Background Laboratory diagnostic of syphilis is based on both treponemal and non-treponemal assays. While automated treponemal assays are available, non-treponemal antibody testing continue to require extensive hands on time. The BioPlex 2200 Syphilis Total & RPR assay by Bio-Rad Laboratories is a fully automated assay that detects both treponemal and non-treponemal antibodies with on board RPR titer capability.
Methods We compared the BioPlex Total & RPR assay with the BiopPex IgG assay and with the Wampole Impact RPR card test for the treponemal and non-treponemal antibodies detection respectively. A total of 504 prospective sera sent to our laboratory for syphilis testing were tested with both BioPlex assays to establish agreement of treponemal results. Also, a panel of 52 sera with known titer values was provided by our reference laboratory. These sera were tested with the BioPlex Total & RPR assay and the manual Wampole RPR card to compare titer results, using essential agreement within 1 dilution range and correlation of log2 transformed titer values with Spearman coefficient.
Results Of the 504 sera tested, 112 were positive for treponemal antibodies with BioPlex Total & RPR and 109 with BioPlex IgG. Positive, negative and overall agreements were 95% (104/109)(95% CI [89%, 98%]), 98% (387/395)(95% CI [96%, 99%]) and 97% (491/504)(95% CI [95%, 99%]) respectively for these sera. Essential agreement within 1 dilution of quantitative RPR titer results for the 52 sera panel was 90% and the Spearman correlation coefficient of titers obtained with the two assays was 0.926 with a p <0.001.
Conclusion The BioPlex 2200 Syphilis Total & RPR assay is a fully automated assay that compares favorably with the BioPlex 2200 Syphilis IgG assay and that yields non treponemal titers that correlates favorably with a traditional manual RPR card test. Reliable automated non treponemal assays are needed.
Disclosure No significant relationships.
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