Introduction An automated and accurate laboratory assay would be of considerable utility to the diagnosis of syphilis and treatment follow-up. We compared the Sekure RPR (Rapid Plasma Reagin) test performed on the SK500 Clinical Chemistry System to RPR card test results.
Methods Serum samples were collected in the context of a 2 year observational cohort study of syphilis infected patients and controls. Syphilis was diagnosed using non-treponemal and treponemal testing. Sera collected at the time of diagnosis (M0) and at 3, 6, 9 and 12 months post-treatment were tested by a Macro-Vue RPR card test (RPR-C) (Becton Dickinson) and a Sekure RPR test (RPR-S) (Sekisui Diagnostics). RPR-S results are expressed in RPR units (R.U.), whereby 1 R.U. equals a 1-fold change in RPR-C titre. The agreement, linearity and reportable ranges were determined using RPR-C results as the gold standard. Linear regression was used to assess correlations from before and after implementation of an extra dilution step for samples with a strong suspicion of prozone effect.
Results In total, 451 samples from 150 participants were tested, including 120 new syphilis cases and 30 controls. All 30 controls tested negative. Initially there was a weak correlation between RPR-C and RPR-S values (r=0.15). Further analyses identified 72 RPR-S samples with a strong suspicion of prozone effect. We therefore included an extra dilution step (10x) and retested 60/72 samples; values within the expected range were obtained for 58 of them. After implementing the extra dilution step the correlation was moderate (r=0.61), increasing further to r=0.91 for samples with RPR-C titres≤128. Of the 92 samples that tested RPR-C positive and RPR-S negative, 8 were from M0 (RPR-C: 1–4), which would have led to missed diagnoses.
Conclusion A reasonable correlation was found between the tested methods for mid-range RPR-C results (titre ≤128). However, prozone may occur in samples with high antibody concentrations. More investigation is required to elucidate the false negative RPR-S results.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.