Mubanga Chishimba, Van Damme Inge, Trevisan Chiara, Schmidt Veronika, Phiri Isaac K, Zulu Gideon, Noh John, Handali Sukwan, Mambo Richard, Chembensofu Mwelwa, Masuku Maxwell, Reynders Dries, Jansen Famke, Bottieau Emmanuel, Magnussen Pascal, Winkler Andrea S, Dorny Pierre, Mwape Kabemba E, Gabriël Sarah
Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka 10101, Zambia.
Department of Veterinary Public Health and Food Safety, Faculty of Veterinary Medicine, Ghent University, 9820 Merelbeke, Belgium.
Diagnostics (Basel). 2021 Nov 15;11(11):2121. doi: 10.3390/diagnostics11112121.
The lack of cheap, easy-to-use, rapid diagnostic tests has led to the development of several rapid diagnostic tests for cysticercosis. The new prototype two-strip, point of care test (TS POC) detects antibodies against taeniosis (TS POC T) and cysticercosis (TS POC CC). This study evaluated the diagnostic performance of the TS POC CC in the Sinda district in eastern Zambia. A sample of 1254 participants was recruited and tested with the TS POC. Out of the 1249 participants with a valid TS POC result, 177 (14%) tested positive while 1072 (86%) tested negative. All individuals with a positive TS POC and a subset of negative TS POC participants were selected for serum sampling, and were subjected to the recombinant glycoprotein T24H enzyme-linked immunoelectrotransfer blot (rT24H EITB) and the serum B60/158 (serum Ag) enzyme-linked immunosorbent assay (Ag ELISA). Performance characteristics were estimated using a Bayesian approach with probabilistic constraints. Based on 255 complete cases, the estimated sensitivity and specificity of the TS POC CC test were 35% (95% CI: 14-63%) and 87% (95% CI: 83-90%), respectively. The diagnostic performance needs to be improved, possibly by titrating antigen and other reagents' concentration in the strip to produce a performance similar to existing cysticercosis tests such as the rT24H EITB.
缺乏廉价、易用的快速诊断测试促使人们开发了几种用于囊尾蚴病的快速诊断测试。新型双条带即时检测原型（TS POC）可检测抗绦虫病抗体（TS POC T）和抗囊尾蚴病抗体（TS POC CC）。本研究评估了TS POC CC在赞比亚东部辛达区的诊断性能。招募了1254名参与者并使用TS POC进行检测。在1249名有有效TS POC结果的参与者中，177人（14%）检测呈阳性，而1072人（86%）检测呈阴性。所有TS POC检测呈阳性的个体以及部分TS POC检测呈阴性的参与者被选取进行血清采样，并接受重组糖蛋白T24H酶联免疫电转移印迹法（rT24H EITB）和血清B60/158（血清抗原）酶联免疫吸附测定（抗原ELISA）。使用具有概率约束的贝叶斯方法估计性能特征。基于255个完整病例，TS POC CC测试的估计灵敏度和特异性分别为35%（95%置信区间：14 - 63%）和87%（95%置信区间：83 - 90%）。可能需要通过滴定试纸条中抗原和其他试剂的浓度来提高诊断性能，以使其性能类似于现有的囊尾蚴病检测方法，如rT24H EITB。
