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Assessment of the novel T-cell activation marker-tuberculosis assay for diagnosis of active tuberculosis in children : a prospective proof-of-concept study

Portevin, Damien and Moukambi, Felicien and Clowes, Petra and Bauer, Asli and Chachage, Mkunde and Ntinginya, Nyanda E. and Mfinanga, Elirehema and Said, Khadija and Haraka, Frederick and Rachow, Andrea and Saathoff, Elmar and Mpina, Maximilian and Jugheli, Levan and Lwilla, Fred and Marais, Ben J. and Hoelscher, Michael and Daubenberger, Claudia and Reither, Klaus and Geldmacher, Christof. (2014) Assessment of the novel T-cell activation marker-tuberculosis assay for diagnosis of active tuberculosis in children : a prospective proof-of-concept study. The Lancet infectious diseases, Vol. 14, H. 10. pp. 931-938.

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Official URL: http://edoc.unibas.ch/dok/A6308524

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Abstract

The diagnosis of paediatric tuberculosis is complicated by non-specific symptoms, difficult specimen collection, and the paucibacillary nature of the disease. We assessed the accuracy of a novel immunodiagnostic T-cell activation marker-tuberculosis (TAM-TB) assay in a proof-of-concept study to identify children with active tuberculosis.; Children with symptoms that suggested tuberculosis were prospectively recruited at the NIMR-Mbeya Medical Research Center in Mbeya, and the Ifakara Health Institute in Bagamoyo, Tanzania, between May 10, 2011, and Sept 4, 2012. Sputum and peripheral blood mononuclear cells were obtained for Mycobacterium tuberculosis culture and performance assessment of the TAM-TB assay. The children were assigned to standardised clinical case classifications based on microbiological and clinical findings.; Among 290 children screened, we selected a subgroup of 130 to ensure testing of at least 20 with culture-confirmed tuberculosis. 17 of 130 children were excluded because of inconclusive TAM-TB assay results. The TAM-TB assay enabled detection of 15 of 18 culture-confirmed cases (sensitivity 83·3%, 95% CI 58·6-96·4). Specificity was 96·8% (95% CI 89·0-99·6) in the cases that were classified as not tuberculosis (n=63), with little effect from latent tuberculosis infection. The TAM-TB assay identified five additional patients with highly probable or probable tuberculosis, in whom M tuberculosis was not isolated. The median time to diagnosis was 19·5 days (IQR 14-45) for culture.; The sputum-independent TAM-TB assay is a rapid and accurate blood test that has the potential to improve the diagnosis of active tuberculosis in children.; European and Developing Countries Clinical Trials Partnership, German Federal Ministry of Education and Research, and Swiss National Science Foundation.
Faculties and Departments:09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH)
09 Associated Institutions > Swiss Tropical and Public Health Institute (Swiss TPH) > Department of Medical Parasitology and Infection Biology > Clinical Immunology (Daubenberger)
UniBasel Contributors:Portevin, Damien and Daubenberger, Claudia and Reither, Klaus
Item Type:Article, refereed
Article Subtype:Research Article
Bibsysno:Link to catalogue
Publisher:Elsevier
ISSN:1473-3099
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:07 Nov 2014 08:28
Deposited On:07 Nov 2014 08:28

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