Objective Evaluate the diagnostic accuracy of rapid tests (RTs) for C. trachomatis (CT), N. gonorrheae (NG), and syphilis at the point of care for management of women with symptoms of lower genital tract infection (LGTI).
Materials and Methods: Diagnostic validity study assembled in a cohort study of sexually active women 14 to 49 years old, consulting with symptoms of LGTI at three outpatient facilities in Bogotá, Colombia in 2010, after ethics board approval. Exclusion criteria: hysterectomy, pregnancy, or receiving antibiotics in the 7 previous days. Sampling: sequential. RTs evaluated: Acon® duo and Acon plate® (Acon, San Diego, CA, USA) for NG. Acon® Plate, Acon Duo and QuickVue® (Quidel Corporation, San Diego, CA, USA). for CT They were compared against polymerase chain reaction (PCR) AMPLICOR C.trachomatis/N. gonorrhoeae test (Roche Diagnostic Systems, Inc., Branchburg, N.J.). Bioline® Syphilis 3.0 (Standard Diagnostics, Inc., Kyunggi-do, South Korea) and ACON® Syphilis for syphilis and were compared to a positive RPR and TPHA. Sensitivity (S), specificity (Sp), positive and negative likelihood ratios LR (+), LR (-) were calculated.
Results 1410 subjects recruited. The prevalence of NG and CT with PCR was 1.4% (19/1376) and 9.6% (133/1379) respectively. The prevalence of syphilis with RP and TPHA was 0.9% (12/1400). RTs for syphilis showed > 90% sensitivity and 100% specificity. RTs for C trachomatis showed a low sensitivity between 22 – 37% and a 99% specificity, RTs for N gonorrhoeae showed 97%.
Conclusions In women with symptoms of LGTIs RTs used at the point of care for syphilis have a sensitivity > 90%. RTs for CT have sensitivity < 40% and Rts for NG have sensitivity < 12.5% %.
Funded by Colciencias (Colombia) Grant:621 2009.
- Molecular techniques
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