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

被引:7
|
作者
Trevisan, Chiara [1 ,2 ]
Damme, Inge [2 ]
Ngowi, Bernard [3 ,4 ]
Schmidt, Veronika [5 ,6 ]
Stelzle, Dominik [5 ,7 ]
Moller, Karen [8 ]
Kabululu, Mwemezi [9 ]
Makasi, Charles [3 ]
Magnussen, Pascal [10 ]
Bottieau, Emmanuel [11 ]
Abatih, Emmanuel [12 ]
Johansen, Maria
Ngowi, Helena [13 ]
Ndawi, Benedict [14 ]
Mwape, Kabemba [15 ]
Zulu, Gideon [15 ,16 ]
Dorny, Pierre [5 ,6 ]
Winkler, Andrea [2 ]
Gabriel, Sarah [2 ]
机构
[1] Inst Trop Med, Dept Biomed Sci, B-2000 Antwerp, Belgium
[2] Univ Ghent, Fac Vet Med, Dept Vet Publ Hlth & Food Safety, B-9820 Merelbeke, Belgium
[3] Natl Inst Med Res, Muhimbili Med Res Ctr Dar es Salaam, Dar Es Salaam 11101, Tanzania
[4] Univ Dar es Salaam Tanzania, Dept Publ Hlth, Dar Es Salaam 65015, Tanzania
[5] Tech Univ Munich, Ctr Global Hlth, Dept Neurol, Klinikum Rechts Isar, D-81675 Munich, Germany
[6] Univ Oslo, Fac Med, Ctr Global Hlth, Inst Hlth & Soc, N-0450 Oslo, Norway
[7] Tech Univ Munich, Dept Sport & Hlth Sci, Chair Epidemiol, D-80809 Munich, Germany
[8] Univ Copenhagen, Fac Hlth & Med Sci, Dept Vet & Anim Sci, DK-1870 Frederiksberg, Denmark
[9] Tanzania Livestock Res Inst TALIRI Uyole, POB 6191, Mbeya, Tanzania
[10] Univ Copenhagen, Fac Hlth & Med Sci, DK-2200 Copenhagen, Denmark
[11] Inst Trop Med, Dept Clin Sci, B-2000 Antwerp, Belgium
[12] Univ Ghent, Fac Sci, Dept Appl Math Comp Sci & Stat, B-9000 Ghent, Belgium
[13] Sokoine Univ Agr, Coll Vet Med & Biomed Sci, Dept Vet Med & Publ Hlth, POB 3021, Morogoro, Tanzania
[14] Primary Hlth Care Inst, Iringa 235, Tanzania
[15] Univ Zambia, Sch Vet Med, Dept Clin Studies, Lusaka 10101, Zambia
[16] Minist Hlth, Eastern Prov Hlth Off, Lusaka 30205, Zambia
关键词
Taenia solium; taeniosis; cysticercosis; hospital-based settings; point-of-care test; rapid tests; diagnostics; CYSTICERCOSIS; PREVALENCE; EPILEPSY; IMMUNODIAGNOSIS; ANTIGENS; CLONING;
D O I
10.3390/diagnostics11091528
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
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页数:13
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