DIAGNOSIS BY AMPLICOR PCR OF CHLAMYDIA-TRACHOMATIS INFECTION IN URINESAMPLES FROM WOMEN AND MEN ATTENDING SEXUALLY-TRANSMITTED DISEASE CLINICS

Screening of urine specimens from men for Chlamydia trachomatis infect ion by a commercial PCR assay (AMPLICOR C. trachomatis Test; Roche Dia gnostic Systems, Inc., Branchburg, N.J.) is a sensitive and specific n oninvasive diagnostic assay, Since screening of women for C. trachomat is infection with the AMPLICOR C. trachomatis Test has been limited to use with endocervical swab specimens, we conducted an evaluation of t he AMPLICOR C. trachomatis Test for the detection of C. trachomatis us ing female urine samples and compared the results with those obtained by in vitro culture and PCR of endocervical swab specimens. For 713 me n we compared the performance of AMPLICOR C. trachomatis Test with uri ne specimens with that of culture of urethral specimens. For specimens that were PCR positive and culture negative, two additional tests wer e 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 endoce rvical specimen culture vial. Of 525 urine specimens from females, 67 (12.8%) were PCR positive, and 41 (7.8%) endocervical specimens from t he 525 women were culture positive. After resolution of the discrepanc ies, the resolved sensitivity of the urine PCR was 93.3%, whereas the sensitivity of endocervical swab specimen culture was 67.3%. Of 468 fe male 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 an d endocervical swab specimens, there were 49 confirmed infections; 30 (61.2%) specimens were positive by culture of the endocervical swab sp ecimen, 40 (81.6%) were positive by confirmed endocervical swab specim en PCR, 43 (87.8%) were positive by confirmed urine PCR, and all 49 (1 00%) were positive by either endocervical swab specimen PCR or urine P CR. For men, the resolved sensitivity of the urine PCR was 88%, add th e sensitivity of culture was only 50.7%. These results indicate that u rine PCR is highly sensitive for the detection of C. trachomatis in bo th women and men and provides a noninvasive technique for routine scre ening for chlamydial infection.