BD Covid Test Has Increased Risk of False Positives: FDA

The FDA said it’s alerting clinical laboratory staff and health care providers of an increased risk of false positives with BD SARS-CoV-2 Reagents for the BD Max System test.

• In one study, the manufacturer found about 3% of results were false positives, according to a statement on the agency’s website
• The FDA recommends that any positive result using the BD SARS-CoV-2 Reagents for the BD Max System should be considered presumptive

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Greg Chang in San Francisco at gchang1@bloomberg.net

To contact the editor responsible for this story:
Chakradhar Adusumilli at cadusumilli@bloomberg.net

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