Evaluation of a point-of-care test for the diagnosis of Taenia solium neurocysticercosis in rural southern Tanzania: a diagnostic accuracy study

Dominik Stelzle; Charles E Makasi; Veronika Schmidt; Inge Van Damme; Chiara Trevisan; Charlotte Ruether; Agnès Fleury; John Noh; Sukwan Handali; Pierre Dorny; Pascal Magnussen; Gideon Zulu; Kabemba E Mwape; Emmanuel Bottieau; Sarah Gabriël; Bernard J Ngowi; Andrea S Winkler; SOLID collaborators

doi:10.1016/S1473-3099(23)00378-X

Evaluation of a point-of-care test for the diagnosis of Taenia solium neurocysticercosis in rural southern Tanzania: a diagnostic accuracy study

Lancet Infect Dis. 2024 Jan;24(1):98-106. doi: 10.1016/S1473-3099(23)00378-X. Epub 2023 Aug 31.

Authors

Dominik Stelzle¹, Charles E Makasi², Veronika Schmidt³, Inge Van Damme⁴, Chiara Trevisan⁵, Charlotte Ruether⁶, Agnès Fleury⁷, John Noh⁸, Sukwan Handali⁸, Pierre Dorny⁹, Pascal Magnussen¹⁰, Gideon Zulu¹¹, Kabemba E Mwape¹², Emmanuel Bottieau¹³, Sarah Gabriël⁴, Bernard J Ngowi¹⁴, Andrea S Winkler¹⁵; SOLID collaborators

Collaborators

SOLID collaborators:
Chishala Chabala, Chishimba Mubanga, Famke Jansen, Isaac K Phiri, Richard Mambo

Affiliations

¹ Department of Neurology, Center for Global Health, Faculty of Medicine, Technical University of Munich, Munich, Germany. Electronic address: dominik.stelzle@tum.de.
² National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania; Kilimanjaro Christian Medical University, College of Tumaini University, Moshi, Tanzania.
³ Department of Neurology, Center for Global Health, Faculty of Medicine, Technical University of Munich, Munich, Germany.
⁴ Department of Translational Physiology, Infectiology, and Public Health, Faculty of Veterinary Medicine, Ghent University, Ghent, Belgium.
⁵ Department of Translational Physiology, Infectiology, and Public Health, Faculty of Veterinary Medicine, Ghent University, Ghent, Belgium; Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
⁶ Department of Neuroradiology, RoMed Clinic Rosenheim, Rosenheim, Germany.
⁷ Department of Genomic Medicine and Environmental Toxicology, Instituto de Investigaciones Biomédicas - UNAM, Ciudad de México, Mexico; Neurocysticercosis Clinic, Instituto Nacional de Neurología y Neurocirugía, Ciudad de México, México.
⁸ Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention, Atlanta, GA, USA.
⁹ Department of Biomedical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
¹⁰ Department of Microbiology and Immunology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
¹¹ Ministry of Health, Lusaka, Zambia.
¹² Department of Clinical Studies, School of Veterinary Medicine, University of Zambia, Lusaka, Zambia.
¹³ Department of Clinical Sciences, Institute of Tropical Medicine, Antwerp, Belgium.
¹⁴ National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania; Mbeya College of Health and Allied Sciences, University of Dar es Salaam, Mbeya, Tanzania.
¹⁵ Department of Neurology, Center for Global Health, Faculty of Medicine, Technical University of Munich, Munich, Germany; Department of Community Medicine and Global Health, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA. Electronic address: andrea.winkler@tum.de.

PMID: 37660709
DOI: 10.1016/S1473-3099(23)00378-X

Abstract

Background: Neurocysticercosis is a common cause of epilepsy in Taenia solium-endemic areas in sub-Saharan Africa but is often undiagnosed because of an absence of affordable diagnostic tools. This study evaluated the diagnostic accuracy of a T solium cysticercosis antibody-detecting lateral-flow point-of-care assay (TS POC test) for the neuroimaging-based diagnosis of neurocysticercosis.

Methods: Patients with epileptic seizures or severe progressive headache were recruited consecutively from three hospitals in southern Tanzania. All patients were tested with the TS POC test. All patients positive for cysticercosis on the TS POC test and every tenth patient who was negative for cysticercosis received a brain CT examination and underwent reference testing for T solium cysticercosis (ie, rT24H-EITB, LLGP-EITB, and antigen ELISA). The primary outcome of the study was the sensitivity of the TS POC test for the diagnosis of neurocysticercosis.

Findings: Of the 601 recruited participants, 102 (17%) tested positive for cysticercosis with the TS POC test. Overall, 48 (62%) of the 77 patients positive for cysticercosis and five (17%) of the 29 patients negative for cysticercosis on the TS POC test had CT-confirmed neurocysticercosis. The TS POC test yielded a sensitivity of 49% (uncertainty interval [UI] 41-58) for neurocysticercosis. Sensitivity was similar to that of the rT24H-EITB (44%, UI 37-51) and the antigen ELISA (50%, 43-56). For the subset of neurocysticercosis cases with at least one active (ie, vesicular) lesion, sensitivity was above 98% for the TS POC test, the rT24H-ETIB, and the antigen ELISA.

Interpretation: The TS POC test showed promising results for the diagnosis of neurocysticercosis in patients with vesicular lesions, which need to be confirmed in a larger study. This test could be considered to support policies on screening patients with suspected neurocysticercosis in clinical settings, which would allow appropriate referral for neuroimaging and early treatment.

Funding: German Federal Ministry of Education and Research and the European & Developing Countries Clinical Trials Partnership.

Translation: For the Swahili translation of the abstract see Supplementary Materials section.

MeSH terms

Animals
Cysticercosis* / diagnosis
Epilepsy*
Humans
Neurocysticercosis* / diagnosis
Point-of-Care Testing
Taenia solium*
Tanzania