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

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

doi:10.1016/j.eclinm.2024.102893

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

EClinicalMedicine. 2024 Nov 2:77:102893. doi: 10.1016/j.eclinm.2024.102893. eCollection 2024 Nov.

Authors

Gideon Zulu^{1

2}, Dominik Stelzle^{3

4}, Kabemba E Mwape², Inge Van Damme^{5

6}, Chiara Trevisan^{5

7}, Chishimba Mubanga², Veronika Schmidt^{3

4}, Isaac K Phiri², Richard Mambo^{1

2}, Mwelwa Chembensofu², Maxwell Masuku², Charlotte Ruether³, John Noh⁸, Sukwan Handali⁸, Emmanuel Bottieau⁹, Pascal Magnussen¹⁰, Pierre Dorny⁷, Agnes Fleury¹¹, Andrea S Winkler^{3

4

12

13}, Sarah Gabriël⁵

Affiliations

¹ Ministry of Health, Lusaka, Zambia.
² Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka, Zambia.
³ Department of Neurology, School of Medicine and Health, Technical University of Munich, Munich, Germany.
⁴ Centre for Global Health, School of Medicine and Health, Technical University of Munich, Munich, Germany.
⁵ Department of Translational Physiology, Infectiology and Public Health, Faculty of Veterinary Medicine, Ghent University, Belgium.
⁶ Service of Foodborne Pathogens, Sciensano, 1050, Brussels, Belgium.
⁷ Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
⁸ Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, United States.
⁹ Department of Clinical Sciences, Institute of Tropical Medicine, 2000, Antwerp, Belgium.
¹⁰ Department of Immunology and Microbiology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
¹¹ Instituto de Investigaciones Biomédicas-UNAM/Instituto Nacional de Neurología y Neurocirugía/Facultad de Medicina-UNAM, Ciudad de México, Mexico.
¹² Department of Community Medicine and Global Health, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.
¹³ Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA.

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).

Keywords: Antigen ELISA; Diagnosis; Neurocysticercosis; Point-of-care test; Taenia solium; rT24H-EITB.