Test Id : DMTBR
Mycobacterium tuberculosis Complex, Molecular Detection of Drug Resistance Markers, Next-Generation Sequencing
Useful For
Suggests clinical disorders or settings where the test may be helpful
Molecular detection of drug resistance variants in culture isolates of the Mycobacterium tuberculosis complex
May provide a more rapid detection of drug resistance than phenotypic, broth-based testing for selected gene targets
Aiding in the resolution of discrepant results obtained using phenotypic methods
Testing for M tuberculosis complex isolates that are not sufficiently viable to allow for culture-based testing
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Next-Generation sequencing (NGS) of Mycobacterium tuberculosis complex isolates is performed followed by evaluation of selected genes of interest for the presence of well-characterized, drug resistance-conferring variants.
Method Name
A short description of the method used to perform the test
Next-Generation Sequencing (NGS)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Next Generation Sequencing Test
Mycobacterium tuberculosis Drug Susceptibility Test
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Next-Generation sequencing (NGS) of Mycobacterium tuberculosis complex isolates is performed followed by evaluation of selected genes of interest for the presence of well-characterized, drug resistance-conferring variants.
Specimen Type
Describes the specimen type validated for testing
Varies
Ordering Guidance
This test is used to identify the drug resistance variants in an M tuberculosis complex culture isolate.
Shipping Instructions
1. For shipping information see Infectious Specimen Shipping Guidelines
2. Place specimen in a large infectious container (T146) and label as an etiologic agent/infectious substance.
Necessary Information
Specimen source and organism identification are required.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Infectious Container, Large (T146)
Specimen Type: Mycobacterium tuberculosis complex isolate growing in pure culture
Container/Tube:
Preferred: Solid slant medium (eg. Middlebrook 7H10, 7H11 or Lowenstein Jensen agar)
Acceptable: Broth medium (eg. Mycobacteria Growth Indicator Tube, 7H9 broth, BACT/ALERT MP or VersaTREK bottle). Note: Broth specimens will require subculture which will delay results.
Specimen Volume:
Solid slant medium: Isolate with visible growth
Broth medium: Greater than or equal to 3 mL of broth culture
Collection Instructions:
1. Organism must be in pure culture, actively growing. Do not submit mixed cultures.
2. Place specimen in a large infectious container and label as an etiologic agent/infectious substance.
3. Turnaround time for results may be delayed if subculture is needed to ensure purity.
Special Instructions
Library of PDFs including pertinent information and forms related to the test
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
See Specimen Required
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Agar plate | Reject |
| Mixed culture | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
Useful For
Suggests clinical disorders or settings where the test may be helpful
Molecular detection of drug resistance variants in culture isolates of the Mycobacterium tuberculosis complex
May provide a more rapid detection of drug resistance than phenotypic, broth-based testing for selected gene targets
Aiding in the resolution of discrepant results obtained using phenotypic methods
Testing for M tuberculosis complex isolates that are not sufficiently viable to allow for culture-based testing
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
Next-Generation sequencing (NGS) of Mycobacterium tuberculosis complex isolates is performed followed by evaluation of selected genes of interest for the presence of well-characterized, drug resistance-conferring variants.
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
An important component of disease management for patients with tuberculosis is testing of Mycobacterium tuberculosis complex isolates for resistance to antituberculous medications. Phenotypic culture-based drug resistance testing is often performed using broth methods since they are more rapid than the agar proportion method. However, even the rapid broth methods require approximately 14 to 21 days.
