NAFDAC Gives Update On False Positive Results With BD SARS-CoV-2 Reagents

The National Agency for Food and Drug Administration and Control (NAFDAC), has today informed the general public that information has reached them from the United States of America’ Food and Drug Administration on an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test.

According to NAFDAC, the manufacturer discovered that approximately 3% of results were false positive results.

The BD SARS-CoV-2 Reagents for BD Max System test is manufactured to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs.

However this warning applies only to the BD SARS-CoV-2 Reagents for the BD Max System.

NAFDAC thereby advised Healthcare providers to take note of any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System and also consider confirming with an alternate authorized test.

Healthcare Providers are therefore advised to report any issues with using COVID-19 tests to NAFDAC and report any adverse events or suspected adverse events experienced with tests using the BD SARS-CoV-2 Reagents for the BD Max System to the nearest NAFDAC office.