Detection of Chlamydia trachomatis and Neisseria gonorrhoeae by ligase chain reaction-based assays with clinical specimens from various sites: implications for diagnostic testing and screening.

Ligase chain reaction (LCR)-based tests for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae infections in men and women attending a sexually transmitted disease clinic were evaluated. LCR testing of urethral swab and urine specimens from men and cervical swab and urine specimens from women was compared with culture of male urethral swabs and female cervical and urethral swabs, respectively. An expanded "gold standard" was defined as a positive culture or at least one specimen confirmed to be positive by LCR testing. The prevalence of C. trachomatis infection as detected by cell culture was 7.0% among 614 men and 5.0% among 602 women. By LCR, these values increased to 11.4 and 9.9% with urethral swabs and urine, respectively, for men and 9.6 and 9.1% with cervical swabs and urine, respectively, for women. Relative to the expanded gold standard, the sensitivity of cell culture with male urethral swabs or female cervical swabs was 57.3 and 45.5%, respectively, compared with corresponding values of 93.3 and 87.9% for LCR. The sensitivity of LCR with urine specimens was 77.3 and 78.8% for men and women, respectively. The prevalence of N. gonorrhoeae infection as detected by culture was 5.9% among 220 men and 2.9% among 383 women. The corresponding values were 8.2 and 5.5%, respectively, by LCR testing of swabs. Prevalence values by LCR testing of urine were 7.3% for men and 2.9% for women. The sensitivity of culture was 72.2% for men and 50.0% for women. The sensitivities of LCR were 100% with male urethral swabs, 95.4% with female cervical swabs, 88.9% with male urine, and 50.0% with female urine. These results indicate that the LCR-based assays represent a major improvement in C. trachomatis and N. gonorrhoeae diagnostics. The sensitivity of testing of urethral or cervical swabs by LCR was markedly greater than that by culture. The sensitivity of testing female or male urine specimens was equal to or greater than that of culturing cervical or urethral specimens. LCR testing of urine specimens may prove useful for screening for C. trachomatis.

Detection of Chlamydia trachomatis infection in urine samples from men and women by ligase chain reaction.

The suitability of urine specimens from women and men for the detection of Chlamydia trachomatis infection by a ligase chain reaction (LCR)-based assay with plasmid primers was examined with a group of patients attending a sexually transmitted disease clinic in Amsterdam, The Netherlands. Cervical specimens from 15 of 237 (6.3%) women tested positive for C. trachomatis by cell culture. Of the 25 (10.5%) female urine samples that tested positive by the plasmid-LCR assay, 13 were obtained from cervical culture-positive women. Nine of the 12 plasmid-LCR-positive urine samples from cervical culture-negative women were confirmed to be positive by a second LCR assay with primers based on chromosomal DNA. Urethral specimens from 24 of 258 (9.3%) men were positive for C. trachomatis infection by cell culture. Of the 25 (9.7%) urine samples that tested positive by plasmid-LCR, 20 were from culture-positive men. All five of the LCR-positive urine samples from culture-negative men were confirmed to be positive by the LCR with chromosomal DNA primers. Relative to cell culture, testing by plasmid-LCR analysis of male urine samples had a sensitivity of 83.3% and a specificity of 97.9%; after resolution of discordant samples, these values were 86.2 and 100%, respectively. In the study with women, the sensitivities of plasmid-LCR analysis of cervical and urine specimens in comparison with cervical cell culture were 93.3 and 86.7%, respectively. After resolution of discrepant samples, the sensitivities of the plasmid-LCR test for cervical swabs and female urine samples were 96.3 and 92.6%, respectively. These results indicate that the plasmid-LCR-based assay is a very reliable, sensitive, convenient test for the detection of C. trachomatis infection in female and male urine specimens.