Evaluation of the Diagnostic Accuracy of Prototype Rapid Tests for Human African Trypanosomiasis
Evaluation of the Diagnostic Accuracy of Prototype Rapid Tests for Human African Trypanosomiasis
复制标题
DOI：
10.1371/journal.pntd.0003373
复制
发表时间：
2014-12-01
影响因子：
3.8
通讯作者：
Ndung'u, Joseph M.
中科院分区：
文献类型：
--
作者：
Sternberg, Jeremy M.;Gierlinski, Marek;Ndung'u, Joseph M.
背景资料：人类非洲锥虫病（HAT）的诊断仍然是一个挑战，无论是主动筛查，这是控制疾病的关键，并在护理点的情况下，早期和准确的诊断是至关重要的。最近，HAT的侧流快速诊断测试（RDT）“SD BIOLINE HAT”的首次现场部署已经完成。在这项研究中，我们评估了“SD BIOLINE HAT”和两种新的原型RDTs的性能。方法/主要发现：使用250例布氏冈比亚锥虫患者和250例地方病对照的存档血浆测试了“SD BIOLINE HAT”和两种原型RDTs的性能。除了比较每种器械的灵敏度和特异性外，还评估了单个抗原的性能，并外推了新型抗原组合的假设性能。在5%界值下，两种原型器械的灵敏度或特异性均不劣于“SD BIOLINE HAT”（灵敏度0.82+/-0.01，特异性0.97+/-0.01，95% CI），而其中一种器械（BBI）的灵敏度显著上级“SD BIOLINE HAT”（0.88+/-0.03）。单个抗原的性能分析用于模拟新抗原组合，以在下一代HAT RDT的开发中进行探索。模型显示，使用两种重组抗原的RDT（rLiTat 1.5和rISG 65）将提供与本研究中的最佳装置类似的性能，并且还将在恶化的现场条件下提供最稳健的性能。两者“SD BIOLINE HAT“和原型设备的性能彼此相当，也符合卡凝集试验的已公布性能范围，锥虫病的敏感性和特异性。单个抗原的性能使我们能够预测，可以开发出准确度相当于“SD BIOLINE HAT”的全重组抗原RDT。这样的RDT在简化制造、降低单位成本和保证再现性方面具有优势。
Background: Diagnosis of human African trypanosomiasis (HAT) remains a challenge both for active screening, which is critical in control of the disease, and in the point-of-care scenario where early and accurate diagnosis is essential. Recently, the first field deployment of a lateral flow rapid diagnostic test (RDT) for HAT, "SD BIOLINE HAT'' has taken place. In this study, we evaluated the performance of "SD BIOLINE HAT'' and two new prototype RDTs.Methodology/Principal Findings: The performance of "SD BIOLINE HAT'' and 2 prototype RDTs was tested using archived plasma from 250 Trypanosoma brucei gambiense patients, and 250 endemic controls. As well as comparison of the sensitivity and specificity of each device, the performance of individual antigens was assessed and the hypothetical performance of novel antigen combinations extrapolated. Neither of the prototype devices were inferior in sensitivity or specificity to "SD BIOLINE HAT'' (sensitivity 0.82+/-0.01, specificity 0.97+/-0.01, 95% CI) at the 5% margins, while one of the devices (BBI) had significantly superior sensitivity (0.88+/-0.03). Analysis of the performance of individual antigens was used to model new antigen combinations to be explored in development of the next generation of HAT RDTs. The modelling showed that an RDT using two recombinant antigens (rLiTat1.5 and rISG65) would give a performance similar to the best devices in this study, and would also offer the most robust performance under deteriorating field conditions.Conclusions/Significance: Both "SD BIOLINE HAT'' and the prototype devices performed comparably well to one another and also to the published performance range of the card agglutination test for trypanosomiasis in sensitivity and specificity. The performance of individual antigens enabled us to predict that an all-recombinant antigen RDT can be developed with an accuracy equivalent to "SD BIOLINE HAT.'' Such an RDT would have advantages in simplified manufacture, lower unit cost and assured reproducibility.