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FDA Grants EUAs for SARS-CoV-2 Tests From Thermo Fisher Scientific, Phase Scientific International

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test from Thermo Fisher Scientific and a point-of-care antigen test for the virus from Phase Scientific International.

Thermo Fisher's TaqPath COVID-19 Fast PCR Combo Kit 2.0 is designed to detect SARS-CoV-2 nucleic acid in saliva samples collected without preservatives by a healthcare provider. It is authorized for use by any lab CLIA-certified to perform high-complexity tests.

The test, which received CE marking in June, uses eight targets across three genomic regions to ensure accurate detection even with SARS-CoV-2 variants, according to Carlsbad, California-based Thermo Fisher.

Phase's Indicaid COVID-19 Rapid Antigen Test is a lateral flow immunoassay designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from potentially infected individuals within five days of symptom onset. Samples may be collected by a healthcare provider or self-collected under supervision.

According to Hong Kong-based Phase, the test provides results within 20 minutes. It may be used by any lab CLIA-certified to perform moderate-, high-, or waived-complexity tests. It is also authorized for use in point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, according to the FDA.

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