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首页> 外文期刊>Sexually transmitted diseases >Performance of a Dual Human Immunodeficiency Virus/Syphilis Rapid Test Compared With Conventional Serological Testing for Syphilis and Human Immunodeficiency Virus in a Laboratory Setting: Results From the Zimbabwe STI Etiology Study
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Performance of a Dual Human Immunodeficiency Virus/Syphilis Rapid Test Compared With Conventional Serological Testing for Syphilis and Human Immunodeficiency Virus in a Laboratory Setting: Results From the Zimbabwe STI Etiology Study

机译：双人免疫缺陷病毒/梅毒的性能与实验室环境中的梅毒和人类免疫缺陷病毒的常规血清学检测相比：津巴布韦STI病因研究的结果

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Background Dual human immunodeficiency virus (HIV)/syphilis rapid, point-of-care testing may enhance syphilis screening among high-risk populations, increase case finding, reduce time to treatment, and prevent complications. We assessed the laboratory-based performance of a rapid dual HIV/syphilis test using serum collected from patients enrolled in the Zimbabwe Sexually Transmitted Infections (STI) Etiology study. Methods Blood specimens were collected from patients presenting with STI syndromes in 6, predominantly urban STI clinics in different regions of Zimbabwe. All specimens were tested at a central research laboratory using the Standard Diagnostics Bioline HIV/Syphilis Duo test. The treponemal syphilis component of the dual rapid test was compared with the Treponema pallidum hemagglutination assay (TPHA) as a gold standard comparator, both alone or in combination with a nontreponemal test, the rapid plasma reagin test. The HIV component of the dual test was compared with a combination of HIV rapid tests conducted at the research laboratory following the Zimbabwe national HIV testing algorithm. Results Of 600 men and women enrolled in the study, 436 consented to serological syphilis and HIV testing and had specimens successfully tested by all assays. The treponemal component of the dual test had a sensitivity of 66.2% (95% confidence interval [CI], 55.2%-77.2%) and a specificity of 96.4% (95% CI, 94.5%-98.3%) when compared with TPHA; the sensitivity increased to 91.7% (95% CI, 82.6%-99.9%) when both TPHA and rapid plasma reagin were positive. The HIV component of the dual test had a sensitivity of 99.4% (95% CI, 98.4%-99.9%) and a specificity of 100% (95% CI, 99.9%-100%) when compared with the HIV testing algorithm. Conclusions Laboratory performance of the SD Bioline HIV/Syphilis Duo test was high for the HIV component of the test. Sensitivity of the treponemal component was lower than reported from most laboratory-based evaluations in the literature. However, sensitivity of the test increased substantially among patients more likely to have active syphilis for which results of both standard treponemal and nontreponemal tests were positive.
机译：背景技术双重人类免疫缺陷病毒（HIV）/梅毒快速，护理点测试可能会增强梅毒筛查，在高危人群中，增加病例发现，减少治疗时间，并防止并发症。我们评估了使用从津巴布韦性传播感染（STI）病因学研究中的患者收集的血清的快速双HIV /梅毒测试的实验室性能。方法从6中患有STI综合征的患者收集血液标本，主要是津巴布韦不同地区的城市STI诊所。所有标本在中央研究实验室测试了标准诊断生物素HIV /梅毒二重奏试验。将双发梅毒组分与串珠状血凝血凝试验（TPHA）进行比较，作为金标准比较器，单独或与非遗传试验组合，快速等离子体引发试验。将双重试验的HIV分量与在津巴布韦国家艾滋病毒检测算法后研究实验室进行的HIV快速试验的组合进行了比较。结果600名男女招收研究，436人同意血清学梅毒和艾滋病毒检测，并通过所有测定成功测试了标本。与TPHA相比，双重试验的敏感性为66.2％（95％置信区间，55.2％-77.2％）和96.4％（95％CI，94.5％-98.3％）的特异性;当TPHA和快速等离子体引发阳性时，敏感性增加到91.7％（95％CI，82.6％-99.9％）。与HIV检测算法相比，双试验的敏感性为99.4％（95％CI，95％，98.4％-99.9％）和100％（95％CI，99.9％-100％）的特异性。结论试验HIV分量的SD Bioline HIV /梅毒Duo试验的实验室性能高。在文献中的大多数基于实验室的评估中，纤维素组分的敏感性低于报道。然而，测试的敏感性大幅增加，患者更容易具有活性梅毒的患者，标准培养物和非遗传测试的结果是阳性的。

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