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Test Code MTBT Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Paraffin, Tissue

Useful For

Preferred method for rapid detection of Mycobacterium tuberculosis complex DNA in formalin-fixed, paraffin-embedded tissue specimens

 

Detecting M tuberculosis complex

 

This test is not intended for the detection of latent tuberculosis and must not be used as a substitute for tests intended for detection of latent tuberculosis such as the tuberculin skin test or an interferon gamma release assay.

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Reporting Name

MTB complex PCR, FFPE

Specimen Type

Tissue, Paraffin


Additional Testing Requirements


When non-fixed specimen is available, a mycobacterial culture on that specimen must always be performed in addition to this test. If your facility is unable to perform mycobacterial culture, order CTB / Mycobacteria and Nocardia Culture, Varies concurrently with this test.



Necessary Information


Specimen source is required.



Specimen Required


The high sensitivity of amplification by polymerase chain reaction requires the specimen to be processed in an environment in which contamination of the specimen by Mycobacterium tuberculosis DNA is unlikely.

 

Preferred Paraffin-embedded tissue block:

Supplies: Tissue Block Container (T553)

Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)

Sources: Body tissue

Container/Tube: Tissue block

Collection Instructions: Submit a FFPE tissue block to be cut and returned.

 

Acceptable Paraffin-embedded tissue block:

Specimen Type: Formalin-fixed, paraffin-embedded tissue block (FFPE)

Sources: Body tissue

Container/Tube: Sterile container for each individual cut section (scroll).

Collection Instructions: Perform microtomy and prepare five separate 10-micron sections. Each section (scroll) must be placed in a separate sterile container for submission.


Specimen Minimum Volume

See Specimen Required.

Specimen Stability Information

Specimen Type Temperature Time Special Container
Tissue, Paraffin Ambient (preferred)
  Refrigerated 

Reference Values

Not applicable

Interpretation

A positive result indicates the presence of Mycobacterium tuberculosis complex DNA. Members of the M tuberculosis complex detected by this assay include M tuberculosis, Mycobacterium bovis, Mycobacterium bovis bacillus Calmette-Guerin (BCG), Mycobacterium africanum, Mycobacterium canettii, and Mycobacterium microti. The other species within the M tuberculosis complex (eg, Mycobacterium caprae, Mycobacterium pinnipedii, and Mycobacterium mungi) should, in theory, be detected using the primer and probe sequences in this assay, but they have not been tested at this time. This assay method does not distinguish between the species of the M tuberculosis complex.

 

A negative result indicates the absence of detectable M tuberculosis complex DNA.

 

Isoniazid (INH) resistance mediated through a katG variant will be reported when observed but lack of a katG variant does not imply that the isolate is susceptible to INH. There are other genetic loci in addition to katG that can contribute to resistance for this drug.

 

An inhibition result indicates that inhibitors are present in the specimen that could prevent the detection of M tuberculosis DNA. A new specimen can be resubmitted under a new order, if desired.

Clinical Reference

1. Iseman MD: A Clinician's Guide to Tuberculosis. 2nd ed. Lippincott Williams and Wilkins; 2013

2. American Thoracic Society; Centers for Disease Control and Prevention; Infectious Diseases Society of America. Treatment of tuberculosis. MMWR Recomm Rep. 2003 Jun 20;52(RR-11):1-77. Erratum in: MMWR Recomm Rep. 2005 Jan 7;53(51):1203

3. Ortiz-Brizuela E, Menzies D, Behr Mad: Testing and treating Mycobacterium tuberculosis infection. Med Clin North Am. 2022 Nov;106(6):929-947. Doi: 10.1016/j.mcna.2022.08.001

Day(s) Performed

Monday through Sunday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

87556

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MTBT MTB complex PCR, FFPE 38379-4

 

Result ID Test Result Name Result LOINC Value
SRCTB MTB Complex PCR, FFPE, Source 31208-2
TBRR MTB Complex PCR, FFPE, Result 38379-4