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FDA Grants Emergency Use Authorization to Xtrava Health SARS-CoV-2 Point-of-Care Antigen Test

NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization to Xtrava Health's SPERA COVID-19 Ag Test for SARS-CoV-2.

The lateral flow immunoassay is designed for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swabs collected by a healthcare provider within five days of the onset of a patient's symptoms.

The assay may be used by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests. It may also be used at the point of care in settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Earlier this year, Santa Clara, California-based Xtrava received funding from the National Institutes of Health's Rapid Acceleration of Diagnostics Tech, or RADx Tech, initiative to develop a SARS-CoV-2 antigen test.