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Bio-Rad Gets FDA Clearance for Syphilis Assay

NEW YORK (360Dx) – Bio-Rad Laboratories said today that the US Food and Drug Administration has cleared for marketing its BioPlex 2200 Syphilis Total & RPR (rapid plasma reagin) assay, a one-step universal testing method to aid in the diagnosis of syphilis infection.

Bio-Rad said that the test offers labs the first fully automated Treponemal/non-Treponemal dual assay. The assay simultaneously detects antibodies to T. pallidum and reagin antibodies as well as RPR titer determination for treatment monitoring, and according to Bio-Rad offers labor savings and improved workflow for labs compared to traditional manual testing methods.

"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," John Hertia, president of Bio-Rad's Clinical Diagnostics Group, said in a statement.

The BioPlex 2200 is a fully automated, random-access, multiplex test platform that runs tests for infectious diseases, autoimmune disorders, and other immunoassays.