NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for an at-home sample collection kit for SARS-CoV-2 molecular testing developed by nonprofit digital health firm Audere.
The [email protected] kit is designed for the self-collection of anterior nasal swab specimens by individuals aged 16 and older, as well as the collection of samples by adults in individuals aged 2 and older. Samples can be transported at ambient temperatures for in vitro diagnostic SARS-CoV-2 RNA testing.
Testing of [email protected] samples is limited to Audere-designated labs that are CLIA-certified to perform high-complexity tests, according to the FDA.
In addition to the sample collection kit, Seattle-based Audere has developed a COVID-19 symptom tracking and surveillance tool that is currently used by a local fire department.