Abstract
The serological detection of antibodies to Treponema pallidum is essential to the diagnosis of syphilis. However, for the presence of cross-reaction, the specific antibody tests [e.g., enzyme-linked immunosorbent assay (ELISA)] always have false-positive results. In this study, we derived and validated the dissociation of urea in an attempt to alleviate the situation of false-positive antibodies to T. pallidum detected by ELISA. Six serum samples that were false-positive antibodies to T. pallidum detected by ELISA, and 16 control serum samples (8 sera positive for both specific IgG and IgM, and 8 IgG-positive and IgM-negative sera) were collected to select the appropriate dissociated concentration and time of urea. Our goal was to establish improved an ELISA method based on the original detection system of ELISA. The sensitivity of the improved ELISA was evaluated by 275 serum samples with class IgM-positive antibodies to T. pallidum. At 6 mol/L with 10 minutes dissociation of urea, 6 samples with false-positive antibodies to T. pallidum were converted to negative, and compared with true-positive antibodies to T. pallidum. The sensitivity of the improved ELISA was 100% by detecting the class IgM-positive antibodies to T. pallidum in sera of patients with syphilis. Considering the importance at the diagnosis of syphilis, antibodies to T. pallidum in serum samples should be retested by the improved ELISA method to avoid false-positive results.
Highlights
Syphilis is a sexually transmitted disease caused by the spirochete Treponema pallidum
We investigated whether the dissociation of urea could be used to distinguish true-positive from falsepositive results of antibodies to T. pallidum detected by enzyme-linked immunosorbent assay (ELISA), and whether the configuring mode of the improved ELISA, combined with the dissociation of urea, could alleviate the situation of false-positive antibodies to T. pallidum detected by ELISA
All the 297 serum samples used in this study had been stored frozen at -80 ̊C after being detected by ELISA for the class IgG and/or IgM antibodies to T. pallidum (Anti-T. pallidum antibody ELISA test kit, WanTai Biopharm, China), ELISA for the class IgM antibodies to T. pallidum (Anti-T. pallidum antibody(IgM) ELISA test kit, EUROIMMUN, Germany), and chemiluminescent immunoassay (CLIA) for quantifying the class IgG and/or IgM antibodies to T. pallidum (ARCHITECT Syphilis TP, Abbott Japan Co., Japan)
Summary
Syphilis is a sexually transmitted disease caused by the spirochete Treponema pallidum Pallidum) and is characterised by widespread tissue dissemination and chronic infection[1,2]. The disease continues to be a significant public health problem worldwide. The World Health Organization (WHO) estimates that 12 million new cases of syphilis occur each year, and more than 90% of them are in developing countries[3]. In 2012, WHO estimated 350,000 cases of adverse pregnancy outcomes due to syphilis, and congenital syphilis remains a leading.
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