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FDA Grants Emergency Use Authorization for Nirmidas Biotech Point-of-Care Coronavirus Antibody Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for a point-of-care SARS-CoV-2 antibody test developed by Nirmidas Biotech.

The MidaSpot COVID-19 Antibody Combo Detection Kit is a single-use, lateral flow immunoassay designed for the qualitative detection and differentiation of immunoglobulin M and G against SARS-CoV-2 in serum or plasma. It is also authorized for use with fingerstick whole-blood samples in a point-of-care setting.

The test is based on colloidal gold immunochromatography and provides results on a test card in about 20 minutes.

The test may be used with serum and plasma samples by any lab CLIA-certified to perform moderate- or high-complexity tests, or in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, according to the FDA.

In October, Palo Alto, California-based Nirmidas received FDA EUA for a SARS-CoV-2 antibody test that does not have point-of-care authorization.