NEW YORK ─ Hauppauge, New York-based Chembio Diagnostics said on Friday that it has started distribution of the InBios International SCoV-2 Ag Detect Rapid Test, which received US Food and Drug Administration Emergency Use Authorization in May.
Financial and other terms of the distribution agreement were not disclosed.
The SCoV-2 Ag Detect Rapid Test, authorized for use in laboratories with a CLIA-waiver, provides results in 20 minutes from a nasal swab and requires no instrumentation. It can be used to test patients suspected of having COVID-19 by their healthcare provider within five days of symptom onset and for asymptomatic serial testing, Chembio said.
Used in decentralized and traditional testing settings, the rapid antigen test is ready for shipment to its customers in the US, the firm added.
Charles Caso, vice president of sales and marketing for Chembio, said in a statement that it is also distributing Status COVID-19/Flu A&B, which differentiates flu from COVID-19 using a nasal swab.
Monmouth Junction, New Jersey-based Princeton BioMeditech's Status COVID-19/Flu A&B test is designed for the detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A, and influenza B. It received FDA EUA in February.