12/20/2021: Lab Alert: Possible False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR Test Kit
The Laboratory Outreach Communication System (LOCS) issued an update to this message on 03/24/2022. Please refer to the updated LOCS message for the most current information.
Audience: Clinical Laboratory Professionals
Level: Laboratory Alert
On December 17, 2021, the U.S. Food and Drug Administration (FDA) published a Letter to Health Care Providers to alert clinical laboratory staff and health care providers that false reactive (also called “false-positive”) Rapid Plasma Reagin (RPR; non-treponemal) test results can occur when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR Test Kit.
Additional studies are underway to determine the extent of the issue. It is not known if other RPR tests may be affected similarly. Treponemal testing for syphilis is not impacted by this issue.
Refer to the Letter to Health Care Providers for more information and to see FDA recommendations for clinical laboratories who use the Bio-Rad BioPlex 2200 Syphilis Total & RPR Test Kit.
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Thank you,
The Laboratory Outreach Communication System
Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)
Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)
Centers for Disease Control and Prevention (CDC)