Trial Design of a Prospective Multicenter Diagnostic Accuracy Study of a Point-of-Care Test for the Detection of Taenia solium Taeniosis and Neurocysticercosis in Hospital-Based Settings in Tanzania

Abstract

Taenia solium diagnosis is challenging as trained personnel, good diagnostic tools, and infrastructure is lacking in resource-poor areas. This paper aims to describe the study trial design adopted to evaluate a newly developed rapid point-of-care test that simultaneously detects taeniosis and neurocysticercosis (TS POC) in three district hospitals in Tanzania. The two-stage design included three types of patients: patients with specific neurological signs and symptoms (group 1); patients with complaints compatible with intestinal worm infections (group 2); patients with other symptom(s) (group 3). For group 1, all patients were tested using the TS POC test (stage 1), after which all positive, and a subset of negative, patients were selected for laboratory reference tests, clinical examination, and a brain computed tomography (CT) scan (stage 2). For groups 2 and 3, a similar design was adopted, but clinical examination and a brain CT scan (stage 2) were only performed in patients who were TS POC test-positive for cysticercosis. Due to the lack of a gold standard, a Bayesian approach was used to determine test accuracy for taeniosis and cysticercosis. For neurocysticercosis, a composite case definition was used as the reference standard. If successful, this study will help the future developments (commercialization and implementation) of the rapid test and improve patient management and disease prevention.

Epidemiological, clinical and radiological characteristics of people with neurocysticercosis in Tanzania–A cross-sectional study

“…Further details on the project’s recruitment, study procedures and diagnostic criteria can be found elsewhere. [ 17 ]…”

“…For the second comparison, only serologically positive patients were chosen, because no serologically negative patients from the OPD received a CT scan as in accordance with the study protocol. [ 17 ] Last, we also compared clinical characteristics of PWE and NCC by stage of the lesions (at least one active stage lesions versus only calcified lesions).…”

“…The protocol with the detailed study procedures has been published elsewhere. [17] A visual outline can be found in S1 Fig) . The project recruited patients with NCC typical signs/symptoms (epileptic seizures and/or history of severe progressive headache) from the Mental Health Clinic of three district hospitals (Ifisi [Mbeya rural district], Tukuyu [Mbeya rural district] and Vwawa [Mbozi district]) situated in the southern highlands of Tanzania. The screening criteria for these signs/symptoms can be found in the S1 and S2 Tables.…”

“…Further details on the project's recruitment, study procedures and diagnostic criteria can be found elsewhere. [17] This study had epidemiological, clinical and radiological objectives. The epidemiological objectives were to determine the prevalence of NCC among PWE by study site and also radiological differences between the study sites.…”

Development and evaluation of an immunochromatography-based point-of-care test kit for a rapid diagnosis of human cysticercosis

“…Recently, a point-of-care test (POCT) was developed for the detection of T. solium taeniasis and NCC in hospital-based settings ( Trevisan et al, 2021 ; Mubanga et al, 2021 ). Their prototype lateral-flow assay kit consisted of two strips and used two kinds of recombinant proteins, rT24H and rES33.…”