NEW YORK ─ The US Food and Drug Administration on Monday issued a warning letter to clinical laboratory staff and healthcare providers to alert them about an increased risk of false-positive results from Becton Dickinson's BD SARS-CoV-2 reagents for its BD Max System test.
The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from tests using the BD SARS-CoV-2 reagents for the BD Max System, consider confirming the result with an alternate authorized test, and report any issues with using COVID-19 tests.
In one study, a manufacturer found approximately 3 percent of results were false positives, the FDA said.
BD SARS-CoV-2 reagents for the BD Max System test are authorized for use in US labs that are certified under CLIA to perform moderate- and high-complexity tests. The test detects viral nucleic acid from SARS-CoV-2 in upper respiratory specimens, such as nasal swabs.
Franklin Lakes, New Jersey-based Becton Dickinson received an Emergency Use Authorization for the test in April.
According to Troy Kirkpatrick, a BD spokesperson, the company has received reports of potential false-positive results from certain customers using the BD SARS-CoV-2 reagents for the BD Max System. "These users represent a small subset of the overall true-positive results," he said in an email. "As part of our efforts to continuously improve our assays, we approached FDA and communicated options available to further improve the performance of the BD SARS-CoV-2 [test]. We are currently discussing these options with FDA, including the information and data required to support these changes."
The FDA said it is working with Becton Dickinson to resolve the issue associated with false-positive results, and that it will continue to keep clinical laboratory staff, healthcare providers, manufacturers, and the public informed of new or additional information.