Evaluation of a domestic nucleic acid detection reagent for Chlamydia trachomatis in reproductive tract specimens
Objective The study evaluated the performance of a domestic nucleic acid detection reagent for detecting Chlamydia trachomatis in reproductive tract specimens.Methods Patients were recruited from three hospitals.Reproductive tract specimens were collected,including urine samples and urethral swabs from male patients,as well as urine samples,vaginal swabs,and cervical swabs from female patients.The Cobas 4800CT/NG system(Roche)was used as a reference to assess the performance of the domestic DNA detection reagent.Results A total of 457 patients were enrolled,with 248 being female.The following number of specimens were collected:456 urine samples,205 male urethral swabs,248 vaginal swabs,and 248 cervical swabs.The sensitivity and specificity of the domestic reagent were lower when using urinc samples(sensitivity=61.8％,95％CI:43.6％-77.3％;specificity=95.0％,95％CI:92.4％-96.8％).The domestic reagent demonstrated good performance for detecting C.trachomatis in cervical swabs(sensitivity=80.0％,95％CI:51.4％-94.7％;specificity=98.7％,95％CI:96.0％-99.7％),vaginal swabs(sensitivity=80.0％,95％CI:51.4％-94.7％;specificity=99.1％,95％CI:96.6％-99.9％),and poor performance in male urethral swabs(sensitivity=50.0％,95％CI:26.9％-73.2％;specificity=84.0％,95％CI:77.7％-88.8％).Conclusions This study suggests that the domestic reagent has good sensitivity and specificity for detecting C.trachomatis in the female reproductive tract using cervical swabs and vaginal swabs.However,sensitivity is lower when using urine and male urethral swabs.This may be due to factors such as improper specimen storage,low nucleic acid extraction efficiency,unsuitable swabs,or an insufficient number of samples used in the analysis.
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