Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2014 Oct;14(10):931-8.
doi: 10.1016/S1473-3099(14)70884-9. Epub 2014 Aug 31.

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

Damien Portevin  1 , Felicien Moukambi  2 , Petra Clowes  2 , Asli Bauer  2 , Mkunde Chachage  3 , Nyanda E Ntinginya  3 , Elirehema Mfinanga  4 , Khadija Said  4 , Frederick Haraka  4 , Andrea Rachow  5 , Elmar Saathoff  5 , Maximilian Mpina  4 , Levan Jugheli  6 , Fred Lwilla  4 , Ben J Marais  7 , Michael Hoelscher  5 , Claudia Daubenberger  1 , Klaus Reither  8 , Christof Geldmacher  9
Affiliations

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

Damien Portevin et al. Lancet Infect Dis. 2014 Oct.

Abstract

Background: 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.

Methods: 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.

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.

Interpretation: 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.

Funding: European and Developing Countries Clinical Trials Partnership, German Federal Ministry of Education and Research, and Swiss National Science Foundation.

PubMed Disclaimer

Comment in

  • Novel biomarkers for paediatric tuberculosis.
    Van Rie A, Moultrie H. Van Rie A, et al. Lancet Infect Dis. 2014 Oct;14(10):900-1. doi: 10.1016/S1473-3099(14)70898-9. Epub 2014 Aug 31. Lancet Infect Dis. 2014. PMID: 25185460 No abstract available.

Publication types

MeSH terms

LinkOut - more resources