Xtrava Health Receives Emergency Use Authorisation for COVID-19 Ag Test
pharmafile | October 22, 2021 | News story | Medical Communications |
The US FDA has issued an Emergency Use Authorisation (EUA) for Xtrava’s SPERA™ COVID-19 Ag Test.
The easy-to-use, rapid lateral flow immunoassay detects the COVID-19 causing virus in shallow nasal samples authorised for use at the point of care.
Xtrava is a Silicon Valley company, founded in 2014, focused on using unique technology and strategic partnerships to manufacture and commercialise diagnostic products for health professions and at-home use. Their COVID test has been authorised for use in places such as schools, nursing homes, workplaces, and doctor’s offices.
The main advantages of the test include that it delivers rapid results within 15 minutes, and that it has ease-of-use – the test only requires shallow nasal swabs. In the presence of the virus, a line is clearly visible to the eye within 15 minutes or less. The SPERA COVID-19 Ag Test provides 92% sensitivity and 97% specificity.
A study conducted by the National Institutes of Health (NIH), in collaboration with Emory University, Georgia Institute of Technology, and Children’s Healthcare of Atlanta confirmed that the test detects all major circulating variants, including the Delta, Lambda, and Mu.
“The rise in COVID-19 cases from emerging variants has increased the demand for accurate, rapid tests, especially among schools and workplaces that have mandated frequent testing,” said Sameh Sarhan, CEO of Xtrava Health.
“With the help of our top-tier Japanese partner Denka, we can now deliver millions of rapid antigen tests annually to the market, ensuring simple and accurate COVID-19 tests are more readily available to alleviate the shortage in tests.”
Iman Sadreddin, Xtrava Health’s COO, adds: “We have been working closely with our supply chain and logistics partners to ensure fast delivery of our high-quality tests, to meet the current market demand.”
Lina Adams
