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Contributions to the improvement and understanding of new diagnostics for HIV infection and syphilis.

机译：有助于改善和了解艾滋病毒感染和梅毒的新诊断方法。

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摘要

Syphilis is a curable disease, yet 10 million persons worldwide are infected each year, of which 1.4 million are pregnant women. Syphilis is an infection caused by the spirochete Treponema pallidum and frequently has atypical presentations that may be difficult to differentiate from other sexually transmitted infections (STIs) making effective diagnostics essential to the identification of infection. Additionally, the manifestations of the disease vary depending on the duration of infection and time of presentation. There are four stages-primary, secondary, latent (early and late), and tertiary.;Syphilis screening and treatment programs that utilize laboratory-based testing have been hampered by limited laboratory access, long turn-around time for results, and loss to follow-up of syphilis infected individuals. When syphilis diagnostic testing involves multiple tests performed off-site, only a proportion of infected individuals receive treatment and continued transmission occurs. A rapid test is a simple point-of-care test that can be used in a variety of settings and provides a result to guide clinical management during the time of the initial consultation (ideally within 30 minutes or less). The advent of rapid point-of-care tests for syphilis has reduced barriers and allowed for new health systems approaches to syphilis prevention, including same day testing and treatment. Dual rapid tests that have multiple analytes for the detection of antibodies for both HIV and syphilis infections are now available. Our first study addressed preferences for dual HIV/syphilis tests through a conjoint survey analysis. Conjoint analysis is a method for systematically estimating consumer preferences across discrete attributes. Conjoint analysis has been used extensively in marketing research and measures the value that consumers place on each feature of a product. Conjoint analysis has recently begun to be applied in health research. We recruited 298 men and women 18 years of age and over seeking testing or care at GHESKIO (Haitian Study Group for Kaposi's sarcoma and Opportunistic Infections) clinics. We created 8 hypothetical dual test profiles varying across six dichotomous attributes: cost (free versus ;Our second study was a field study of a dual HIV and syphilis rapid test in Port-au-Prince, Haiti. Field studies using whole blood fingerprick specimens are essential to understand how the test will perform in real-world settings. We found that for the HIV test component, sensitivity and specificity were 99.2% (95% CI: 95.8%, 100%) and 97.0% (95% CI: 93.2%, 99.0%), respectively; and for the syphilis component were 96.5% (95% CI: 91.2%, 99.0%) and 90.8% (95% CI: 85.7%, 94.6%), respectively. This test performed well and could be considered for wider use to increase rates of HIV and syphilis screening.;Our final analysis was an epidemiological bias analysis using estimates of potential misclassification by use of an imperfect gold standard test. We used regression calibration methods to assess the effect of reference standard misclassification bias using the syphilis component of the dual HIV and syphilis rapid test as an example. We concluded by making recommendations for reporting diagnostic performance ranges instead of point estimates when using an imperfect reference test. In conclusion, dual HIV and syphilis testing is a preferred screening modality that can be used to streamline HIV and syphilis prevention and case finding. These tests perform well in both laboratory and point-of-care settings and should be considered for wider implementation. Use of regression calibration methodology can provide accurate information on the potential performance characteristics of these tests when a perfect gold standard test is unavailable.
机译：梅毒是可以治愈的疾病，但是，全世界每年有1000万人受到感染，其中140万人是孕妇。梅毒是由螺旋体螺旋体梅毒螺旋体引起的感染，通常具有非典型表现，可能难以与其他性传播感染（STI）区分开，从而使有效的诊断对于识别感染至关重要。另外，疾病的表现取决于感染的持续时间和表现时间。主要分为四个阶段：主要阶段，次要阶段，潜伏阶段（早期和晚期）和第三阶段；利用实验室测试的梅毒筛查和治疗程序由于实验室访问受限，结果周转时间长以及结果丢失而受到阻碍。梅毒感染者的随访。当梅毒诊断测试涉及异地执行的多项测试时，只有一部分感染者会接受治疗，并且会继续传播。快速测试是一种简单的即时检验，可以在多种环境中使用，并提供结果指导初次咨询时（最好在30分钟或更短时间内）指导临床管理。梅毒快速即时检测的出现减少了障碍，并允许采取新的卫生系统预防梅毒的方法，包括当日检测和治疗。现在可以使用具有多种分析物的双重快速测试来检测针对HIV和梅毒感染的抗体。我们的第一项研究通过联合调查分析解决了艾滋病毒/梅毒双重检测的偏爱。联合分析是一种系统地评估离散属性中消费者偏好的方法。联合分析已广泛用于营销研究，并衡量了消费者对产品每个功能的重视程度。联合分析最近已开始在健康研究中应用。我们招募了298名18岁以上的男性和女性，他们希望在GHESKIO（卡波西肉瘤和机会性感染海地研究小组）诊所进行检查或护理。我们创建了8个假想的双重测试配置文件，这些测试变化了六个二分属性：成本（免费与否；我们的第二项研究是在海地太子港进行的HIV和梅毒双重快速测试的现场研究。这对于了解该测试在实际环境中的性能至关重要。我们发现，对于HIV测试成分，敏感性和特异性分别为99.2％（95％CI：95.8％，100％）和97.0％（95％CI：93.2％） ，分别为99.0％）和梅毒成分分别为96.5％（95％CI：91.2％，99.0％）和90.8％（95％CI：85.7％，94.6％）。我们的最终分析是一种流行病学偏差分析，使用不完善的金标准测试对潜在错误分类的估计，我们使用回归校准方法评估参考标准错误分类偏差的效果使用梅毒的以HIV和梅毒双重快速检测为例。最后，我们提出了使用不完善的参考测试时建议报告诊断性能范围而不是点估计的建议。总之，艾滋病毒和梅毒双重检测是一种首选的筛查方式，可用于简化艾滋病毒和梅毒的预防和病例发现。这些测试在实验室和现场护理环境中均表现良好，应考虑更广泛地实施。当没有完美的金标准测试时，使用回归校准方法可以提供有关这些测试潜在性能特征的准确信息。

著录项

  • 作者

    Bristow, Claire Catherine.;

  • 作者单位

    University of California, Los Angeles.;

  • 授予单位 University of California, Los Angeles.;
  • 学科 Epidemiology.
  • 学位 Ph.D.
  • 年度 2015
  • 页码 80 p.
  • 总页数 80
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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