Assessment of the novel T-cell activation marker–tuberculosis assay for diagnosis of active tuberculosis in children: a prospective proof-of-concept study
| Autor: | Felicien Moukambi, Fred Lwilla, Elmar Saathoff, Khadija Said, Asli Bauer, Frederick Haraka, Andrea Rachow, Mkunde Chachage, Damien Portevin, Christof Geldmacher, Ben J. Marais, Levan Jugheli, Nyanda E. Ntinginya, Claudia Daubenberger, Klaus Reither, Michael Hoelscher, Petra Clowes, Elirehema Mfinanga, Maximilian Mpina |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Male
medicine.medical_specialty Time Factors Tuberculosis Adolescent Disease Immunologic Tests Lymphocyte Activation Sensitivity and Specificity Tanzania Tuberculosis diagnosis Internal medicine Humans Medicine Blood test Prospective Studies Child medicine.diagnostic_test Latent tuberculosis business.industry Sputum Infant Reproducibility of Results Mycobacterium tuberculosis medicine.disease 3. Good health Clinical trial Infectious Diseases Specimen collection Child Preschool Immunology Leukocytes Mononuclear Female medicine.symptom business Biomarkers |
| Zdroj: | The Lancet Infectious Diseases. 14:931-938 |
| ISSN: | 1473-3099 |
| Popis: | Summary 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|