Trypanosoma brucei gambiense-iELISA: A Promising New Test for the Post-Elimination Monitoring of Human African Trypanosomiasis.

Trypanosoma brucei gambiense-iELISA: A Promising New Test for the Post-Elimination Monitoring of Human African Trypanosomiasis.
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DOI:
10.1093/cid/ciaa1264
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发表时间:
2021-11-02
期刊:
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子:
--
通讯作者:
Büscher P
Büscher P
中科院分区:
其他
文献类型:
--
作者:
Geerts M;Van Reet N;Leyten S;Berghmans R;Rock KS;Coetzer THT;Eyssen LE;Büscher P

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世界卫生组织将消除布氏冈比亚人类非洲锥虫病作为一个公共卫生问题和消除传播的目标。要在流行率接近于零的情况下衡量消除gHAT的成功程度,必须进行高度特异性的诊断。这种测试以抗体介导的补体溶解测试,锥虫溶解测试的形式存在,但生物安全问题和技术要求阻碍了其大规模使用。我们开发了一种具有高特异性和敏感性的抑制酶联免疫吸附试验,适用于gHAT流行国家的区域实验室。冈比亚锥虫抑制ELISA (g-iELISA)是基于单克隆抗体与冈比亚锥虫表面糖蛋白特异性表位的结合可以被gHAT患者针对相同表位的循环抗体所抑制的原理。以锥虫酶解作为参考试验,对739例gHAT患者和619例地方病对照者的血浆样本以及95例gHAT患者和37例地方病对照者的血浆制备的干血点进行了g-iELISA诊断准确性评估。血浆的总体敏感性和特异性分别为98.0% (95% CI 96.7-98.9)和99.5% (95% CI 98.6-99.9)。对于干血斑,敏感性为92.6% (95% CI 85.4-97.0),特异性为100% (95% CI 90.5-100.0)。g-iELISA在2-8°C下保存至少8个月。g-iELISA可能在很大程度上取代锥虫酶解用于监测gHAT消除和消除后监测。g-iELISA试剂盒可在流行国家的参考实验室进行评估。新型布氏锥虫冈比亚锥虫抑制ELISA (g-iELISA)是一种高通量诊断方法,适用于区域实验室监测冈比亚锥虫- hat的消除。血浆样品的敏感性为98.0%,特异性为99.5%;干血斑的敏感性为92.6%,特异性为100%。
The World Health Organization targeted Trypanosoma brucei gambiense human African trypanosomiasis (gHAT) for elimination as a public health problem and for elimination of transmission. To measure gHAT elimination success with prevalences close to zero, highly specific diagnostics are necessary. Such a test exists in the form of an antibody-mediated complement lysis test, the trypanolysis test, but biosafety issues and technological requirements prevent its large-scale use. We developed an inhibition ELISA with high specificity and sensitivity that is applicable in regional laboratories in gHAT endemic countries. The T. b. gambiense inhibition ELISA (g-iELISA) is based on the principle that binding of monoclonal antibodies to specific epitopes of T. b. gambiense surface glycoproteins can be inhibited by circulating antibodies of gHAT patients directed against the same epitopes. Using trypanolysis as reference test, the diagnostic accuracy of the g-iELISA was evaluated on plasma samples from 739 gHAT patients and 619 endemic controls and on dried blood spots prepared with plasma of 95 gHAT and 37 endemic controls. Overall sensitivity and specificity on plasma were, respectively, 98.0% (95% CI 96.7–98.9) and 99.5% (95% CI 98.6–99.9). With dried blood spots, sensitivity was 92.6% (95% CI 85.4–97.0), and specificity was 100% (95% CI 90.5–100.0). The g-iELISA is stable for at least 8 months when stored at 2–8°C. The g-iELISA might largely replace trypanolysis for monitoring gHAT elimination and for postelimination surveillance. The g-iELISA kit is available for evaluation in reference laboratories in endemic countries. The novel Trypanosoma brucei gambiense inhibition ELISA (g-iELISA) is a high-throughput diagnostic applicable in regional laboratories for monitoring gambiense-HAT elimination. On plasma samples, sensitivity was 98.0% and specificity 99.5%, while on dried blood spots sensitivity was 92.6% and specificity 100%.
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