Mycobacterium tuberculosis Drug Resistance by Sequencing
2011713
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).
Mnemonic
TB RESIST
Methodology
Polymerase Chain Reaction/Sequencing
Performed
Sun-Sat
Reported
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
Specimen Required
- Patient Preparation
- Collect
- 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. If culture is suspected of being a microorganism listed as infectious substance affecting humans on IATA list, submit specimen
according to Biological Substance, Category A, shipping guidelines. - Unacceptable Conditions
- Mixed cultures, isolates other than M. tuberculosis complex, non-viable organism. Agar Plates.
- Remarks
- Organism identification required.
- Stability
- 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.
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2011714 | TB Rifampin Resistance by Sequencing | 48176-2 |
| 2011715 | TB Isoniazid Resistance by Sequencing | 48175-4 |
| 2011716 | TB Ethambutol Resistance by Sequencing | 46247-3 |
Aliases
- AFB primary panel
- Ethambutol susceptibility
- isoniazid susceptibility
- pyrazinamide susceptibility
- rifampin susceptibility