Comparison of real-time PCR assay with a commercial rapid test based on the immunochromatographic principle for the detection of Chlamydia trachomatis in seminal fluid and urine specimens.

Chlamydia trachomatis is the most common sexually transmitted bacterial infection worldwide, with the highest prevalence in sexually active young women. Since most chlamydial infections are asymptomatic, facilitating the transmission of the pathogen in the population, regular screening is recommended for at-risk sexually active individuals. Hence, a sensitive, specific, inexpensive diagnostic test that can be executed efficiently and quickly to yield results would be helpful. In this study, we evaluated the performance (sensitivity and specificity) of the Chlamydia Rapid Test Device, an inexpensive rapid test based on immunochromatographic analysis. We then compared these results to those obtained using real-time PCR, the gold standard for C. trachomatis testing. Seminal fluid and urine specimens of male subjects were tested. The rapid test was applied to 220 seminal fluid samples, showing a sensitivity of 0%. On the other hand, used in 114 urine specimens, the rapid test showed 37.5% and 100% sensitivity and specificity, respectively. Hence, the Chlamydia Rapid Test Device was shown to be insufficiently sensitive to be recommended as a screening test and diagnostic method for the detection of C. trachomatis in symptomatic and asymptomatic subjects. Finally, the present investigation showed an infection prevalence of 5% calculated using seminal fluid, with a mean age of 28 years.