FDA Warns Of False Negatives With Curative’s COVID-19 Test
If not used properly the test can mislead some patients that they do not have the coronavirus. The US FDA says health care providers should consider using another test if patients get a negative result.
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The agency is cautioning that current tests may give false negative results for patients with genetic mutations of SARS-CoV-2, making it harder to control the spread of the pandemic.
After criticism it was being too lax in overseeing COVID-19 antibody tests coming to market, the US agency issued an updated guidance earlier this month tightening regulations. As a result, it has now pulled more than two dozen tests that don’t meet its standards – and more are expected to follow.
The document from the Medical Device Innovation Consortium aggregates external data sources, various statistical methods and lays out other considerations for sponsors to help speed up and bolster a premarket product application to the US FDA.