Direct detection of Chlamydia trachomatis in urine specimens from symptomatic and asymptomatic men by using a rapid polymerase chain reaction assay

Abstract

Screening for Chlamydia trachomatis infection in men has traditionally been limited to men who present with urethral symptoms, thereby limiting the detection of asymptomatic chlamydia infection in men. In order to effectively screen both symptomatic and asymptomatic men, we evaluated a newly developed polymerase chain reaction (PCR) assay, Amplicor C. trachomatis, from Roche Molecular Systems for the detection of C. trachomatis in urine specimens in comparison with urethral culture. A total of 530 male urine specimens were collected from 322 symptomatic and 208 asymptomatic men attending two sexually transmitted disease clinics in Baltimore, Md. The prevalence of C. trachomatis by culture was 9.8% (10.6% in symptomatic men and 8.2% in asymptomatic men). Compared with culture, the sensitivity of the PCR was 92.8%, the specificity was 94.7%, the positive predictive value was 68.4%, and the negative predictive value was 99.1%. Discrepant results between culture and PCR were further analyzed by direct fluorescent-antibody staining of elementary bodies in urine sediment and in culture transport vials and by major outer membrane protein PCR of transport media for specimens with negative culture. The revised sensitivity and specificity of PCR for urine were 95.0 and 99.8%, respectively, and the positive and negative predictive values were 98.7 and 99.1%, respectively. The sensitivity of culture compared with PCR and/or direct fluorescent-antibody staining was 68.4%. These results indicate that the PCR assay is a highly sensitive and specific assay for the detection of C. trachomatis in male urine specimens and provides a noninvasive technique for routine screening of chlamydia infection in both symptomatic and asymptomatic men.

PCR-based diagnostics for infectious diseases: uses, limitations, and future applications in acute-care settings

“…113 One example can be seen in assessments of novel nucleic acid-based assays in detecting C trachomatis. 114,115 In these studies, "false positives" (DNA-amplification positive and tissue culture negative) were adjudicated by either antigen detection methods or another well-established DNA-amplification test. Despite its popularity, recent concerns have been raised regarding the potential bias incurred by discrepant analysis in favour of the new tests.…”

P3.379 Comparison in 2004 and 2011 on the Efficacy of Partner Notification For Chlamydia Trachomatis Among Young Adults in Youth Health Centres in Uppsala County, Sweden

“…8,9 In men, the infection accounts for 30-50% of visits to clinics for sexually transmitted diseases for non-gonococcal urethritis. 10,11 However, an often unrecognized aspect of STI, including bacterial STI, is how frequently persons with these infections have no symptoms or do not recognize the symptoms. In both genders, clinical signs and symptoms of C. trachomatis infection are mild or non-specific in up to 70% of infected cases 12 and the perpetuation of infection may be explained by describing the identified cases metaphorically as the tip of the iceberg.…”

Polymerase chain reaction assay with urine specimens in the diagnosis of acute Chlamydia trachomatis infection in women

“…The sensitivity of PACE 2 assay has been comparable to that of cell culture (96.7-100%), 1,2 and the Amplicor PCR has been shown to be even more sensitive than culture. [3][4][5] In a recent study, we demonstrated an equal sensitivity (90% vs. 88%) between Amplicor PCR and PACE 2 performed on cervical swab specimens obtained from a high-risk population. 6 Studies on the use of PCR with male urine specimens have demonstrated an enhanced sensitivity compared to that achieved by conventional chlamydial cell culture with urethral swab specimens.…”