The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the SPERA COVID-19 Ag Test from Xtrava Health.
Authorized for use at the point of care, the rapid lateral flow immunoassay directly detects the COVID-19 causing virus in shallow nasal samples and provides results within 15 minutes. The test is authorized for use in congregate settings such as schools, nursing homes, workplaces, and physician offices.
“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,” says 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.”
According to the company, the easy-to-use test requires only shallow nasal swabs, and, in the presence of the virus, a line is clearly visible to the eye within 15 minutes. The SPERA COVID-19 Ag Test provides 92% sensitivity (the true positive rate) and 97% specificity (the true negative rate). 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.
“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,” says Iman Sadreddin, Xtrava Health’s chief operating officer.
Xtrava Health was awarded a $6.2 million contract by the NIH under the Rapid Acceleration of Diagnostics (RADxSM) initiative to expedite the launch of its SPERA COVID-19 antigen test. This project was funded in part by the NIH RADxSM initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00002.
For more information, visit Xtrava Health.