FDA warns of false positive results with BD SARS-CoV-2 Reagents for the BD Max System
The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and healthcare providers of an increased risk of a false positive result with Becton, Dickinson and Company (BD) SARS-CoV-2 Reagents for the BD Max System test.
In one study, the manufacturer found approximately three percent of results were false positive results.
The FDA recommends 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 with an alternate authorized test.
The BD SARS-CoV-2 Reagents for BD Max System test is only authorized for use in laboratories in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (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 received an Emergency Use Authorization on April 8, 2020.
The FDA is working with BD to resolve this issue. The FDA will continue to keep clinical laboratory staff, health care providers, manufacturers, and the public informed of new or additional information.
