Bio-Rad Labs Receives FDA Clearance for BioPlex 2200 Syphilis Total & RPR Assay

The FDA has granted marketing clearance to Bio-Rad Labs for its BioPlex 2200 syphilis total and RPR assay, which is a one-step universal testing method to aid in the diagnosis of syphilis infection.

The assay provides laboratories an automated Treponemal/non-Treponemal dual assay that simultaneously detects antibodies to T. pallidum and reagin antibodies as well as RPR titer (the level of antibody) determination for effective treatment monitoring.

The automation of RPR testing offers labor savings, objective result reporting and improved workflow to laboratories. — Cynthia Jessup