Laboratory Services

Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Varies

Name: Incyte Diagnostics
Address: 13103 E Mansfield Ave, Spokane Valley, Washington, 99216, USA
Telephone: +1-

Updated Test Information:

Test Description	Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Varies
Synonym(s)	AFB, Acid-Fast Bacilli, Bacillus Acid Fast, MTB, Mycobacterium tuberculosis, TB, tuberculosis
Test ID	MTBRP
General Information	Rapid detection of Mycobacterium tuberculosis complex DNA, preferred method Detection of M tuberculosis, when used in conjunction with mycobacterial culture 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 (TST/PPD) or an interferon gamma release assay (IGRA).
Specimen Type	Submit only 1 of the following specimens: 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 fluid is 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, or sputum Container/Tube: Sterile container Specimen Volume: 1 mL if only PCR ordered or 3 mL if PCR ordered with smear and culture Specimen Type: Feces Container/Tube: Sterile container Specimen Volume: 5-10 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: 5-10 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 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 Requirements	The high sensitivity of amplification by 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. Preferred Specimens: Body fluid, cerebrospinal fluid (CSF), ocular fluid, respiratory (eg, bronchoalveolar lavage [BAL], bronchial washing, sputum), feces, fresh tissue, bone, bone marrow, or urine Acceptable Specimens: If no fresh specimen is available, digested respiratory specimens treated with N-acetyl-L-cysteine/sodium hydroxide (NALC/NaOH) are acceptable (eg, BAL, bronchial washing, respiratory fluid, sputum, or tracheal secretion), as are NALC/NaOH-treated gastric washings.
Specimen Collection / Processing Instructions	Specimen must arrive within 7 days of collection; specimen >7 days will be rejected. Specimen source is required.
Minimum Sample Volume	Body fluid: 0.5 mL Respiratory specimen-nondigested: 0.5 mL Fresh tissue or bone: 5 mm NALC-NaOH-digested specimen: 1 mL Gastric washing: 1 mL Stool: 5 g Urine: 0.5 mL
Stability	Refrigerated (preferred): 7 days Frozen: 7 days
Unacceptable Specimen Conditions	Blood Specimen in anaerobe vial or viral transport medium (including but not limited to M4, M5, BD viral transport media, thioglycolate broth) Swabs Tissues in formalin fluid
Methodology	Real-Time Polymerase Chain Reaction (PCR)
Estimated TAT	1-3 days
Testing Schedule	Monday - Sunday
CPT Code(s)	87556-Mycobacterium tuberculosis, complex, molecular detection, PCR 87015-Mycobacteria culture, concentration (if appropriate)
Reference Range	A positive result indicates the presence of Mycobacterium tuberculosis complex DNA. Members of the M tuberculosis complex detected by this assay include M tuberculosis, M bovis, M bovis bacillus Calmette-Guerin (BCG), M africanum, M canettii, and M microti. Other species within the M tuberculosis complex (eg, M caprae, M pinnipedii, and M mungi) should, in theory, be detected using the primer and probe sequences in this assay, but they have not been tested. 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.
Reflex Conditions	TBT (concentration, Mycobacteria)
Performing Lab	Mayo
LOINC Code(s)	31208-2, 38379-4
Additional Information	MTBRP Overview