Use of the polymerase chain reaction for the detection of Chlamydia trachomatis from endocervical and urine specimens in an asymptomatic low-prevalence population of women.

The Amplicor Chlamydia trachomatis test is a polymerase chain reaction (PCR)-based methodology used for the detection of a cryptic plasmid found in C. trachomatis. It was evaluated in comparison with cell culture and the Microtrak II Chlamydia enzyme immunoassay (EIA) for the detection of C. trachomatis in urogenital specimens from women. Endocervical swabs were collected from 993 women attending the women's unit at the Mount Sinai Hospital in Toronto. In addition, concomitant first void urine specimens were collected from 394 of these women for PCR testing only. As compared with culture of the endocervical specimens, PCR and EIA had a sensitivity, specificity, positive predictive value and negative predictive value of 84.6%, 99.2%, 57.9%, and 99.8% and 61.5%, 99.7%, 72.7%, and 99.5%, respectively. As compared with the secondary gold standard of a positive culture and/or a positive PCR using a primer to the major outer membrane protein the sensitivity, specificity, positive, and negative predictive values for culture were 72.2%, 100%, 100%, and 99.5%, respectively. For the Amplicor PCR and EIA the results were 88.9%, 99.7%, 84.2%, and 99.9% and 61.1%, 99.9%, 91.7%, and 99.6%, respectively. When the urine PCR was compared with the same standard, the test had a sensitivity of 91.7% and a specificity of 99.5%. Based on this study the Amplicor C. trachomatis test was found to be sensitive and specific for the detection of C. trachomatis in both endocervical and urine specimens.