دورية أكاديمية
أعرض في EDS

Sensitivity and Specificity of a Prototype Rapid Diagnostic Test for the Detection of Trypanosoma brucei gambiense Infection: A Multi-centric Prospective Study.

التفاصيل البيبلوغرافية
العنوان: Sensitivity and Specificity of a Prototype Rapid Diagnostic Test for the Detection of Trypanosoma brucei gambiense Infection: A Multi-centric Prospective Study.
المؤلفون: Bisser S; INSERM UMR1094, Institute of Neuroepidemiology and Tropical Neurology, Limoges, France., Lumbala C; Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), Kinshasa, Democratic Republic of the Congo., Nguertoum E; Institut Centrafricain de la Recherche Agronomique (ICRA), Bangui, Central African Republic., Kande V; Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), Kinshasa, Democratic Republic of the Congo., Flevaud L; Médecins Sans Frontières (MSF) Operational Centre Barcelona-Athens (OCBA), Barcelona, Spain., Vatunga G; Instituto de Combate e Controlo das Tripanossomiases, Luanda, Angola., Boelaert M; Institute of Tropical Medicine Antwerp, Antwerpen, Belgium., Büscher P; Institute of Tropical Medicine Antwerp, Antwerpen, Belgium., Josenando T; Instituto de Combate e Controlo das Tripanossomiases, Luanda, Angola., Bessell PR; Epi Interventions Ltd., Edinburgh, United Kingdom., Biéler S; Foundation for Innovative New Diagnostics, Campus Biotech, Geneva, Switzerland., Ndung'u JM; Foundation for Innovative New Diagnostics, Campus Biotech, Geneva, Switzerland.
المصدر: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2016 Apr 08; Vol. 10 (4), pp. e0004608. Date of Electronic Publication: 2016 Apr 08 (Print Publication: 2016).
نوع المنشور: Comparative Study; Evaluation Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101291488 Publication Model: eCollection Cited Medium: Internet ISSN: 1935-2735 (Electronic) Linking ISSN: 19352727 NLM ISO Abbreviation: PLoS Negl Trop Dis Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Chromatography, Affinity/*methods , Diagnostic Tests, Routine/*methods , Trypanosoma brucei gambiense/*isolation & purification , Trypanosomiasis, African/*diagnosis, Angola ; Central African Republic ; Democratic Republic of the Congo ; Humans ; Prospective Studies ; Sensitivity and Specificity ; Time Factors
مستخلص: Background: A major challenge in the control of human African trypanosomiasis (HAT) is lack of reliable diagnostic tests that are rapid and easy to use in remote areas where the disease occurs. In Trypanosoma brucei gambiense HAT, the Card Agglutination Test for Trypanosomiasis (CATT) has been the reference screening test since 1978, usually on whole blood, but also in a 1/8 dilution (CATT 1/8) to enhance specificity. However, the CATT is not available in a single format, requires a cold chain for storage, and uses equipment that requires electricity. A solution to these challenges has been provided by rapid diagnostic tests (RDT), which have recently become available. A prototype immunochromatographic test, the SD BIOLINE HAT, based on two native trypanosomal antigens (VSG LiTat 1.3 and VSG LiTat 1.5) has been developed. We carried out a non-inferiority study comparing this prototype to the CATT 1/8 in field settings.
Methodology/principal Findings: The prototype SD BIOLINE HAT, the CATT Whole Blood and CATT 1/8 were systematically applied on fresh blood samples obtained from 14,818 subjects, who were prospectively enrolled through active and passive screening in clinical studies in three endemic countries of central Africa: Angola, the Democratic Republic of the Congo and the Central African Republic. One hundred and forty nine HAT cases were confirmed by parasitology. The sensitivity and specificity of the prototype SD BIOLINE HAT was 89.26% (95% confidence interval (CI) = 83.27-93.28) and 94.58% (95% CI = 94.20-94.94) respectively. The sensitivity and specificity of the CATT on whole blood were 93.96% (95% CI = 88.92-96.79) and 95.91% (95% CI = 95.58-96.22), and of the CATT 1/8 were 89.26% (95% CI = 83.27-93.28) and 98.88% (95% CI = 98.70-99.04) respectively.
Conclusion/significance: After further optimization, the prototype SD BIOLINE HAT could become an alternative to current screening methods in primary healthcare settings in remote, resource-limited regions where HAT typically occurs.
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تواريخ الأحداث: Date Created: 20160409 Date Completed: 20160808 Latest Revision: 20191210
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC4825971
DOI: 10.1371/journal.pntd.0004608
PMID: 27058033
قاعدة البيانات: MEDLINE
الوصف
تدمد:1935-2735
DOI:10.1371/journal.pntd.0004608