Accuracy of individual rapid tests for serodiagnosis of gambiense sleeping sickness in West Africa.

Accuracy of individual rapid tests for serodiagnosis of gambiense sleeping sickness in West Africa.
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DOI:
10.1371/journal.pntd.0003480
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发表时间:
2015-02
影响因子:
3.8
通讯作者:
Lejon V
Lejon V
中科院分区:
医学2区
文献类型:
--
作者:
Jamonneau V;Camara O;Ilboudo H;Peylhard M;Koffi M;Sakande H;N'Dri L;Sanou D;Dama E;Camara M;Lejon V

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人非洲锥虫(HAT)的个体快速血清诊断试验(RDT)特别适用于被动筛查和监测。然而,到目前为止,还没有大规模的评价RDTs已进行诊断布氏冈比亚锥虫HAT在西非。本研究的目的是评估2种市售HAT-RDT对西非储存血浆样本的诊断准确性。对来自几内亚和科特迪瓦的722份血浆样本进行了SD Bioline HAT和HAT Sero-K-Set,其中包括231名经寄生虫学确认的HAT患者、257名健康对照和234名未经确认的个体,这些个体的血液在卡凝集试验中检测出抗体阳性,但在寄生虫学试验中检测出抗体阴性。进行免疫锥虫溶解作为锥虫特异性抗体存在的参考试验。SD Bioline HAT和HAT Sero-K-Set对HAT患者的敏感性分别为99.6%和99.1%,对健康对照的特异性分别为87.9%和88.3%。考虑到两种RDT的联合阳性,特异性显著增加(p≤0.0003)至93.4%,而灵敏度保持在98.7%。一种或两种RDT联合锥虫溶解在对照组中的特异性为98.7-99.6%,保持至少98.1%的灵敏度。观察到的单个RDT的特异性相对较低。与单一RDT相比,SD Bioline HAT和HAT Sero-K-Set的连续应用可能提供上级特异性,并保持高灵敏度。一种或两种RDT与锥虫溶解的组合似乎有望用于HAT监测。冈比亚人非洲锥虫病(HAT)或昏睡病的筛查传统上是基于血液中锥虫特异性抗体的检测。卡凝集试验特别适用于大规模筛查,而个别快速血清诊断试验则适用于外围保健中心。两个RDT最近已经商业化,我们评估了它们对西非储存血浆样本的诊断准确性。进行免疫锥虫溶解作为抗体存在的实验室参考试验。尽管两种RDT在西非HAT血清学诊断的敏感性很高,但其特异性仅为88%。考虑到大量假阳性检测结果,考虑了两种RDT中的联合血清阳性,将特异性提高至93%。因此,应考虑将连续应用两种RDT作为被动病例发现的一种选择,特别是在HAT患病率较低的情况下。一种或两种RDT与免疫锥虫溶解的组合进一步将HAT的特异性提高到99%,同时保持99%的灵敏度,似乎有望用于HAT监测。
Individual rapid tests for serodiagnosis (RDT) of human African trypanosomiasis (HAT) are particularly suited for passive screening and surveillance. However, so far, no large scale evaluation of RDTs has been performed for diagnosis of Trypanosoma brucei gambiense HAT in West Africa. The objective of this study was to assess the diagnostic accuracy of 2 commercial HAT-RDTs on stored plasma samples from West Africa. SD Bioline HAT and HAT Sero-K-Set were performed on 722 plasma samples originating from Guinea and Côte d’Ivoire, including 231 parasitologically confirmed HAT patients, 257 healthy controls, and 234 unconfirmed individuals whose blood tested antibody positive in the card agglutination test but negative by parasitological tests. Immune trypanolysis was performed as a reference test for trypanosome specific antibody presence. Sensitivities in HAT patients were respectively 99.6% for SD Bioline HAT, and 99.1% for HAT Sero-K-Set, specificities in healthy controls were respectively 87.9% and 88.3%. Considering combined positivity in both RDTs, increased the specificity significantly (p≤0.0003) to 93.4%, while 98.7% sensitivity was maintained. Specificities in controls were 98.7–99.6% for the combination of one or two RDTs with trypanolysis, maintaining a sensitivity of at least 98.1%. The observed specificity of the single RDTs was relatively low. Serial application of SD Bioline HAT and HAT Sero-K-Set might offer superior specificity compared to a single RDT, maintaining high sensitivity. The combination of one or two RDTs with trypanolysis seems promising for HAT surveillance. Screening for gambiense human African trypanosomiasis (HAT) or sleeping sickness is traditionally based on detection of trypanosome specific antibodies in blood. Whereas the card agglutination test is particularly suited for mass screening, individual rapid serodiagnostic tests (RDTs) are rather adapted for use in peripheral health-care centres. Two RDTs have been commercialized recently, and we assessed their diagnostic accuracy on stored plasma samples from West Africa. Immune trypanolysis was performed as a laboratory reference test for antibody presence. Although sensitivity for serodiagnosis of HAT in West Africa was high for both RDTs, their specificity was only 88%. Taking into account the high number of false positive test results, combined seropositivity in both RDTs was considered, raising specificity to 93%. Serial application of two RDTs should therefore be considered as an option for passive case finding, especially in settings with low HAT prevalence. A combination of one or two RDTs with immune trypanolysis further improved specificity for HAT to 99%, while maintaining sensitivity at 99% and seems promising for HAT surveillance.
DOI: 10.1371/journal.pntd.0001691
发表时间: 2012
影响因子: 3.8
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DOI: 10.1371/journal.pntd.0000917
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影响因子: 3.8
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通讯作者: Büscher P