| The Centers for Disease Control and Prevention (CDC) is
conducting a voluntary performance evaluation program to assess the
laboratory's susceptibility testing process for drug-resistant strains of
Mycobacterium tuberculosis and nontuberculous mycobacteria. Benefits of
laboratory participation include the opportunity to conduct a free, anonymous
self-assessment that will improve testing processes and will prepare
laboratories to satisfy mandatory testing requirements.
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| Clinical mycobacteriology laboratories have a key role in combating this public
health problem. By participating in this program developed by CDC's Public
Health Practice Program Office, Division of Laboratory Systems, laboratories
can use this self-assessment tool to help maximize skills in mycobacteriology.
Participation in the program is voluntary and anonymity of individual
laboratory contributions to the program will be maintained. |
| This is not a proficiency testing program. Therefore, the testing
components of the program are not intended for use by a laboratory to satisfy
any regulatory requirement for participation in a proficiency testing program.
Results will be reported solely on aggregate data of all participating
laboratories. Other benefits of laboratory participation are: |
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Analysis of characterized and referenced cultures with attributes closely
resembling those of cultures encountered in routine clinical testing;
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Summary of aggregate methods and results reported by all participant
laboratories for drug susceptibility testing;
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Provision of a mechanism for performing self-assessment for improvement of
laboratory performance;
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Detection of problems with test systems and reagents;
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Receipt of reference strains of M. tuberculosis and nontuberculous mycobacteria
to be used for future quality control;
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Access to sources for technical consultations; and
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Contribution to a system to improve or maintain the high quality of drug
susceptibility testing.
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| Program participants will conduct periodic testing of performance evaluation
panels (Lowenstein-Jensen slants) in the same manner that they evaluate patient
isolates. Panels consist of M. tuberculosis and nontuberculous mycobacteria
strains with M. tuberculosis strains exhibiting patterns of resistance to the
primary anti-tuberculosis drugs (e.g., isoniazid, rifampin, ethambutol and
pyrazinamide). Laboratories will submit testing results and provide CDC with
information about the methods used. Shipment dates for the performance
evaluation panels will be announced. One month after CDC receives all
responses, each participant laboratory will be provided with a preliminary
report reflecting the susceptibility testing results for each culture. A
detailed aggregate report of results and methods reported by all participants
(without identification of individual laboratories) for each panel culture will
be mailed before shipment of the next panel of M. tuberculosis and
nontuberculous mycobacteria isolates. |
| Only laboratories following Biosafety Level 3 practices are eligible for
participation. Biosafety Level 2 facilities with Level 3 containment equipment
are acceptable. CDC requests that participant laboratories follow guidelines
described in the Biosafety
in Microbiological and Biomedical Laboratories (BMBL), 4th Edition,
1999 Publication No.017-040-00547-4. For more information, call the U.S.
Government Printing Office (1-866-512-1800) |
| International participation is limited to laboratories which have public health
responsibilities for tuberculosis drug susceptibility testing and approval by
their National Tuberculosis Program. |
| CDC has contracted with DynCorp, an independent scientific service
organization, to assist in collecting enrollment information. If you have
questions about enrollment and would like to participate, please contact: |
Teena Abel
Project Coordinator
Computer Sciences Corporation (CSC), formerly DynCorp
6101 Stevenson Avenue
Alexandria, VA 22304
703.461.2126
E-mail: tabel@csc.com
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| If you have questions concerning the performance evaluation program, contact: |
Pawan Angra, MS, DCPSA, PhD
Project Officer
Laboratory Systems Development Branch
Division of Laboratory Systems
NCPDCID/CCID/CDC
1600 Clifton Road, MS G-25
Atlanta, GA 30333
Phone: 404.498.2295
Fax: 404.498.2210
E-mail: pangra@cdc.gov
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| Internet information: http://www.cdc.gov/mpep/mtbds.aspx
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