Amazon subsidiary STS Lab Holdco received FDA emergency use authorization (EUA) for its real-time PCR test for COVID-19.
According to an FDA letter, dated March 25, the test is authorized for the detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individuals 18 or older, including those without symptoms or other reasons to suspect COVID-19 infection.
Samples can be collected with Amazon’s test kit either under the supervision of a healthcare provider or unsupervised at home, as well.
The authorization also extends to pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected with the Amazon COVID-19 collection kit under the supervision of a healthcare provider.
Testing with the Amazon collection kit is limited to certified laboratories that can perform high complexity tests and are designated by STS Lab Holdco. The kit includes a nasal swab, collection tube, biohazard bag and instructions for kit registration, sample collection and drop-off.