Systematic reviews of point-of-care tests for the diagnosis of urogenital Chlamydia trachomatis infections.

ABSTRACT

BACKGROUND: WHO estimates that 131 million new cases of urogenital Chlamydia trachomatis (CT) infections occur globally every year. Most infections are asymptomatic. Untreated infection in women can lead to severe complications. Screening and treatment of at-risk populations is a priority for prevention and control. OBJECTIVES: To summarise systematic reviews of the performance characteristics of commercially available point-of-care tests (POCT) for screening and diagnosis of urogenital CT infection. METHODS: Two separate systematic reviews covering the periods 2004-2013 and 2010-2015 were conducted on rapid CT POCTs. Studies were included if tests were evaluated against a valid reference standard. RESULTS: In the first review, 635 articles were identified, of which 11 were included. Nine studies evaluated the performance of eight antigen detection rapid POCTs on 10 280 patients and two studies evaluated a near-patient nucleic acid amplification test (NAAT) on 3518 patients. Pooled sensitivity of antigen detection tests was 53%, 37% and 63% for cervical swabs, vaginal swabs and male urine, and specificity was 99%, 97% and 98%, respectively. The pooled sensitivity and specificity of the near-patient NAAT for all specimen types were >98% and 99.4%, respectively. The second review identified two additional studies on four antigen detection POCTs with sensitivities and specificities of 22.7%-37.7% and 99.4%-100%, respectively. A new two-step 15 min rapid POCT using fluorescent nanoparticles showed performance comparable to that of near-patient NAATs. CONCLUSIONS: The systematic reviews showed that antigen detection POCTs for CT, although easy to use, lacked sufficient sensitivity to be recommended as a screening test. A near-patient NAAT shows acceptable performance as a screening or diagnostic test but requires electricity, takes 90 min and is costly. More affordable POCTs are in development.