A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo
| العنوان: | A Phase III Diagnostic Accuracy Study of a Rapid Diagnostic Test for Diagnosis of Second-Stage Human African Trypanosomiasis in the Democratic Republic of the Congo |
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| المؤلفون: | Emmanuel Bottieau, Philippe Gillet, Kristien Verdonck, Marleen Boelaert, Luigi Minikulu, Pascal Lutumba, Jean Roger Kalo Lilo, Cedric P. Yansouni, Deby Mukendi, François Chappuis, Barbara Barbé |
| المصدر: | EBioMedicine, Vol 27, Iss C, Pp 11-17 (2018) EBioMedicine |
| بيانات النشر: | Elsevier, 2018. |
| سنة النشر: | 2018 |
| مصطلحات موضوعية: | Adult, Male, Pediatrics, medicine.medical_specialty, Adolescent, Hospital setting, Trypanosoma brucei gambiense, 030231 tropical medicine, lcsh:Medicine, Diagnostic accuracy, Rapid diagnostic test, General Biochemistry, Genetics and Molecular Biology, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Agglutination Tests, parasitic diseases, medicine, Humans, African trypanosomiasis, 030212 general & internal medicine, Stage (cooking), Child, Recent onset, Aged, Demography, lcsh:R5-920, Diagnostic Tests, Routine, business.industry, Human African trypanosomiasis, lcsh:R, Outcome measures, General Medicine, Middle Aged, Reference Standards, medicine.disease, Confidence interval, 3. Good health, Trypanosomiasis, African, Democratic Republic of the Congo, Sensitivity& specificity, Female, business, lcsh:Medicine (General), Research Paper |
| الوصف: | Objectives To estimate the diagnostic accuracy of HAT Sero K-SeT for the field diagnosis of second-stage human African trypanosomiasis (HAT). Design A phase III diagnostic accuracy design. Consecutive patients with symptoms clinically suggestive of HAT were prospectively enrolled. We compared results of the index test HAT Sero K-SeT with those of a composite reference standard: demonstration of trypanosomes in cerebrospinal fluid (CSF), or trypanosomes detected in any other body fluid AND white blood cell count in CSF > 5/μl. Setting Rural hospital in the Democratic Republic of the Congo. Participants All patients above five years old presenting at Mosango hospital with a neurological problem of recent onset at the exclusion of trauma. Interventions n.a. Main Outcome Measures Sensitivity and specificity of HAT Sero K-SeT test. Results The sensitivity of the HAT Sero K-SeT was 8/8 or 100.0% (95% confidence interval: 67.6 to 100.0%) and the specificity was 258/266 or 97.0% (94.2% to 98.5%). Conclusion The high sensitivity of the HAT Sero K-SeT is in line with previously published estimates, though the sample of HAT cases in this study was small. The specificity estimate was very high and precise. This test, when negative, allows the clinician to rule out HAT in a clinical suspect in a hospital setting in this endemic region. Highlights • The HAT Sero K-SeT was evaluated in a rural hospital on patients with a neurological syndrome. • This new rapid diagnostic test for sleeping sickness was highly sensitive and specific. • A negative HAT Sero K-SeT test allows to rule out sleeping sickness in this setting. Rapid Diagnostic Tests (RDT) are promising tools for clinical management of sleeping sickness or Human African Trypanosomiasis (HAT), as most patients live in remote rural areas in Central or West Africa. We evaluated the HAT Sero-K-SeT, a novel RDT in a series of consecutively enrolled patients with clinical symptoms suggestive of second-stage sleeping sickness. This design is known as phase III in diagnostic accuracy studies, as the patient set is representative of future use of the RDT. The test showed high sensitivity and specificity. We conclude that in such patients, an RDT for HAT should be done. If negative, HAT can be ruled out. If positive, the likelihood of HAT is very high. |
| اللغة: | English |
| تدمد: | 2352-3964 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b08c87ce844106e82ae428da3be46a87 http://www.sciencedirect.com/science/article/pii/S2352396417304383 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....b08c87ce844106e82ae428da3be46a87 |
| قاعدة البيانات: | OpenAIRE |
Full Text via ClinicalKey | تدمد: | 23523964 |
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