摘要

Background: Urogenital infection with Chlamydia trachomatis is the most commonly diagnosed sexually transmitted infection in the developed world. Accurate measurement and therefore understanding the seroprevalence of urogenital C trachomatis infections requires a rigorously optimised and validated ELISA. Previous ELISAs based on the C trachomatis plasmid-encoded protein, PGP3, have been described but lack standardisation and critical controls or use a less common PGP3 as the capture antigen. Methodology/principal findings: A sensitive and specific indirect ELISA was developed based on recombinant PGP3 derived from a urogenital strain of C trachomatis, serovar E (pSW2), using a rigorous validation protocol. Serum samples were collected from 166 genitourinary medicine (GUM) clinic patients diagnosed as positive or negative for urogenital C trachomatis infection by nucleic acid amplification testing (NAATs). Overall sensitivity and specificity compared to NAATs was 68.18% and 98:0%, respectively. Sensitivities for female and male samples were 71.93% and 64.15%, respectively. Comparison of samples from these patients diagnosed positive for C trachomatis by NAAT and patients diagnosed negative by NAAT revealed statistical significance (p <= 0.0001). Conclusions: We have developed and validated a sensitive and specific ELISA to detect anti-PGP3 antibodies as an indicator of past and current infection to C trachomatis using PGP3 from a common urogenital strain. It is anticipated that this assay will be used for seroepidemiological analysis of urogenital C trachomatis in populations.

  • 出版日期2017-6