Programme National de Lutte contre la Trypanosomiase Humaine Africaine, Kinshasa, Democratic Republic of the Congo.
Global Health Institute, University of Antwerp, Antwerp, Belgium.
PLoS Negl Trop Dis. 2018 Mar 28;12(3):e0006386. doi: 10.1371/journal.pntd.0006386. eCollection 2018 Mar.
Diagnosis and treatment are central elements of strategies to control Trypanosoma brucei gambiense human African trypanosomiasis (HAT). Serological screening is a key entry point in diagnostic algorithms. The Card Agglutination Test for Trypanosomiasis (CATT) has been the most widely used screening test for decades, despite a number of practical limitations that were partially addressed by the introduction of rapid diagnostic tests (RDTs). However, current RDTs are manufactured using native antigens, which are challenging to produce.
METHODOLOGY/PRINCIPAL FINDINGS: The objective of this study was to evaluate the accuracy of a new RDT developed using recombinant antigens (SD BIOLINE HAT 2.0), in comparison with an RDT produced using native antigens (SD BIOLINE HAT) and CATT. A total of 57,632 individuals were screened in the Democratic Republic of the Congo, either passively at 10 health centres, or actively by 5 mobile teams, and 260 HAT cases were confirmed by parasitology. The highest sensitivity was achieved with the SD BIOLINE HAT 2.0 (71.2%), followed by CATT (62.5%) and the SD BIOLINE HAT (59.0%). The most specific test was CATT (99.2%), while the specificity of the SD BIOLINE HAT and SD BIOLINE HAT 2.0 were 98.9% and 98.1%, respectively. Sensitivity of the tests was lower than previously reported, as they identified cases from partially overlapping sub-populations. All three tests were significantly more sensitive in passive than in active screening. Combining two or three tests resulted in a markedly increased sensitivity: When the SD BIOLINE HAT was combined with the SD BIOLINE HAT 2.0, sensitivity reached 98.4% in passive and 83.0% in active screening.
CONCLUSIONS/SIGNIFICANCE: The recombinant antigen-based RDT was more sensitive than, and as specific as, the SD BIOLINE HAT. It was as sensitive as, but slightly less specific than CATT. While the practicality and cost-effectiveness of algorithms including several screening tests would need to be investigated, using two or more tests appears to enhance sensitivity of diagnostic algorithms, although some decrease in specificity is observed as well.
诊断和治疗是控制布氏冈比亚锥虫人体非洲锥虫病（HAT）策略的核心要素。血清学筛查是诊断算法的关键切入点。卡 Agglutination 检测 for 锥虫病（CATT）几十年来一直是最广泛使用的筛查试验，尽管引入快速诊断试验（RDT）部分解决了一些实际限制。然而，目前的 RDT 是使用天然抗原制造的，这些抗原的生产具有挑战性。
方法/主要发现：本研究的目的是评估使用重组抗原（SD BIOLINE HAT 2.0）开发的新 RDT 的准确性，与使用天然抗原（SD BIOLINE HAT）和 CATT 生产的 RDT 进行比较。在刚果民主共和国，共有 57632 人接受了筛查，要么在 10 个卫生中心被动筛查，要么由 5 个流动小组主动筛查，并通过寄生虫学确认了 260 例 HAT 病例。SD BIOLINE HAT 2.0 的敏感性最高（71.2%），其次是 CATT（62.5%）和 SD BIOLINE HAT（59.0%）。最特异的试验是 CATT（99.2%），而 SD BIOLINE HAT 和 SD BIOLINE HAT 2.0 的特异性分别为 98.9%和 98.1%。由于它们鉴定了部分重叠亚群的病例，因此这些测试的敏感性低于之前的报道。在被动筛查中，所有三种测试的敏感性均明显高于主动筛查。将两种或三种测试结合使用可显著提高敏感性：当将 SD BIOLINE HAT 与 SD BIOLINE HAT 2.0 结合使用时，在被动筛查中的敏感性达到 98.4%，在主动筛查中的敏感性达到 83.0%。
结论/意义：基于重组抗原的 RDT 比 SD BIOLINE HAT 更敏感，特异性也相同。它与 CATT 一样敏感，但特异性略低。虽然需要研究包括几种筛查试验的算法的实用性和成本效益，但使用两种或更多测试似乎可以提高诊断算法的敏感性，尽管特异性也会略有下降。
