Diagnosis by AMPLICOR PCR of Chlamydia trachomatis infection in urine samples from women and men attending sexually transmitted disease clinics.

Screening of urine specimens from men for Chlamydia trachomatis infection by a commercial PCR assay (AMPLICOR C. trachomatis Test; Roche Diagnostic Systems, Inc., Branchburg, N.J.) is a sensitive and specific noninvasive diagnostic assay. Since screening of women for C. trachomatis infection with the AMPLICOR C. trachomatis Test has been limited to use with endocervical swab specimens, we conducted an evaluation of the AMPLICOR C. trachomatis Test for the detection of C. trachomatis using female urine samples and compared the results of those obtained by in vitro culture and PCR of endocervical swab specimens. For 713 men we compared the performance of AMPLICOR C. trachomatis Test with urine specimens with that of culture of urethral specimens. For specimens that were PCR positive and culture negative, two additional tests were used to resolve the discrepancies: direct fluorescent-antibody assay (DFA) of sediment from a spun endocervical specimen culture vial and major outer membrane protein-based PCR of the sediment from the endocervical specimen culture vial. Of 525 urine specimens from females, 67 (12.8%) were PCR positive, and 41 (7.8%) endocervical specimens from the 525 women were culture positive. After resolution of the discrepancies, the resolved sensitivity of the urine PCR was 93.3%, whereas the sensitivity of endocervical swab specimen culture was 67.3%. Of 468 female endocervical swab specimens, 47 (10.0%) had a positive PCR result and 33 (7.0%) were culture positive. The resolved sensitivity of the endocervical swab specimen PCR was 86%. Of 415 matched female urine and endocervical swab specimens, there were 49 confirmed infections; 30 (61.2%) specimens were positive by culture of the endocervical swab specimen, 40 (81.6%) were positive by confirmed endocervical swab specimen PCR, 43 (87.8%) were positive by confirmed urine PCR, and all 49 (100%) were positive by either endocervical swab specimen PCR or urine PCR. For men, the resolved sensitivity of the urine PCR was 88%, and the sensitivity of culture was only 50.7%. These results indicate that urine PCR is highly sensitive for the detection of C. trachomatis in both women and men and provides a noninvasive technique for routine screening for chlamydial infection.