Becton’s SARS-CoV-2 Reagents Pose False-Positive Risk: U.S. FDA

Becton Dickinson’s SARS-CoV-2 reagents for the BD Max System have an increased risk of false-positive results, the U.S. FDA said in a letter to clinical lab staff and heath-care providers.

• In one study, BD found ~3% of results were false positives
• Positive results should be considered presumptive and labs should consider confirming with an alternate authorized test

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