Diagnosis of gonococcal infection in high risk women using a rapid test
Diagnosis of gonococcal infection in high risk women using a rapid test
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DOI：
10.1136/sti.2006.022566
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发表时间：
2006-12-01
影响因子：
3.6
通讯作者：
Salama, A.
中科院分区：
文献类型：
--
作者：
Benzaken, A. S.;Galban, E. G.;Salama, A.
目的：为了评估的性能和可接受性的NGThermo生物明星（GC OIA）的患者和医护人员诊断淋球菌感染与文化相比，使用修改后的Thayer Martin medium.Methods：本研究涉及326高危妇女阴道分泌物或转介的性伴侣尿道分泌物在性传播感染（STI）诊所在马瑙斯，巴西。从女性中收集的宫颈拭子用NG Biosar和改良Thayer Martin培养物作为参考标准试验进行检测。临床工作人员进行培训，以执行NG Biosstar的网站和文化进行了实验室的clinic.Results：淋球菌感染的患病率作为衡量的参考标准为15%（50/326）整体。在无症状参与者中，感染率为17.7%（25/141），在有症状的女性中为13.5%（25/185）（p = 0.3）。NG Biotar检测的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）以及95%置信区间（CI）均为60%。（46.4%至73.6%）、89.9%（86.2%至93.6%），55.6%（42.4%至68.8%）和92.6%（89.5%至95.7%）; 98.8%的研究参与者愿意在诊所等待约1小时的测试结果。发展中国家治疗性传播感染的综合症管理规程需要改进，因为如目前所述，这些规程导致对宫颈感染的过度治疗。在患者初次就诊时进行快速检测，如果检测结果呈阳性，则立即进行治疗，这将有助于提高诊断的准确性，也可用于筛查无症状的妇女。尽管NG Biosar的灵敏度和PPV较低，但仍可以提高治疗率，超过需要患者回访以获得结果并从治疗中获益的金标准测试。应开展使用淋病奈瑟氏菌感染快速床旁检测与综合征方法相比的成本效益研究，以评估其在发展中国家性病诊断和治疗中的价值。
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.