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 its already authorized COVID-19 rapid antibody test in over 10 U.S. states and across multiple U.S. military bases, but for analysis in high and moderate complexity laboratories only. The company said it is “well-positioned” to increase production capacity and meet the demands at a low cost.
“As the world is deeply impacted by the outbreak and rapid spread of the SARS-CoV-2 virus, widely available rapid detection of antibodies is becoming indispensable as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, assessing population prevalence, and potential immunity,” Nirmidas co-founder & CEO Dr. Meijie Tang said in the release.