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Test Code LAB1356 Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Varies

Additional Codes

MTBRP

47153

Reporting Name

M tuberculosis Complex PCR

Useful For

Rapid detection of Mycobacterium tuberculosis complex DNA (preferred method)

 

Detection of M tuberculosis, when used in conjunction with mycobacterial culture

 

This test does not assess M tuberculosis rifampin resistance.

 

This test should not be used to determine bacteriologic cure or to monitor response to therapy.

 

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.

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Varies


Ordering Guidance


This test does not provide rifampin resistance information and is most useful for non-sputum specimens. For sputum specimens, the recommended test is MTBXS / Mycobacterium tuberculosis complex, Molecular Detection and Rifampin Resistance, PCR, Sputum. MTBXS provides rapid resistance information to aid with patient management.



Additional Testing Requirements


This test must always be performed in conjunction with mycobacterial culture. If your facility is unable to perform mycobacterial culture, order CTB / Mycobacteria and Nocardia Culture, Varies concurrently with this test.



Shipping Instructions


Specimen must arrive within 7 days of collection; if greater than 7 days of collection, the specimen will be rejected.



Necessary Information


Specimen source is required.



Specimen Required


Submit a raw clinical sample (not a culture isolate) for testing.

 

Fresh, undigested specimens are preferred. If no fresh specimen is available, digested respiratory specimens treated with N-acetyl-L-cysteine/sodium hydroxide (NALC/NaOH) are acceptable for some specimen types. For detailed information, see the Specimen Type information below.

 

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

 

If a single specimen is being shared between mycobacteria culture, acid-fast smear, and/or M tuberculosis PCR, a minimum volume of 2 mL for body fluid, 3 mL for respiratory specimen, or a pea-sized piece of tissue should be obtained. Specimen volumes less than indicated may decrease sensitivity of testing. If insufficient volume is submitted, test or tests will be canceled.

 

Submit only 1 of the following specimens:

 

Preferred Specimen Types

 

Specimen Type: Body fluid

Sources: Body, bone marrow aspirate, ocular, or CSF

Container/Tube: Sterile container

Specimen Volume: 1 mL

Additional Information: Only fresh, non-NALC/NaOH-digested body fluids are acceptable.

 

Specimen Type: Gastric washing

Container/Tube: Sterile container

Specimen Volume: 2 mL

Collection Instructions: Neutralize specimen within 4 hours of collection with 20 mg of sodium carbonate per 2 mL of gastric washing.

 

Specimen Type: Respiratory

Sources: BAL, bronchial washing, tracheal secretion, or sputum

Container/Tube: Sterile container

Specimen Volume: 1 mL if only PCR ordered or 3 mL if PCR ordered with smear and culture

Additional Information: Before collecting sputum specimens, see Ordering Guidance

 

Specimen Type: Feces

Container/Tube: Sterile container

Specimen Volume: 5 to 10 g

Additional Information: Only fresh, non-NALC/NaOH-digested fecal specimens are acceptable.

 

Specimen Type: Tissue

Sources: Fresh tissue, bone, or bone marrow biopsy

Container/Tube: Sterile container

Specimen Volume: 5 to 10 mm

Collection Instructions: Keep moist with sterile water or sterile saline

Additional Information: Only fresh, non-NALC/NaOH-digested tissue is acceptable.

 

Specimen Type: Urine

Container/Tube: Sterile container

Specimen Volume: 1 mL

Collection Instructions: Collect a random urine specimen.

 

Acceptable Specimen Types

 

Specimen Type: NALC/NaOH-digested respiratory specimens

Sources: Lavage fluid, bronchial washing, gastric washing, respiratory fluid, sputum, or tracheal secretion

Container/Tube: Sterile container

Specimen Volume: 2 mL

Collection Instructions:

1. Submit digested specimen treated with NALC/NaOH.

2. Clearly indicate on container and order form that specimen is a digested specimen.


Specimen Minimum Volume

Body fluid, nondigested respiratory specimen, urine: 0.5 mL; Fresh tissue or bone: 5 mm; NALC-NaOH-digested specimen, gastric washing: 1 mL; Stool: 5 g

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
  Frozen  7 days

Reference Values

Not applicable

Day(s) Performed

Monday through Sunday

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-Mycobacterium tuberculosis, complex, molecular detection, PCR

87015-Mycobacteria culture, concentration (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
MTBRP M tuberculosis Complex PCR 38379-4

 

Result ID Test Result Name Result LOINC Value
SRC62 MTB Complex PCR, Specimen Source 31208-2
56044 MTB Complex PCR, Result 38379-4

Report Available

1 to 3 days

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TBT Concentration, Mycobacteria No, ( Bill Only) No

Testing Algorithm

When this test is ordered, the reflex test may be performed at an additional charge.

 

For more information see Meningitis/Encephalitis Panel Algorithm.

Method Name

Real-Time Polymerase Chain Reaction (PCR)

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.