Coronavirus company news summary - FDA grants EUA for Xtrava Health’s rapid Covid-19 antigen test - US faces shortage of rapid Covid-19 antigen tests - Verdict Medical Devices
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Coronavirus company news summary – FDA grants EUA for Xtrava Health’s rapid Covid-19 antigen test – US faces shortage of rapid Covid-19 antigen tests

22 Oct 2021

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Xtrava Health’s SPERA COVID-19 Ag Test for use in point-of-care settings. The rapid lateral flow immunoassay can identify the SARS-CoV-2 virus in shallow nasal samples to deliver results in 15 minutes. With a sensitivity and specificity of 92% and 97% respectively, the test demonstrated the ability to identify all key variants of the virus, including the Delta, Lambda, and Mu.

The US is facing a shortage of rapid Covid-19 antigen tests due to a rise in demand from users and businesses ahead of the country’s vaccine mandate deadline for workers on 22 November this year. As per the mandate, workers should either submit proof for vaccination or perform weekly testing, the Financial Times reports. Limitations have been placed by pharmacy chains on customer purchases while some test providers have informed certain companies that they would be unable to deliver more kits ahead of this deadline.

Medikabazaar has entered an exclusive partnership to supply Korean company Boditech Med’s in-vitro diagnostic solutions across India. As part of the collaboration, Medikabazaar will distribute Boditech’s automated desktop analysers such as the AFIAS 1 and AFIAS 6 immunoassay analysers together with a variety of diagnostic kits and reagents, EH News Bureau reports. These will offer Covid-19 diagnostics as well as diagnostic solutions for cancer, cardiac, diabetes, hormonal and other diseases including dengue, rota and adenovirus.