| The Centers for Disease Control and Prevention (CDC) is conducting a voluntary
performance evaluation program to assess the laboratory's testing process for
nucleic acid amplification (NAA) tests for Mycobacterium tuberculosis.
Benefits of laboratory participation include the opportunity to conduct a free,
anonymous self assessment that promote sharing of information for improving the
testing processes.
Culture identification of M. tuberculosis, even with the recommended
rapid methods, requires a minimum of 14-21 days. The FDA has approved two
commercial NAA tests that offer the opportunity to provide early confirmation
of M. tuberculosis infection. Although these tests provide rapid
results, questions remain about appropriate guidance for infection control,
patient management, and tuberculosis control.
Clinical mycobacteriology laboratories have a key role in slowing the spread of M.
tuberculosis. 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 with NAA
tests. CDC has contracted with the Wisconsin State Laboratory of Hygiene (WSLH)
a university-based public health service organization, to collect enrollment
information, develop and ship test samples, and forward aggregate results to
CDC for analyses. 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
the regulatory requirement for participation in a proficiency testing program.
Results will be reported solely on aggregate data. Individual performance
reports will not be provided.
Other benefits of laboratory participation are:
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Analysis of reference samples with attributes resembling those of specimens
encountered in routine clinical testing;
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Evaluation of aggregate methods and results reported by other participant
laboratories for NAA tests for M. tuberculosis;
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Provision of a mechanism for performing self assessment for improvement;
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Detection of problems with test systems and reagents;
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Contribution to a system to improve or maintain the high quality of the testing
process.
Program participants will conduct periodic testing of performance evaluation
samples in the same manner that they evaluate patient isolates. Panels consist
of M. tuberculosis and other mycobacteria in samples that mimic
pre-treated (decontaminated/concentrated) patient specimens. Laboratories will
submit testing results and provide CDC with information about the methods used.
Shipment dates for the performance evaluation panels will be announced.
Each participant laboratory will be provided with a preliminary report
reflecting the reference testing results for each test sample one month after
CDC receives all responses. A detailed aggregate report of results and methods
reported by all participants (without identification of individual
laboratories) for each sample will be mailed before shipment of the next panel
of test samples.
Only laboratories following at a minimum, Biosafety Level 2 practices are
eligible for participation. CDC requests that participant laboratories follow
guide-lines described in the CDC Biosafety Manual, 1999 Edition,
Publication No. CDC-93-8395.
If you have questions about enrollment and would like to participate, please
contact:
Judy Nichols, MT (ASCP)
M. tuberculosis NAA Performance Evaluation Coordinator
Wisconsin State Laboratory of Hygiene
465 Henry Mall, Rm. 402
Madison, WI 53706-1578
800-462-5261 ext. 56
For questions concerning the program, please contact:
Laurina O. Williams, Ph.D.
Centers for Disease Control and Prevention
Division of Laboratory Systems
1600 Clifton Road, NE
Mail Stop G23
Atlanta, GA 30333
404-718-1047
Fax: 404-718-1099
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