The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Nirmidas Biotech’s Covid-19 rapid antibody IgG/IgM test for use in point-of-care (POC) settings.
Using a fingerstick serology test, the MidaSpot COVID-19 Antibody Combo Detection Kit checks for antibodies against the RBD antigen, which is present on the SARS-CoV-2 virus surface.
With the development, Nirmidas became the first US company to receive an FDA EUA for a Covid-19 point-of-care fingerstick antibody test.
The simple and efficient test does not require instrument, delivers results in 15 to 20 minutes, and can identify and differentiate antibody IgG and IgM after Covid-19 infection in POC testing.
The kit can now be used in CLIA-waived settings for POC testing such as doctor’s offices, urgent cares, and nursing homes.
In clinical trials on Covid-19 patients, the MidaSpot Antibody POC test demonstrated 100% sensitivity for IgG after 14 days on developing symptoms and 100% sensitivity for IgM after seven days of symptom onset.
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Furthermore, it can help to make quick decisions in POC settings to detect people with recent or prior infection and to carry out population surveillance for communities and organisations to help in guiding resource deployments.
Earlier, the rapid test was granted EUA for high and moderate complexity laboratories only.
Nirmidas Biotech co-founder and CEO Dr 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.”
With the onset of Covid-19 pandemic, the company had launched a total of three Covid-19 tests.