Poor Performance of the Chlamydia Rapid Test Device for the Detection of Asymptomatic Infections in South African Men: A Pilot Study.

Abstract

Background. To the best of our knowledge, there have been no published reports on the diagnostic performance of the Chlamydia Rapid Test (CRT) Device for male urine samples. We evaluated the performance of the CRT Device when compared with that of the BD ProbeTec ET PCR Assay in a population of asymptomatic men. Methods. The study enrolled 100 men between June and July 2015. From each consenting male, 20-30 mL of urine was collected. Sensitivity and specificity of the rapid test compared to PCR were calculated. All analysis was performed in STATA version 13. Results. All men had valid rapid and PCR test results. The test showed a low sensitivity against PCR (20%) (95% CI 3.7-6.2%); however, an excellent specificity was observed (100%) (one sided 97.5% CI: 96.0-100). Conclusions. This test was not found to be suitable as a screening tool for genital Chlamydia infections in men. Our findings emphasize the need for more sensitive POC tests to be developed since the current approach for the management of STIs in Africa is confounded by poor sensitivity and specificity resulting in many infected individuals not being treated.