The performance of a point-of-care test for the diagnosis of Neurocysticercosis in a resource-poor community setting in Zambia - a diagnostic accuracy study.

IF 9.6 1区医学 Q1 MEDICINE, GENERAL & INTERNAL EClinicalMedicine Pub Date : 2024-11-02 eCollection Date: 2024-11-01 DOI:10.1016/j.eclinm.2024.102893

Gideon Zulu, Dominik Stelzle, Kabemba E Mwape, Inge Van Damme, Chiara Trevisan, Chishimba Mubanga, Veronika Schmidt, Isaac K Phiri, Richard Mambo, Mwelwa Chembensofu, Maxwell Masuku, Charlotte Ruether, John Noh, Sukwan Handali, Emmanuel Bottieau, Pascal Magnussen, Pierre Dorny, Agnes Fleury, Andrea S Winkler, Sarah Gabriël

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Abstract

Background: Neurocysticercosis (NCC) is the main cause of epilepsy in Taenia solium endemic rural communities. NCC diagnosis is difficult due to unavailability and unaffordability of serologic assays and neuroimaging. This study aimed to assess the performance of a cheap, novel T. solium lateral-flow point-of-care (TS POC) test for the diagnosis of NCC in a community setting.

Methods: A diagnostic accuracy study with prospective data collection, using a two-stage design was conducted in Sinda district of the Eastern province of Zambia between December 2017 and June 2019. Eligible participants were tested with the TS POC test. Thereafter, participants with a TS POC CC+ result and a subset of participants with a TS POC CC- result were subjected to serological testing for reference assays, and cerebral computed tomography (CT) for the reference diagnosis of NCC.

Findings: A total of 1249 participants were tested with the TS POC of which 177 (14%) were positive. Of the 151 TS POC CC+ and 82 TS POC CC- participants with cerebral CT examination, 35 TS POC CC+ and 10 TS POC CC-, respectively, had NCC. The sensitivity of the TS POC CC strip was 26% (uncertainty interval [UI] 15-41) for any type of NCC, which was similar to that estimated for the rT24H-EITB (23%, UI 8-48) and the serum antigen ELISA (30%, UI 11-58). The specificity was 88% (UI 85-90) for the TS POC, 89% (UI 79-94) for the rT24H-EITB, and 82% (UI 71-89) for the antigen ELISA. For NCC with active stage lesions, sensitivity was >99% (UI 58->99) for the TS POC, 76% (UI 40-94) for the rT24H-EITB and 76% (UI 39-94) for the antigen ELISA.

Interpretation: The TS POC CC had a promising sensitivity for diagnosis of participants with active NCC lesions within a community-based setting. Accuracy for NCC at any stage was limited for all tests (TS POC, rT24H-EITB and antigen ELISA). With further development the TS POC CC may enable a better detection and faster referral of NCC patients who may benefit from antiparasitic treatment.

Funding: European and Developing Countries Clinical Trials Partnership (EDCTP) and the German Federal Ministry of Education and Research (BMBF).

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在赞比亚一个资源匮乏的社区环境中，用于诊断神经囊尾蚴病的护理点检验的性能--诊断准确性研究。

背景：神经囊尾蚴病（NCC）是疟原虫流行的农村社区癫痫的主要病因。由于血清学检测和神经影像学检测的缺乏和价格昂贵，NCC的诊断十分困难。本研究旨在评估一种廉价、新型的T.solium横向流动护理点检测（TS POC）在社区环境中诊断NCC的性能：2017年12月至2019年6月期间，在赞比亚东部省辛达地区开展了一项前瞻性数据收集诊断准确性研究，采用两阶段设计。符合条件的参与者接受了 TS POC 测试。之后，对 TS POC CC+ 结果的参与者和 TS POC CC- 结果的参与者子集进行血清学检测，以获得参考测定结果，并进行脑计算机断层扫描（CT），以获得 NCC 的参考诊断结果：共有 1249 人接受了 TS POC 检测，其中 177 人（14%）呈阳性。在接受脑CT检查的151名TS POC CC+和82名TS POC CC-参与者中，分别有35名TS POC CC+和10名TS POC CC-患者患有NCC。TS POC CC条对任何类型NCC的灵敏度为26%（不确定区间[UI] 15-41），与rT24H-EITB（23%，UI 8-48）和血清抗原ELISA（30%，UI 11-58）的估计值相似。TS POC 的特异性为 88%（UI 85-90），rT24H-EITB 为 89%（UI 79-94），抗原 ELISA 为 82%（UI 71-89）。对于有活动期病变的 NCC，TS POC 的灵敏度大于 99%（UI 58->99），rT24H-EITB 为 76%（UI 40-94），抗原 ELISA 为 76%（UI 39-94）：在社区环境中，TS POC CC 对活动性 NCC 病变参与者的诊断灵敏度很高。所有测试（TS POC、rT24H-EITB 和抗原 ELISA）对任何阶段的 NCC 的准确性都有限。随着TS POC CC的进一步发展，它可以更好地检测NCC患者，并更快地将其转诊，使其从抗寄生虫治疗中获益：欧洲与发展中国家临床试验合作组织（EDCTP）和德国联邦教育与研究部（BMBF）。

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来源期刊

EClinicalMedicine Medicine-Medicine (all)

CiteScore

18.90

自引率

1.30%

发文量

506

审稿时长

22 days

期刊介绍： eClinicalMedicine is a gold open-access clinical journal designed to support frontline health professionals in addressing the complex and rapid health transitions affecting societies globally. The journal aims to assist practitioners in overcoming healthcare challenges across diverse communities, spanning diagnosis, treatment, prevention, and health promotion. Integrating disciplines from various specialties and life stages, it seeks to enhance health systems as fundamental institutions within societies. With a forward-thinking approach, eClinicalMedicine aims to redefine the future of healthcare.