ABSTRACT
BACKGROUND: In high-volume laboratories, enzyme immunoassay (EIA) is the most commonly used method of detecting Chlamydia trachomatis. The optimal specimen for detecting C trachomatis is a combined urethral and cervical swab. OBJECTIVE: To compare EIA with the combined urethral and cervical swab with polymerase chain reaction (PCR) on urine alone and urine mixed with cervical cells. PATIENTS AND METHODS: Phase 1 of the study included 752 sets of specimens used for comparison. In phase 2, another 212 samples of urine and urine plus cervical cells were added to the study for comparison of the 2 specimen types using PCR. RESULTS: In phase 1, 648 samples were negative and 76 were positive by all 3 methods and specimen combinations. Enzyme immunoassay was able to detect 81 positive samples (10.8%), whereas PCR on urine alone detected 97 positive samples (12.9%) and PCR on urine plus cervical cells detected 102 positive samples (13.6%), giving a sensitivity of 75%, 93.3%, and 98. 1% respectively. In phase 2, PCR on urine alone detected 119 positive samples (12.3%) and PCR on urine plus cervical cells detected 127 positive samples (13.1%), with a sensitivity of 92.2% and 98.5%, respectively. CONCLUSION: Polymerase chain reaction on urine alone or urine plus cervical cells is superior to EIA on combined cervical and urethral swabs. There is a slight advantage of adding cervical cells to the urine compared with the urine specimen alone when PCR is used as the assay for detection. The total inhibition rate in our female population is only 3.1% when PCR is used.
Subject(s)
Cervix Uteri/microbiology , Chlamydia Infections/diagnosis , Chlamydia trachomatis/isolation & purification , Immunoenzyme Techniques , Polymerase Chain Reaction/methods , Urethra/microbiology , Urinary Tract Infections/diagnosis , Uterine Cervical Diseases/diagnosis , Cervix Uteri/pathology , Female , Humans , Predictive Value of Tests , Reproducibility of Results , Sensitivity and Specificity , Sexually Transmitted Diseases/microbiology , Urethra/pathology , Urine/microbiology , Vaginal SmearsABSTRACT
The new Sanofi Diagnostics Pasteur Chlamydia Microplate EIA shortened assay was evaluated by comparison with the original standard assay and cell culture. A total of 853 paired male and female genital tract specimens was tested with both Sanofi Chlamydia Microplate EIA shortened and standard assays and the results were compared with those of cell culture. For confirmation, a blocking assay run in the shortened format was used. Discrepancies between the three methods were resolved by a direct fluorescent antibody (DFA) test on the EIA samples or the culture retentate, or both. After resolution of discrepant results, the standard assay had a sensitivity, specificity, positive predictive value and negative predictive value of 98.5%, 100%, 100% and 99.9%, respectively. The shortened assay results were 100%, 100%, 100% and 100%, respectively. The shortened assay takes approximately 1.5 h less time than the standard assay and this study demonstrated that they have equivalent sensitivity and specificity. The improvement in turnaround time enables results to be reported on the same day.
