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Mycobacterium TB Complex (International Only) Identification and Drug Susceptibility Testing
 CDC-10352

Synonym(s)
Culture, DST, AST, MTB, MDR TB
CDC Pre-Approval Needed
Patricia Hall Eidson
(404) 718-1440
igg5@cdc.gov
Kyle DeGruy
(404) 639-0875
gsz4@cdc.gov
Supplemental Information Required
Contact the CDC POCs 1) for approval to send isolates to CDC for testing, 2) to obtain appropriate forms for submission and 3) to obtain information/ materials to assist with the submission process.
Supplemental Form
Performed on Specimens from
Human
Acceptable Sample/ Specimen Type for Testing
Pure isolates of suspected Mycobacterium tuberculosis complex (MTBC)
Minimum Volume Required
0.3 mL
Collection, Storage, and Preservation of Specimen Prior to Shipping
Store MTBC isolates with or without glycerol in sterile 2.0 mL screw cap cryovials with O-rings. Isolates should be stored at -60 °C to -70 °C until shipped to preserve the viability of MTBC.
Transport Medium
Middlebrook 7H9 or Mycobacterial Growth Indicator Tube (MGIT) liquid media
Specimen Labeling
Research or surveillance isolates may be labeled according to protocol. Labels should not include personally identifiable information. The results reported should NOT be used for diagnosis, treatment, assessment of health or management of the individual patient.
Shipping Instructions which Include Specimen Handling Requirements
Store specimens at -60 °C to -70 °C until packed for shipping. Ship specimens in triple packaging and on dry ice.
 
CDC does not accept routine shipments on weekends or holidays. Please make sure packages arrive Monday - Friday.
 
Ship to:
<Insert CDC Point of Contact>
Centers for Disease Control and Prevention
RDSB/STATT Unit 99
1600 Clifton Road, NE
Atlanta, GA 30329
<Insert CDC Point of Contact's Telephone Number>
 
All samples must be shipped in accordance with all applicable local, state and federal regulations. Upon shipment, submitter should send an e-mail to the CDC POC providing shipping company, shipped date and package tracking number.
Methodology
MGIT 960 SIRE and PZA drug susceptibility testing, GenoType MTBDRplus, GenoType MTBDRsl, GenoType CM, Xpert MTB/RIF, Xpert MTB/RIF Ultra
Turnaround Time
22 Weeks
Interferences & Limitations
Testing will not be performed on nonviable, contaminated or mixed isolates.
Additional Information
22 weeks trunaround time for batches with less than 100 isolates. Contact CDC POC for batches greater than 100 isolates. Isolates may be rejected if improperly labeled, missing or discrepant documentation, insufficient volume for testing or leaking containers.
 
CDC Points of Contact
Patricia Hall Eidson
(404) 718-1440
igg5@cdc.gov
Kyle DeGruy
(404) 639-0875
gsz4@cdc.gov
Zilma Rey
(404) 639-2345
yzr0@cdc.gov
Mariela Scarbrough
(404) 639-1389
hqz4@cdc.gov
Version
1.5