Evaluation of a rapid culture method for tuberculosis diagnosis: a Latin American multi-center study
Abstract:SETTINGS: Tuberculosis (TB) diagnostic laboratories in Latin America.
OBJECTIVES: Evaluation of thin-layer agar (TLA) compared to Löwenstein-Jensen (LJ) culture for the diagnosis of TB.
DESIGN: Phase II prospective study in six laboratories. Samples included sputum and extra-pulmonary specimens from patients with a clinical diagnosis of TB. Respiratory samples were decontaminated using NaOH/NALC; all samples were centrifuged, stained with Ziehl-Neelsen for acid-fast bacilli (AFB), cultured on LJ and TLA and identified according to recommended procedures. Sensitivity and likelihood ratios (LR), growth detection time and contamination rate were calculated for both media.
RESULTS: A total of 1118 clinical specimens were studied. Cultures detected Mycobacterium tuberculosis in all AFB-positive samples, whereas for AFB-negative specimens LJ detected 3.2% and TLA 4.4%. Sensitivity was 92.6% (95%CI 87.9–95.9) and 84.7% (95%CI 78.8–89.0) for TLA and LJ, respectively. Positive and negative LRs were similar. Contamination was 5.1% for TLA and 3.0% for LJ. Median time to detection of a positive culture was 11.5 days (95%CI 9.3–15.0) for TLA and 30.5 days (95%CI 26.9–39.0) for LJ (P < 0.0001).
CONCLUSION: Difference in the characteristics of the participating laboratories, the disease prevalence and the number and type of specimens processed did not affect the overall performance of TLA as compared to LJ, supporting the robustness of the method and its feasibility in different laboratory settings.
Document Type: Regular Paper
Affiliations: 1: Laboratorio Regional de Referencia de Micobacterias, Hospital Cetrángolo, Buenos Aires, Buenos Aires, Argentina 2: Departamento de Micobacterias, Centro Nacional de Diagnóstico y Referencia, Ministerio de Salud, Managua, Nicaragua 3: Instituto Nacional de Laboratorios de Salud (INLASA), La Paz, Bolivia 4: Escuela Nacional de Ciencias Biológicas, Instituto Politecnico Nacional, Mexico, DF, Mexico 5: Laboratorio de Microbiología y Tuberculosis, Hospital Vozandes, Quito, Ecuador 6: Sección de Micobacterias, Instituto de Salud Pública de Chile, Santiago de Chile, Chile 7: Institute of Tropical Medicine, Antwerp, Belgium
Publication date: June 1, 2006
The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.
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