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Performance Evaluation Program for Mycobacterium tuberculosis Drug-Susceptibility Testing Process

As part of the continuing initiative for assessing the quality and effectiveness of laboratory testing systems to support public health objectives and disease surveillance, prevention, and treatment programs, CDC is conducting a performance evaluation program to assess the drug-susceptibility testing process of laboratories for multidrug-resistant strains of Mycobacterium tuberculosis. Participation in the program, which is not designed to satisfy regulatory requirements, is voluntary and free of charge. Anonymity of individual laboratory contributions to the program is maintained.

Program participants will perform periodic drug-susceptibility testing on performance evaluation panels (Lowenstein-Jensen slants) in the same manner by which they evaluate patient isolates. Panels consist of strains of M. tuberculosis exhibiting patterns of resistance to the primary antituberculosis drugs (e.g., isoniazid, rifampin, pyrazinamide, ethambutol, and streptomycin). Only laboratories following Biosafety Level 3 practices are eligible to participate (Biosafety Level 2 facilities with Level 3 containment equipment are acceptable). Participant laboratories should follow guidelines described in the Biosafety in Microbiological and Biomedical Laboratories (1), 1993 edition.

Participants in the program should benefit by 1) analyzing referenced cultures that closely resemble the cultures they may encounter in routine clinical testing; 2) comparing results and methods reported by other participant laboratories for commonly analyzed cultures; 3) comparing quality-control results and procedures; 4) having a mechanism for performing self-assessment of individual performance; and 5) detecting problems with instrumentation and reagents.

Additional information is available from the Division of Laboratory Systems, Public Health Practice Program Office, CDC, 4770 Buford Highway, NE, Building 102, Mailstop G-23, Atlanta, GA 30341; telephone (404) 488-7685; fax (404) 488-7693.

Reference

  1. CDC/National Institutes of Health. Biosafety in microbiological and biomedical laboratories. 3rd ed. Atlanta: US Department of Health and Human Services, Public Health Service, CDC/ National Institutes of Health, 1993; DHHS publication no. (CDC)93-8395.



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