FDA authorizes fingerstick COVID-19 antibody test

Nirmidas Biotech announced this week that it received FDA emergency use authorization (EUA) for its COVID-19 test in point-of-care settings.

Palo Alto, Calif-based Nirmidas Biotech’s MidaSpot rapid COVID-19 antibody combo detection kit uses fingerstick serology testing to detect IgG/IgM antibodies related to the SARS-CoV-2 virus causing COVID-19, according to a news release.

MidaSpot, touted by Nirmidas as the first point-of-care fingerstick COVID-19 test to receive EUA, can now be administered widely in CLIA-waived settings (such as doctor’s offices, urgent care facilities, ERs, pharmacies and more) with results yielded in 15-20 minutes.

In point-of-care testing, the test detects and differentiates antibody IgG and IgM post-COVID-19 infection. MidaSpot demonstrated 100% sensitivity for IgG after 14 days post-symptom onset and 100% sensitivity for IgM after seven days post-symptom onset in clinical studies.

Nirmidas previously deployed…

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