Premier Medical will submit an application seeking Emergency Use Authorization (EUA) for its Sure Status COVID-19 Antigen Card Test from the US Food and Drug Administration (FDA) for distribution and use in the country.
The rapid chromatographic immunoassay is for the qualitative detection of antigens specific to SARS-CoV-2 in human nasopharynx.
The World Health Organization (WHO) has included the rapid test in its worldwide Emergency Use Listing.
Premier Medical noted that it is the third company in the world and the only Indian-based company to achieve the listing.
Performed by taking a sample from the nose, the simple and affordable test can aid in detecting viral genetic material within the sample
The test is based on colloidal gold immunochromatography and offers results in roughly 15 minutes.
With 100% specificity and 94.5% sensitivity, the assay can aid in testing people rapidly and conveniently in various settings, including schools, offices and doctor’s clinics, without requiring any extra equipment.
The test is developed and manufactured completely in India and will be distributed from Somerset, New Jersey, US, by Premier Medical USA.
The company is also developing a test for the detection of other Covid-19 variants based on its patented platform technology and rapid saliva testing, which would help to bring the virus and its transmission under control.
Premier Medical is focused on developing, manufacturing and distributing diagnostic testing for infectious diseases, such as human immunodeficiency virus (HIV), Malaria, Hepatitis and Syphilis.
Furthermore, it has partnered with the Centers for Disease Control and universities to develop novel tests for different infectious diseases.