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Use of the MDDR service by submitters

What are the MDDR submission criteria for MTBC clinical isolates?

Isolates may be submitted for molecular detection of drug resistance if one of the following criteria is met:

  1. High-risk of RIF resistance or MDR-TB (including previously treated TB case, drug resistant TB contact, foreign-born from area with high rates of MDR TB)
  2. Known RIF resistant isolates
  3. High profile patients (e.g. daycare workers, nurses)
  4. Adverse reactions (e.g. patient allergic to RIF)
  5. Mixed or non-viable cultures
  6. other situations considered on case by case basis

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What sample types will be accepted?

Isolates of M. tuberculosis complex will be accepted for the service.  MDDR testing has not been validated for clinical specimens (e.g., raw or processed sputum).  Isolates can be submitted on either solid media (e.g. LJ or Middlebrook) or as positive MGIT cultures.  Validation of MDDR testing from other types of liquid media is underway and may be accepted in the future.  Bactec460 bottles will not be accepted.  The laboratories should submit only one sample per patient; however, duplicate samples can be considered on a case by case basis. 

In order to effectively utilize rapid methods, please submit eligible culture isolates as soon as they are identified as MtbC.  In most cases, a positive MGIT culture will be available before a solid culture.  When shipping liquid culture, please send 1 ml of culture in a screw-cap cryovial that has been sealed with parafilm.

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How do I submit an isolate for the MDDR service?

Submitters should complete the MDDR request form and submit via email to TBLab@cdc.gov.  Once approved, the LB will send an email with further submission instructions and a DASH form.  Please attach the MDDR request form to the DASH form when shipping isolates.  Isolates should be shipped via overnight service to CDC Monday through Thursday only.  Do not ship isolates on Friday.

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How will MDDR results be reported?

An interim report will be issued to the submitter when MDDR results are available.  This report will contain appropriate patient identification and submitter information.  Results will be summarized in a table to indicate the locus sequenced, sequencing results (WT or amino acid change designation), and interpretation of sequencing results in terms of what is known about the association of the mutation with drug resistance.

A final report will be issued when conventional DST results are available.  This report will contain both the molecular and conventional DST results and final drug susceptibility profile.  Comments regarding discordance, if appropriate, will be included.

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