The FDA warned that there is an increased risk for a false-positive result using BD SARS-CoV-2 Reagents for the BD Max System test. 

In one study, the manufacturer found approximately 3% of results were false-positive results. The FDA recommends that clinical laboratory staff and health care providers:

  • 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; and 
  • report any issues with using COVID-19 tests to the FDA. See reporting problems to the FDA below.

The BD SARS-CoV-2 Reagents for BD Max System test is only authorized for use in laboratories in the Unit-ed States certified under the Clinical Laboratory Improvement Amendments of 1988 (known as CLIA) to perform moderate- and high-complexity tests. The test is designed to detect viral nucleic acid from the virus that causes COVID-19 in upper respiratory specimens, such as nasal swabs. This letter only applies to the BD SARS-CoV-2 Reagents for the BD Max System.The test, which provides qualitative detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swab samples, received an  emergency use authorization on April 8. 

The FDA said it is working with BD to resolve this issue. 

The agency encouraged health care providers to report any adverse events or suspected adverse events experienced with tests using the BD SARS-CoV-2 Reagents for the BD Max System.

—Clinical Oncology News Staff