TY - JOUR

T1 - 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

AU - Trevisan, Chiara

AU - Van Damme, Inge

AU - Ngowi, Bernard

AU - Schmidt, Veronika

AU - Stelzle, Dominik

AU - Møller, Karen Schou

AU - Kabululu, Mwemezi

AU - Makasi, Charles E.

AU - Magnussen, Pascal

AU - Bottieau, Emmanuel

AU - Abatih, Emmanuel

AU - Johansen, Maria V.

AU - Ngowi, Helena

AU - Ndawi, Benedict

AU - Mwape, Kabemba E.

AU - Zulu, Gideon

AU - Dorny, Pierre

AU - Winkler, Andrea S.

AU - Gabriël, Sarah

AU - SOLID Consortium

N1 - Publisher Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Cysticercosis

KW - Diagnostics

KW - Hospital-based settings

KW - Point-of-care test

KW - Rapid tests

KW - Taenia solium

KW - Taeniosis

U2 - 10.3390/diagnostics11091528

DO - 10.3390/diagnostics11091528

M3 - Journal article

C2 - 34573870

AN - SCOPUS:85114098509

VL - 11

JO - Diagnostics

JF - Diagnostics

SN - 2075-4418

IS - 9

M1 - 1528

ER -