The FDA authorisation allows the easy administration of serology test in point-of-care settings, which delivers results in 15-20 minutes
Nirmidas Biotech has secured the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its Covid-19 rapid antibody IgG/IgM test.
The Covid-19 rapid antibody IgG/IgM test, dubbed MidaSpot Covid-19 Antibody Combo Detection Kit, is indicated for use in point-of-care (POC) settings.
It leverages a fingerstick serology test to detect the antibodies against RBD antigen, found on the surface of the SARS-CoV-2 virus.
Nirmidas is a member of the StartX Med Covid-19 Task Force, and is the first US company to receive FDA EUA for a Covid-19 point-of-care fingerstick antibody test.
Nirmidas Biotech co-founder and CEO Meijie Tang said: “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’ Covid-19 detection kit delivers results in 15 to 20 minutes
The MidaSpot Covid-19 Antibody Combo Detection Kit has been designed to support the administration in CLIA-waived settings for point-of-care testing, including doctor’s offices, urgent cares, pharmacies, nursing home facilities, and testing sites.
The company said that its high-performance test is easy to use, does not require any instrument is needed, and delivers results within 15 to 20 minutes.
Also, the test facilitates rapid identification of individuals with recent or prior infection in POC settings, and help perform population surveillance for communities and organisations to help guide resource deployments.
In the clinical studies of Covid-19 patients with fingerstick whole blood, MidaSpot Antibody POC test demonstrated 100% sensitivity for IgG, 14 days after the onset of symptoms, and 100% sensitivity for IgM, 7 days after the onset of symptoms.
Nirmidas said that its previous Covid-19 rapid antibody test has been deployed in over more than ten states in the US and several US military bases.
Furthermore, the company is currently developing a third Covid-19 test for home-collection saliva antibody detection, based on a nanotechnology platform pGOLD high accuracy assay.