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Mycobacterium tuberculosis Complex, Molecular Detection, PCR, Varies
Test Code39804
CPT Codes
87556<br><strong>Restricted Client Code</strong>
Preferred Specimen
1 mL body fluid, or bone marrow aspirate, ocular, or CSF collected in a sterile container, or
2 mL gastric washing collected in a sterile container, or
1 mL respiratory (BAL, bronchial washing, or sputum) collected in a sterile container, or
5-10 grams feces submitted in a sterile container, or
5-10 mm tissue (fresh tissue, bone, or bone marrow biopsy) submitted in a sterile container, or
1 mL random urine collected in a sterile container
2 mL gastric washing collected in a sterile container, or
1 mL respiratory (BAL, bronchial washing, or sputum) collected in a sterile container, or
5-10 grams feces submitted in a sterile container, or
5-10 mm tissue (fresh tissue, bone, or bone marrow biopsy) submitted in a sterile container, or
1 mL random urine collected in a sterile container
Minimum Volume
0.5 mL body fluids, bone marrow aspirate, ocular, CSF, respiratory fluids, urine
1 mL gastric washing
5 grams feces
5 mm tissue
1 mL NALC/NaOH digested respiratory specimens
1 mL gastric washing
5 grams feces
5 mm tissue
1 mL NALC/NaOH digested respiratory specimens
Other Acceptable Specimens
2 mL NALC/NaOH-digested respiratory specimens (Lavage fluid, bronchial washing, gastric washing, respiratory fluid, sputum, or tracheal secretion) collected in a sterile container
Instructions
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.
This test should always be performed in conjunction with mycobacterial culture.
Specimen source is required.
For body fluid: Only fresh, non-NALC/NaOH-digested body fluid is acceptable
For Gastric Washing: Neutralize specimen within 4 hours of collection with 20 mg of sodium carbonate per 2 mL of gastric washing.
For Feces: Only fresh, non-NALC/NaOH-digested fecal specimens are acceptable.
For tissue: Keep moist with sterile water or sterile saline. Only fresh, non-NALC/NaOH-digested tissue is acceptable.
For NALC/NaOH-digested respiratory specimens:
1. Submit digested specimen treated with NALC/NaOH.
2. Clearly indicate on container and order form that specimen is a digested specimen.
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.
This test should always be performed in conjunction with mycobacterial culture.
Specimen source is required.
For body fluid: Only fresh, non-NALC/NaOH-digested body fluid is acceptable
For Gastric Washing: Neutralize specimen within 4 hours of collection with 20 mg of sodium carbonate per 2 mL of gastric washing.
For Feces: Only fresh, non-NALC/NaOH-digested fecal specimens are acceptable.
For tissue: Keep moist with sterile water or sterile saline. Only fresh, non-NALC/NaOH-digested tissue is acceptable.
For NALC/NaOH-digested respiratory specimens:
1. Submit digested specimen treated with NALC/NaOH.
2. Clearly indicate on container and order form that specimen is a digested specimen.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 7 days
Refrigerated: 7 days
Frozen: 7 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Blood specimen in anaerobe vial or viral transport medium (including but not limited to M4, M5, BD viral transport media, thioglycolate broth) • Swab tissues in formalin fluid
Methodology
Real-Time Polymerase Chain Reaction (PCR)
FDA Status
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U. S. Food and Drug Administration.
Setup Schedule
Set up: Daily; Report available: 1-3 days
Reference Range
See Laboratory Report
Clinical Significance
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).