This targeted next-generation sequencing testing provides molecular detection of well-characterized drug-resistance variants in M tuberculosis complex by sequencing selected genes of interest:
| Drug Name | Genomic Targets |
| Rifampin | rpoB |
| Isoniazid | katG, ahpC, inhA, fabG1 |
| Pyrazinamide | pncA |
| Ethambutol | embB |
| Streptomycin | gidB, rrs, rpsL |
| Fluoroquinolones | gyrA, gyrB |
| Kanamycin | eis, rrs |
| Amikacin | rrs |
| Capreomycin | rrs, tlyA |
| Ethionamide | ethA, inhA, fabG1 |
| Linezolid | rplC, rrl |
| Bedaquiline, Clofazimine | rv0678 |
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Not applicable
Interpretation
Provides information to assist in interpretation of the test results
Variants detected in Mycobacterium tuberculosis complex that are associated with drug resistance according to the World Health Organization (WHO) "Catalogue of mutations in Mycobacterium tuberculosis and their association with drug resistance" are reported.(1)
If no variants associated with drug resistance are detected in the M tuberculosis complex isolate, a "no mutation detected" result is reported.
Genetic variants of unknown significance according to the WHO catalog are also noted.(1)
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
The absence of a genetic variant in this assay does not indicate that the isolate is susceptible to an antimicrobial agent since not all genes in the M tuberculosis complex are queried. Phenotypic susceptibility testing is required.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance. 2nd ed. World Health Organization; 2023. Accessed December 4, 2025. Available at https://www.who.int/publications/i/item/9789240082410
2. Mansoor H, Hirani N, Chavan V, et al. Clinical utility of target-based next-generation sequencing for drug-resistant TB. Int J Tuberc Lung Dis. 2023;27(1):41-48. doi:10.5588/ijtld.22.0138.
3. Jouet A, Gaudin C, Badalato N, et al. Deep amplicon sequencing for culture-free prediction of susceptibility or resistance to 13 anti-tuberculous drugs. Eur Respir J. 2021;57(3):2002338. Published 2021 Mar 18. doi:10.1183/13993003.02338-2020
Method Description
Describes how the test is performed and provides a method-specific reference
Targeted next-generation sequencing is used to detect variants in selected genes of M tuberculosis complex.(Unpublished Mayo method)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
87153 - M tuberculosis drug resistance, NGS
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| DMTBR | M tuberculosis drug resistance, NGS | 94053-6 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| TBSS | Specimen source for culture isolate | 31208-2 |
| TBDI | Organism Identification | 42803-7 |
| 623238 | inhA | 94055-1 |
| 623237 | rpoB | 94065-0 |
| 623239 | fabG1 | 94056-9 |
| 623240 | katG | 94054-4 |
| 623241 | ahpC | 94057-7 |
| 623242 | ethA | 72866-7 |
| 623243 | pncA | 94059-3 |
| 623244 | embB | 94058-5 |
| 623245 | gidB | 94061-9 |
| 623246 | rpsL | 94063-5 |
| 623247 | rrs | 94062-7 |
| 623248 | eis | 94064-3 |
| 623249 | tlyA | In Process |
| 623250 | gyrA | 94060-1 |
| 623251 | gyrB | 101576-7 |
| 623252 | rrl | In Process |
| 623253 | rplC | In Process |
| 623254 | rv0678 | In Process |
| 623255 | rifampin (RIF) Interpretation | 46244-0 |
| 623256 | isoniazid (INH) Interpretation | In Process |
| 623257 | pyrazinamide (PZA) Interpretation | 46245-7 |
| 623258 | ethambutol (EMB) Interpretation | 46247-3 |
| 623259 | streptomycin (SM) Interpretation | In Process |
| 623260 | amikacin (AMI) Interpretation | In Process |
| 623261 | kanamycin (KAN) Interpretation | In Process |
| 623262 | capreomycin (CAP) Interpretation | In Process |
| 623263 | fluoroquinolones (FQ) Interpretation | In Process |
| 623264 | ethionamide (ETH) Interpretation | 72866-7 |
| 623265 | linezolid (LIN) Interpretation | In Process |
| 623266 | bedaquiline (BDQ) Interpretation | In Process |
| 623267 | clofazimine (CFZ) Interpretation | In Process |
| 623508 | Footnotes | 48767-8 |