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

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.

Barriers to conducting effective obstetric audit in Ifakara: a qualitative assessment in an under-resourced setting in Tanzania.

OBJECTIVE: To explore barriers to and solutions for effective implementation of obstetric audit at Saint Francis Designated District Hospital in Ifakara, Tanzania, where audit results have been disappointing 2 years after its introduction. METHODS: Qualitative study involving participative observation of audit sessions, followed by 23 in-depth interviews with health workers and managers. Knowledge and perceptions of audit were assessed and suggestions for improvement of the audit process explored. RESULTS: During the observational period, audit sessions were held irregularly and only when the head of department of obstetrics and gynaecology was available. Cases with evident substandard care factors were audited. In-depth interviews revealed inadequate knowledge of the purpose of audit, despite the fact that participants regarded obstetric audit as a potentially useful tool. Insufficient staff commitment, managerial support and human and material resources were mentioned as reasons for weak involvement of health workers and poor implementation of recommendations resulting from audit. Suggestions for improvement included enhancing feedback to all staff and managers to attend sessions and assist with the effectuation of audit recommendations. CONCLUSION: Obstetric staff in Ifakara see audit as an important tool for quality improvement. They recognise, however, that in their own situation, insufficient staff commitment and poor managerial support are barriers to successful implementation. They suggested training in concept and principles of audit as well as strengthening feedback of audit outcomes, to achieve structural health care improvements through audit.