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
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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