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Free Content Surveillance of anti-tuberculosis drug resistance: results of the 1998/1999 proficiency testing in Italy

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OBJECTIVE: To determine the accuracy of drug-susceptibility testing (DST) for isoniazid, rifampicin, ethambutol and streptomycin in a provisional network of 22 regional laboratories in Italy.

METHODS: Methods, definitions and reference Mycobacterium tuberculosis strains were derived from the WHO/IUATLD Global Project on Anti-tuberculosis Drug Resistance Surveillance. The laboratories were selected based on technical skills required by the project, the number of DST performed annually and geographic localisation. The results (sensitive/resistant strain) were compared with the gold standard (global project results). Sensitivity (ability to detect true resistance), specificity (ability to detect true susceptibility), positive predictive values for resistance and susceptibility, efficiency and reproducibility were calculated in two rounds.

RESULTS: Eighteen of 22 laboratories completed the first round of proficiency testing for the four drugs. Sensitivity was 76.6%, specificity 97.2%, predictive value of a resistant test 89.8% and of a susceptible test 86.8%, efficiency 87.8% and reproducibility 92.8%. A second round was performed by all those laboratories that did not achieve ≥90% agreement with the results of the Global Project. Overall, after the second round, all the parameters except specificity improved, exceeding 90%.

CONCLUSIONS: A network of 15 regional laboratories that fulfil the quality criteria for determining the susceptibility of M. tuberculosis to the four primary anti-tuberculosis drugs was established in Italy.
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Keywords: drug susceptibility testing; proficiency testing; tuberculosis

Document Type: Regular Paper

Affiliations: 1: Fondazione S. Maugeri, Care and Research Institute, Tradate, Italy 2: Fondazione S. Maugeri, Care and Research Institute, Tradate, Italy; and the Department of Clinical and Biological Sciences, University of Insubria, Varese, Italy 3: Supranational Reference Laboratory, Department of Bacteriology and Medical Mycology, Istituto Superiore di Sanità, Rome, Italy 4: National Reference Laboratory, Villa Marelli Institute, Milan, Italy 5: Institute of Clinic of Infectious Diseases, University ‘Cattolica del Sacro Cuore’, Rome, Italy 6: Institute of Pulmonary Diseases, University of Modena, Modena, Italy 7: Department of Clinical and Biological Sciences, University of Insubria, Varese, Italy; and the Supranational Reference Laboratory, Department of Bacteriology and Medical Mycology, Istituto Superiore di Sanità, Rome, Italy

Publication date: October 1, 2000

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  • 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.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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