Diagnosis of gonococcal infection in high risk women using a rapid test

Benzaken, AS; Galban, EG; Antunes, W; Dutra, JC; Peeling, RW; Mabey, D; Salama, A; (2006) Diagnosis of gonococcal infection in high risk women using a rapid test. Sexually transmitted infections, 82. V26-V28. ISSN 1368-4973 DOI: https://doi.org/10.1136/sti.2006.022566

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Objective: To assess the performance and acceptability for patients and health care workers of the NGThermo Biostar ( GC OIA) to diagnose gonococcal infection compared with culture using modified Thayer Martin medium. Methods: This study involved 326 high-risk women presenting with vaginal discharge or referral by sexual partner with urethral discharge at a sexually transmitted infections (STI) clinic in Manaus, Brazil. Endocervical swabs collected from the women were tested with both the NG Biostar and modified Thayer Martin culture as the reference standard test. Clinic staff were trained to perform the NG Biostar on site and the culture was performed in the laboratory of the clinic. Results: The prevalence of gonococcal infection as measured by the reference standard was 15% (50/326) overall. Among asymptomatic participants, the prevalence of infection was 17.7% (25/141) and among symptomatic women it was 13.5% (25/185) (p = 0.3). Sensitivity, specificity, positive predictive value ( PPV) and negative predictive value (NPV) for the NG Biostar test, with 95% confidence intervals (CI), were 60% (46.4% to 73.6%), 89.9% (86.2% to 93.6%), 55.6% (42.4% to 68.8%), and 92.6% (89.5% to 95.7%), respectively; 98.8% of study participants were willing to wait approximately 1 hour in the clinic for test results. Conclusion: Syndromic management protocols for treatment of STI in developing countries require refinement because, as currently described, they lead to over-treatment of cervical infection. A rapid test done during patients' initial presentation and leading to immediate treatment if positive would help improve the accuracy of diagnosis and could also be used to screen asymptomatic women. Even though the NG Biostar had a low sensitivity and PPV, which is less than ideal, it could still improve the rates of treatment over the gold standard test that requires return visits for patients to receive results and to benefit from treatment. Cost-effectiveness studies using rapid point-of-care tests for Neisseria gonorrhoeae infection compared to the syndromic approach should be carried out to assess their value in STI diagnosis and treatment in developing nations.

Item Type: Article
Keywords: SEXUALLY-TRANSMITTED INFECTIONS, NEISSERIA-GONORRHOEAE, SYNDROMIC, MANAGEMENT, VAGINAL DISCHARGE, VAGINITIS, Adolescent, Adult, Consumer Satisfaction, Female, Gonorrhea, diagnosis, Humans, Middle Aged, Neisseria gonorrhoeae, isolation & purification, Point-of-Care Systems, standards, Reference Standards, Risk Factors, Sensitivity and Specificity, Vaginal Discharge, microbiology
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Research Centre: Centre for Maternal, Reproductive and Child Health (MARCH)
PubMed ID: 17118954
Web of Science ID: 244486800006
URI: http://researchonline.lshtm.ac.uk/id/eprint/9519


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