NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for BioSynchronicity's point-of-care C-Sync COVID-19 Antigen Test.
The lateral flow immunoassay is designed to detect SARS-CoV-2 nucleocapsid and spike protein antigens in direct anterior nasal swab specimens. It is authorized for use with symptomatic individuals when testing occurs at least twice over three days with at least 48 hours between tests, as well as with asymptomatic individuals when testing occurs at least three times over five days with at least 48 hours between tests, according to the FDA.
Use of the test is limited to laboratories CLIA-certified to perform moderate-, high-, or waived-complexity tests. The test is also authorized for use at the point of care in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.