On July 6, the U.S. Food and Drug Administration (FDA) issued a warning letter alerting clinical laboratory staff and providers of the increased risk of false-positive results from Becton Dickinson (BD) BD SARS-CoV-2 reagents for its BD Max System test.

The Warning Letter

If you are currently using the reagents for the BD Max System and get a positive result, the FDA recommends that you treat the result as presumptive and consider confirming it with another authorized test. The warning letter also calls on laboratory staff and providers to report any issues with using COVID-19 tests.

The FDA granted Emergency Use Authorization (EUA) for the BD PCR-based SARS-CoV-2 kit on April 8. The test, which detects viral nucleic acid from SARS-CoV-2 in upper respiratory specimens, was cleared for moderate- and high-complexity testing laboratories on the BD Max System using BD reagents. However, the company began receiving reports of the potential for false positives when the test was used with the reagents, including one study in which a manufacturer found that approximately 3 percent of results were false positives.

Even though the users citing accuracy concerns represented a small subset of overall true-positive results, the firm approached the FDA to discuss the problems and go over the options to improve test performance, according to a BD spokesperson. The FDA is currently working with the firm to resolve the issue and promises to provide new or additional information as the situation develops.

Takeaway

Accuracy and the risk of false positives generated by EUA COVID-19 serology tests has been an ongoing concern. However, the BD test is a molecular PCR-based assay which are generally considered more accurate and reliable than serology-based antibody tests. Even so, the BD situation seems to be a bit of an outlier limited to a particular PCR product using a particular reagent on a particular platform.

Here are some of the key new FDA EUAs and clearances announced in July: