The US Food and Drug Administration in a new report warns people against using the rapid COVID-19 test from the California-based Innova Medical Group, the Guardian reports. The test, it notes, forms the basis of the mass testing program in the UK.
The test, a lateral flow immunochromatographic assay, is designed to quickly detect viral nucleocapsid protein antigens from nasal swab samples and the company says it has 97.0 percent sensitivity and 99.9 percent specificity in detecting infected individuals, according to 360Dx. But, it adds, the FDA says the test may not perform as thought. "The FDA has significant concerns that the performance of the test has not been adequately established, presenting a risk to health," the agency says in a statement.
Additionally, the FDA says the company was selling the test in the US despite not having marketing approval, clearance, or authorization and tells healthcare providers and others to return their tests to the company or destroy them. Innova tells 360Dx that it issued a voluntary recall of certain lots of the test in April, that the FDA noted that it had taken some corrective actions, and that "none of the inspectional observations concern the performance of the test."
The Guardian notes that the tests have also faced criticism in the UK about their accuracy and ability to detect lower viral loads. It adds that the UK's Medicines and Healthcare products Regulatory Agency is scheduled to review its special authorization of the test later this month.