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Access Bio Gets FDA Emergency Use Authorization for Point-of-Care, SARS-CoV-2 Immunoassay

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization to Access Bio for a point-of-care version of its SARS-CoV-2 antibody assay.

The CareStart EZ COVID-19 IgM/IgG is designed to detect and differentiate immunoglobulin M and G against SARS-CoV-2 in serum, plasma, venous whole blood, and fingerstick whole blood when used by labs CLIA-certified to perform moderate- or high-complexity tests. Results are provided in 15 minutes.

The lateral flow immunoassay is also authorized for use with fingerstick whole blood at point-of-care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation, according to the FDA.

About a year ago, Somerset, New Jersey-based Access Bio received EUA from the FDA for its CareStart COVID-19 IgM/IgG SARS-CoV-2 test, which is only authorized for use with serum, plasma, and venous whole blood.