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

Method Name

Real-Time Polymerase Chain Reaction (PCR)

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:

Supplies: Tissue Block Container (T553)

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

Sources: Body tissue

Container/Tube: Tissue block

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

 

Acceptable:

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

Sources: Body tissue

Container/Tube: Sterile containers, one for each individual cut section (scroll).

Collection Instructions:

1. Perform microtomy and prepare five separate 10-micron sections.

2. Place each section (scroll) in a separate sterile container for submission.


Specimen Minimum Volume

See Specimen Required.

Specimen Stability Information

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

Reject Due To

Any non-formalin-fixed, paraffin-embedded tissue block (FFPE)
FFPE slides
FFPE body fluids
Reject

Clinical Information

Each year, Mycobacterium tuberculosis accounts for more than a million deaths and is responsible for millions of newly diagnosed cases of tuberculosis worldwide. M tuberculosis is spread from person-to-person via respiratory transmission and has the potential to become resistant to many or all antibiotics currently used if antimycobacterial treatment is not promptly initiated. Therefore, rapid and accurate detection of M tuberculosis in patient specimens is of clinical and public health importance.

 

Conventional culture methods can generally detect M tuberculosis in 2 to 3 weeks, although up to 8 weeks of incubation may be required in some instances. Developed at Mayo Clinic, this rapid polymerase chain reaction (PCR) assay detects M tuberculosis complex DNA directly from specimens without waiting for growth in culture and, therefore, the results are available rapidly after receipt in the laboratory. A mycobacterial culture must always be performed in addition to the PCR assay. The PCR assay is rapid, but culture has increased sensitivity over the PCR assay. The PCR assay targets a unique sequence within the katG gene, which is present in members of the M tuberculosis complex. In addition, the assay can detect genotypic resistance to isoniazid mediated by mutations in the katG target, when present.

Reference Values

Not applicable

Day(s) Performed

Monday through Sunday

Report Available

5 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87556