Bio-Rad Announces FDA Clearance of its BioPlex 2200 Syphilis Total & RPR Assay, a Novel Syphilis Testing Method

Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb), a global provider of life science research and clinical diagnostic products, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its BioPlex® 2200 Syphilis Total & RPR assay, a novel one-step universal testing method to aid in the diagnosis of syphilis infection. 

The BioPlex 2200 Syphilis Total & RPR (rapid plasma reagin) assay offers laboratories the first fully automated Treponemal/non-Treponemal dual assay, which simultaneously detects antibodies to T. pallidum and reagin antibodies as well as RPR titer (the level of antibody) determination for effective treatment monitoring. Compared to traditional manual RPR card tests, the automation of RPR testing offers labor savings, objective result reporting, and improved workflow to laboratories.

“The addition of the BioPlex 2200 Syphilis Total & RPR assay broadens our expanding BioPlex 2200 System infectious disease menu while offering laboratories a simplified approach to syphilis testing, and it is adaptable to any testing algorithm used by a laboratory,“ said John Hertia, Bio-Rad President, Clinical Diagnostics Group.

The release of the BioPlex 2200 Syphilis Total & RPR assay is the latest offering in Bio‑Rad’s growing infectious disease menu for the BioPlex® 2200 System, a fully automated multiplex technology platform. The BioPlex 2200 System provides clinical laboratories the capability to rapidly process or “multiplex” multiple individual tests that are traditionally processed separately, conserving patient sample volume and simplifying workflow.