BACKGROUND Little is known about the diagnostic performance of rapid diagnostic tests (RDTs) for passive screening of human African trypanosomiasis (HAT) in Côte d'Ivoire. We determined HAT prevalence among clinical suspects, identified clinical symptoms and signs associated with HAT RDT positivity, and assessed the diagnostic tests' specificity, positive predictive value and agreement. METHODS Clinical suspects were screened with SD Bioline HAT, HAT Sero-K-Set and rHAT Sero-Strip. Seropositives were parasitologically examined, and their dried blood spots tested in trypanolysis, ELISA/Tbg, m18S-qPCR and LAMP. The HAT prevalence in the study population was calculated based on RDT positivity followed by parasitological confirmation. The association between clinical symptoms and signs and RDT positivity was determined using multivariable logistic regression. The tests' Positive Predictive Value (PPV), specificity and agreement were determined. RESULTS Over 29 months, 3433 clinical suspects were tested. The RDT positivity rate was 2.83%, HAT prevalence 0.06%. Individuals with sleep disturbances (p<0.001), motor disorders (p = 0.002), convulsions (p = 0.02), severe weight loss (p = 0.02) or psychiatric problems (p = 0.04) had an increased odds (odds ratios 1.7-4.6) of being HAT RDT seropositive. Specificities ranged between 97.8%-99.6% for individual RDTs, and 93.3-98.9% for subsequent tests on dried blood spots. The PPV of the individual RDTs was below 14.3% (CI 2-43), increased to 33.3% (CI 4-78) for serial RDT combinations, and reached 67% for LAMP and ELISA/Tbg on RDT positives. Agreement between diagnostic tests was poor to moderate (Kappa ≤ 0.60), except for LAMP and ELISA/Tbg (Kappa = 0.66). CONCLUSION Identification of five key clinical symptoms and signs may simplify referral for HAT RDT screening. The results confirm the appropriateness of the diagnostic algorithm presently applied, with screening by SD Bioline HAT or HAT Sero-K-Set, supplemented with trypanolysis. ELISA/Tbg could replace trypanolysis and is simpler to perform. TRIAL REGISTRATION ClinicalTrials.gov NCT03356665.

中文翻译：

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科特迪瓦非洲人类锥虫病的被动监测：了解流行率、临床症状和体征以及诊断测试特征。

背景 对于科特迪瓦人类非洲锥虫病 (HAT) 被动筛查的快速诊断测试 (RDT) 的诊断性能知之甚少。我们确定了临床嫌疑人中 HAT 的患病率，确定了与 HAT RDT 阳性相关的临床症状和体征，并评估了诊断测试的特异性、阳性预测值和一致性。方法 使用 SD Bioline HAT、HAT Sero-K-Set 和 rHAT Sero-Strip 筛查临床疑似病例。对血清阳性者进行寄生虫学检查，并在锥虫病、ELISA/Tbg、m18S-qPCR 和 LAMP 中测试其干血斑。研究人群中的 HAT 流行率是根据 RDT 阳性和寄生虫学确认计算的。使用多变量逻辑回归确定临床症状和体征与 RDT 阳性之间的关联。确定了测试的阳性预测值 (PPV)、特异性和一致性。结果 在 29 个月内，对 3433 名临床疑似患者进行了测试。RDT 阳性率为 2.83%，HAT 患病率为 0.06%。有睡眠障碍 (p<0.001)、运动障碍 (p = 0.002)、抽搐 (p = 0.02)、严重体重减轻 (p = 0.02) 或精神问题 (p = 0.04) 的个体的比值增加（比值比 1.7- 4.6) HAT RDT 血清阳性。个别 RDT 的特异性介于 97.8%-99.6% 之间，随后对干血斑的检测特异性介于 93.3-98.9% 之间。单个 RDT 的 PPV 低于 14.3% (CI 2-43)，连续 RDT 组合增加到 33.3% (CI 4-78)，LAMP 和 ELISA/Tbg 的 RDT 阳性率达到 67%。除了 LAMP 和 ELISA/Tbg（Kappa = 0.66）外，诊断测试之间的一致性差到中等（Kappa ≤ 0.60）。结论 确定五个关键的临床症状和体征可以简化 HAT RDT 筛查的转诊。结果证实了目前应用的诊断算法的适当性，通过 SD Bioline HAT 或 HAT Sero-K-Set 进行筛选，并辅以锥虫病。ELISA/Tbg 可以替代锥虫病，而且操作更简单。试验注册 ClinicalTrials.gov NCT03356665。结果证实了目前应用的诊断算法的适当性，通过 SD Bioline HAT 或 HAT Sero-K-Set 进行筛选，并辅以锥虫病。ELISA/Tbg 可以替代锥虫病，而且操作更简单。试验注册 ClinicalTrials.gov NCT03356665。结果证实了目前应用的诊断算法的适当性，通过 SD Bioline HAT 或 HAT Sero-K-Set 进行筛选，并辅以锥虫病。ELISA/Tbg 可以替代锥虫病，而且操作更简单。试验注册 ClinicalTrials.gov NCT03356665。