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

Abstract

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 with 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.

Comparison of three commercially available amplification assays, AMP CT, LCx, and COBAS AMPLICOR, for detection of Chlamydia trachomatis in first-void urine

“…Because of the increased sensitivity of these nucleic acid amplification techniques, they recently have made possible the use of urine specimens for the detection of C. trachomatis in both men and women, thereby eliminating cumbersome sampling (3,5,9,14,25). In addition, amplification assays are now available in automated formats, standardizing performance in clinical microbiology laboratories.…”

Prevalencia de Chlamydia Trachomatis detectada por reacción en cadena de la polimerasa en un grupo de mujeres jóvenes sintomáticas y asintomáticas en Bogotá, Colombia

“…Los especímenes de orina se conservaron a -29 grados centígrados y se procesaron en el hemocentro de la Secretaría Distrital de Salud, usando la técnica de PCR, en el equipo COBAS (Comprehensive Bio-Analytical System) AMPLICOR CT (Roche). 27 Brevemente, una vez homogenizada la muestra se trató con una solución detergente para liberar el ADN contenido en los cuerpos reticulares de Chlamydia trachomatis que se encuentran dentro de las células epiteliales. Posteriormente se les agregó la solución diluyente para preparar el espécimen para la amplifi cación.…”

“…23 El método de análisis de sonda génica amplifi cada (AMP) tiene una sensibilidad entre el 49 y el 79% y una especifi cidad entre el 95 y el 97%; 17 la reacción en cadena de la ligasa tiene una sensibilidad entre el 93 y el 96% con una especifi cidad entre el 99 y el 100% 18,24,25 y el PCR Amplicor tiene una sensibilidad entre el 90 y el 100% y una especifi cidad entre el 99 y el 100%. [26][27][28][29][30] En este estudio se utilizó la técnica de PCR COBAS AMPLICOR CT (Roche Molecular System) 27 para determinar la prevalencia de infección por Chlamydia trachomatis en un grupo de mujeres jóvenes asintomáticas y un grupo de pacientes con leucorrea sintomática.…”

Correct samples for diagnostic tests in sexually transmitted diseases: which sample for which test?

“…Automated LCR and PCR assays on ¢rst-void urine (FVU) of women detected up to 30% more chlamydia-infected women than did endocervical swab culture [4,5]. Urine testing by amplifying methods is also recommended for women, and the sensitivity of FVU is similar to that of cervical samples [8,9]. However, there seem to be di¡erences between male and female urine, with a better performance pattern for male than for female urine.…”