Troubles continue for one of the country’s leading producers of rapid COVID-19 diagnostics. In September, the US Food and Drug Administration posted an alert to its website warning testing labs of the potential for false positive tests from a pair of molecular SARS-CoV-2 detection kits from Abbott Laboratories—the Alinity m SARS CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP. A month later, FDA upped the ante by issuing a Class I recall for the products. Here’s a quick briefing on the situation. The Abbott Alinity m Assays As society continues to emerge from lockdown, demand has grown for high throughput testing for use in widespread COVID-19 screening. While offering scalability and speed, questions remain about whether high throughput COVID-19 tests are accurate enough to provide a reliable screening solution. Abbott has been among the leaders in developing tests to meet the demand for high throughput COVID-19 test products. The Alinity m SARS-CoV-2 kit is a real-time reverse transcription (RT) polymerase chain reaction (PCR) for qualitative detection of nucleic acid from the virus, received Emergency Use Authorization (EUA) from the FDA in May 2020 and has been granted multiple revisions, including for use on asymptomatic screening and in pooled samples. In December, […]