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The cutoff values were established in the feasibility phase of bioplex 2200 syphilis total & rpr assay development using native human samples from apparently healthy subjects, patients sent. We evaluated the clinical performance of this assay at a tertiary medical center with a high syphilis prevalence. Laboratories considering a switch from manual to automated rpr should ensure that they communicate with clinicians about the potential differences between automated and manual rpr titers
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The following tables summarize the similarities and differences between the bioplex 2200 syphilis total & rpr kit and the predicate devices used in comparative studies with the bioplex 2200. Recently, the fda cleared the fully automated bioplex 2200 syphilis total & rpr assay for the detection of treponemal and nontreponemal antibodies For simultaneous detection of five of the most clinically relevant antibodies.
