Comparison of manual Amplicor PCR, Cobas Amplicor PCR, and LCx assays for detection of Chlamydia trachomatis infection in women by using urine specimens.

We compared the Roche Amplicor PCR, Roche Cobas Amplicor PCR, and Abbott LCx assays by using urine specimens for the detection of Chlamydia trachomatis infections in a female population. First-catch urine and endocervical swab specimens were collected from a total of 442 patients. Urine specimens were tested by the manual Roche Amplicor PCR, the automatic Roche Cobas Amplicor PCR, and the Abbott LCx assays as instructed by the manufacturers. For the Cobas Amplicor PCR, the internal control protocol was used for every specimen to reveal the presence of polymerase inhibitors. Cell culture of cervical specimens was used as a reference method. Of 442 patients, 50 (11.3%) were confirmed to have chlamydial infection. The diagnostic sensitivity and specificity of cell culture with cervical swab specimens were 88 and 100%, respectively. With urine specimens the sensitivity and specificity for the manual Amplicor PCR assay were 100 and 99.7%, respectively; those for the automatic Cobas Amplicor PCR assay were 94 and 99.2%, respectively; and those for the LCx assay were 94 and 100%, respectively. Thus, all amplification methods with urine specimens proved to be highly sensitive and specific for the detection of C. trachomatis infection in women. No statistically significant differences in the test performances could be demonstrated for specimens from this population. All three amplification techniques with urine specimens proved to be superior to cell culture with cervical swab specimens in diagnosing C. trachomatis infections in women.