DiaSorin Gets 510(k) Clearance for Simplexa COVID-19 Test
Saluggia, Italy-based DiaSorin received 510(k) Clearance from the FDA for its Simplexa COVID-19 Direct Kit.
The kit provides a sample-to-answer PCR assay for the detection of SARS-CoV-2 and variants of concern using nasopharyngeal or nasal swab specimens, enabling a result in about an hour.
The test uses fluorescent probes and corresponding forward and reverse primers to amplify SARS-CoV-2 viral RNA, targeting two different regions of the SARS-CoV-2 genome while an RNA internal control is used to detect RT-PCR failure and/or inhibition, said the company.
The test is designed for use with the company’s Liaison MDX system, DiaSorin said.
The development of the product was funded by the Department of Health and Human Services’ Administration for Strategic Preparedness and Response as well as the Biomedical Advanced Research and Development Authority.