. Previously, Access Bio and BD were authorized to provide their kits "as a serial test without a prescription by people with or without symptoms." The reissued EUAs add "a single test for people with COVID-19 symptoms" to the lists of uses of the kits.
InBios also received an EUA for its test for use as a serial test for people without symptoms and as a single test for people with COVID-19 symptoms. The only difference to InBios' indication is its EUA stipulates testing should happen within five days of symptom onset, whereas no time frame is given for the Access Bio and BD products.
Access Bio's CareStart COVID-19 Antigen test gives results within 10 minutes, BD's Veritor within 15 minutes and InBios' SCoV-2 Ag Detect within 20 minutes.
The release of the EUAs comes shortly after FDA updated its template for developers of molecular and antigen diagnostic COVID-19 tests for home use. The updated text is nearly identical to the version FDA published late last month, with changes limited to the deletion of a line about running usability studies. Previously, FDA recommended giving participants in usability studies a mock result to interpret.