Objective: To determine the diagnostic performancesof six Chinese PCR kits for detection of Chlamydiatrachomatis in patients with sexually transmitteddiseases using cell culture and LCR as references.Methods: Endocervical or urethral swab specimenswere collected from 673 patients attending STDclinics in Beijing, Shanghai, Nanjing and Tianjin. C.trachomatis culture and PCR were performed onspecimens from all patients while LCR detection wasperformed only on specimens with discordant cultureand PCR results.Results: Of the 616 patients, 6.3% (39) wereculture-positive while 23.5% to 28.7% were positiveby PCR testing. Compared to cell culture, the sensi-tivity of all six PCR methods was 90% or higher. In200 cases with discrepant reports, LCR and PCRshowed excellent consistency (YI index: 0.523-0.881 ), the sensitivity and specificity of PCR methodswere 83.9%- 98.6% and 66.7%- 94.7% respectively,while PCR2 showed the highest YI index (0.881). Withthe reference standard defined as culture positive orLCR positive plus at least one PCR positive fordiscrepant results, we found that the specificity andsensitivity of all six Chinese PCR kits were higherthan 95% and 85%, respectively.Conclusions: Domestically-produced PCR kits forChlamydia trachomatis detection are highly sensi-tive and specific, however, quality control remainsimportant in their clinical application.
