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.
Highlights
Taenia solium is a neglected zoonotic parasite contributing to the significant health and economic burden in affected areas of low- and middle-income countries (LMIC) [1].In Tanzania, several projects on T. solium cysticercosis have been conducted and provided evidence of the parasite presence in several regions of the country [2]
As unblinded studies may have a higher sensitivity and overall accuracy of results when the person interpreting the reference standard is aware of the index test result [25], diagnostic review bias in the present study was avoided by blinding all laboratory technicians to the TS POC test result
As the interpretation of several reference test results for T and CC have inherent test integrity, diagnostic review bias seemed very unlikely for the evaluation of T and CC
Summary
Taenia solium is a neglected zoonotic parasite contributing to the significant health and economic burden in affected areas of low- and middle-income countries (LMIC) [1].In Tanzania, several projects on T. solium cysticercosis have been conducted and provided evidence of the parasite presence in several regions of the country [2]. Taenia solium is a neglected zoonotic parasite contributing to the significant health and economic burden in affected areas of low- and middle-income countries (LMIC) [1]. At the district hospital level, the diagnosis of tapeworms can be performed using microscopy, but has a low sensitivity and fails to differentiate Taenia spp. Other methods, such as the copro-antigen ELISA, the recombinant antigen-based enzyme-linked immunoelectrotransfer blot (EITB), and polymerase chain reaction (PCR) techniques are available and have limitations in their performance, and are used only in research settings as laboratories at the district hospital level in Tanzania lack equipment, adequately trained experts, and infrastructure [6]. Differential diagnosis and the stigma associated with epilepsy further contribute to the challenges that district hospitals face [7]
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