FDA warns Covid-19 test is detecting false positive results

The US Food and Drug Administration (FDA) has alerted clinical laboratory staff and healthcare providers to the increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.

The test by Becton, Dickinson and Company (BD) received emergency use authorisation at the beginning of April. At this time, a study reportedly showed the test concurred with expected results 100% of the time.

However, within the FDA’s recent letter regarding the test, it states that the manufacturer found approximately three percent of results were false positive results in one study.

Recommendations from the FDA regarding this test include:

• Consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System. Consider confirming with an alternate authorised test.
• Report any issues with using Covid-19 tests to the FDA.

The FDA is currently working with BD to try and resolve this issue.