Mycobacterium tuberculosis Drug Resistance by Sequencing
Ordering Recommendation

Order for rapid identification of mutations associated with drug resistance for M. tuberculosis treatment. For phenotypic drug susceptibility testing, refer to Antimicrobial Susceptibility, AFB/Mycobacterium tuberculosis Primary Panel (0060347).

Polymerase Chain Reaction/Sequencing
5-7 days
New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
Pure culture of M. tuberculosis complex on solid or liquid media. 
Specimen Preparation
Transport sealed container with pure culture on solid or in liquid media. Place each specimen in an individually sealed bag. 
Storage/Transport Temperature
Room temperature. Submit specimen according to Infectious Substance, Category A, shipping guidelines. 
Unacceptable Conditions
Mixed cultures, isolates other than M. tuberculosis complex, non-viable organism. Agar Plates. 
Organism identification required. 
Ambient: 2 weeks; Refrigerated: 2 weeks; Frozen: Unacceptable 
Reference Interval
Interpretive Data
This assay detects known resistance mutations in subregions of the M. tuberculosis rpoB, katG, and embB genes and the inhA promoter by sequencing. This assay does not determine drug resistance originating from other genes or mechanisms. Mutations in sub-populations below 20 percent of total may not be detected. Results should not be used as a substitute for routine (phenotypic) susceptibility testing.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Hotline History
Component Test Code*Component Chart NameLOINC
2011714TB Rifampin Resistance by Sequencing48176-2
2011715TB Isoniazid Resistance by Sequencing48175-4
2011716TB Ethambutol Resistance by Sequencing46247-3
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
  • AFB primary panel
  • Ethambutol susceptibility
  • isoniazid susceptibility
  • pyrazinamide susceptibility
  • rifampin susceptibility