False Positive Results With BD SARS-CoV-2 Reagents For The Bd Max System
October 1, 2020,
The National Agency for Food and Drug Administration and Control has received information from the US FDA on an increased risk of a false positive result with BD SARS-CoV-2 Reagents for the BD Max System test. In one study, the manufacturer found approximately three percent (3%) of results were false positive results.
The BD SARS-CoV-2 Reagents for BD Max System test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. This warning only applies to the BD SARS-CoV-2 Reagents for the BD Max System.
Healthcare providers should;
- Consider any positive result presumptive from tests using the BD SARS-CoV-2 Reagents for the BD Max System. Consider confirming with an alternate authorized test.
- Report any issues with using COVID-19 tests to NAFDAC
Healthcare professionals are encouraged to 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, NAFDAC PRASCOR (20543 TOLL FREE from all networks) or via email@example.com