December 18, 2020 – Intrivo Diagnostics (Los Angeles, CA) announced it will begin national distribution and commercialization of diagnostic testing products developed by Access Bio, Inc. (Somerset, NJ), a testing manufacturer, through Concordance Healthcare Solutions (Tiffin, OH) and NDC, Inc. (Nashville, TN).
As Access Bio’s exclusive U.S. commercialization partner, Intrivo’s new channel agreements will expand the supply chain for the CareStart line of COVID-19 testing products across the country. To date, Access Bio has received FDA Emergency Use Authorization (EUA) for its RT-PCR test, IgM/IgG antibody test and most recently, a rapid point-of-care (POC) antigen test.
The CareStart COVID-19 antigen test is a lateral-flow immunochromatographic assay capable of producing results within 10 minutes of being administered with 88.4% sensitivity and 100% specificity. The test is a self-contained, single-use product designed to detect extracted nucleocapsid protein antigens specific to SARS-CoV-2 in nasopharyngeal specimens collected from individuals suspected of being infected with COVID-19 or exposed to COVID-19.
The assay includes a swab, a vial of extraction solution and a cassette the size of a small flash drive. A positive test result is indicated by a visible line in the cassette and doesn’t require any special technical training to use, the company says.
Each kit can administer up to 20 antigen tests.