The Wall Street Journal reported this morning that the company is probing reports of false positives from assays analyzed through its handheld, point-of-care Veritor Plus system.
A Becton Dickinson spokesperson confirmed that the company is aware that a small number of nursing homes in the U.S. are reporting multiple false-positive results on the point-of-care system.
“These reports do not reflect the results of BD clinical studies conducted using the BD Veritor Plus system, where the sampling data showed 98% to 100% specificity (negative percent agreement),” the spokesperson told MassDevice in a statement via email. “Following our standard quality management system processes, upon learning of these reports, BD immediately contacted the sites, and we are actively investigating the situation to obtain additional details. Our quality investigation is ongoing, however, as of Sept. 15, there have been no issues found with the BD Veritor Plus instruments or tests.
“BD takes its responsibility very seriously under our agreement with the U.S. Department of Health and Human Services (HHS) to provide more than 11,000 nursing homes with high-quality and reliable tests to support their efforts to protect residents and staff from COVID-19 BD is providing a robust array of training tools to support the use of BD Veritor Plus system and to ensure successful implementation of the nursing home initiative.”
Last week, the Franklin Lakes, N.J.-based company reported that, in a head-to-head, 361-patient study in which a cross-sectional population was tested for the detection of SARS-CoV-2 using the BD Veritor Plus and the Quidel Sofia 2 SARS AFI point-of-care platforms, results showed equivalent performance between the systems.
In July, the FDA had warned about an increased risk of false-positive results with the BD Max System SARS-CoV-2 tests, which differ from the BD Veritor Plus.
The American Health Care Association/National Center for Assisted Living did not immediately respond to request for comment. This story may be updated.