NEW YORK ─ The US Food and Drug Administration has granted separate Emergency Use Authorizations for SARS-CoV-2 assays developed by Amazon and Diabetomics.
The agency granted EUA to STS Lab Holdco, a subsidiary of Amazon.com, for the Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2. The test is authorized as a direct-to-consumer product for testing individual anterior nasal swab specimens self-collected at home using the Amazon COVID19 Test Collection Kit DTC. Any individual 18 years or older, including individuals without symptoms or other reasons to suspect COVID-19, can conduct testing.
The test is also authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to five individual anterior nasal swab specimens per pool that are collected in individual vials containing transport medium by any individual 18 years of age or older, including individuals without symptoms or other reasons to suspect COVID-19.
In March, Amazon had received EUA for its Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2. The test detects the ORF1ab gene of the virus in anterior nasal swab specimens self-collected using either the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider or the Amazon COVID-19 Test Collection Kit unsupervised at home.
Meanwhile, Hillsboro, Oregon-based Diabetomics nabbed an EUA for its CovAb SARS-CoV-2 Ab Test, which detects total antibodies, including IgG, IgA and IgM, to SARS-CoV-2 in human oral fluid. The test identifies individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, according to the FDA website. Samples should only be tested from individuals that are 15 days or more post-symptom onset, and emergency use of the test is limited to authorized laboratories.