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U.S. Department of Health and Human Services


Guide to the Application of Genotyping to Tuberculosis Prevention and Control

Developing a Tuberculosis Genotyping Program

Developing a Written Plan

TB Programs should develop a written plan to describe activities, responsibilities, and procedures for their TB genotyping programs. The New York City and the Maryland TB programs graciously agreed to share copies of their genotyping plans with other TB controllers. These plans are posted on the WebBoard at

To help TB programs develop a plan, Table 5.1 lists important initial steps that should be considered. Which steps are required and which are recommended depend on the decision the TB program makes about the initial scope of their genotyping program. How to make the decision about the initial scope of the genotyping program and the steps in Table 5.1 are discussed in the next section of this chapter.

Table 5.1.  Steps in establishing a state genotyping program plan.

  Universal: statewide Universal: subregion Selective
1. Identify labs that might submit isolates
Required Required Recommended
2. Notify submitting labs of genotyping program and provide them with a copy of the TB Genotyping Isolate Submission form
Required Required Recommended
3. Negotiate payment for shipping isolates to genotyping laboratories
Required Required Recommended
4. Establish submission procedures: batch shipments, frequency of shipments, avoiding duplicate submissions
Required Required Required
5. Establish an isolate tracking system
Required Required Required
6. Establish criteria for selecting isolates to be submitted
does not apply does not apply Recommended
7. Establish procedures to identify isolates selected for submission
does not apply does not apply Required
8. Assign responsibility to the person who will receive Genotyping Laboratory Report
Required Required Required
9. Establish a genotyping data management system
Required Required Required
10. Establish procedures for evaluating genotyping results and other existing data to make decisions about need for additional investigations, such as cluster or outbreak investigations (see Figure 5.1)
Required Required Required
11. Establish criteria for requesting RFLP
Required Required Required
12. Consider advocating for a new state health regulation to submit one isolate/patient to state public health laboratory
Recommended Recommended Recommended
13. Consider networking with adjacent TB programs to encourage interjurisdictional exchange of genotyping information
Recommended Recommended Recommended
14. Obtain CDC approval for plan
Required Required Required


Released October 2008
Centers for Disease Control and Prevention
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination -

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