Nirmidas is the first US company to receive an FDA EUA for a Covid-19 point-of-care fingerstick antibody test. Credit: soula walid / Unsplash.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.