Test Code LAB7356 Mycobacterium tuberculosis PCR
Methodology
Methodology
The Xpert MTB/RIF Assay, performed on the GeneXpert Instrument Systems, is a qualitative, nested real-time polymerase chain reaction (PCR) diagnostic test for the detection of Mycobacterium tuberculosis complex DNA.
Testing Algorithm:
- PCR for Mycobacterium tuberculosis complex (MTBC) will be performed on respiratory related specimens (i.e. bronchial alveolar lavage, bronchial washing, induced sputum, sputum, tracheal aspirate, or plueral fluid) on positive acid-fast stain or when specifically ordered.
- Mycobacteriology (AFB) culture will also be performed on all specimens submitted for Mycobacterium tuberculosis PCR
Specimen Requirements
Acceptable Specimens:
Bronchial or tracheal: >5 mL in a leakproof, screw-capped, sterile container.
Sputum: >5 mL in a leakproof, screw-capped, sterile container.
Plueral fluid: >5 mL in a leakproof, screw-capped, sterile container.
Collection procedure:
Note: Specimen source is required.
Broncheal or Tracheal
- Aseptically collect >5 mL of fluid.
- Place in a leakproof, screw-capped, sterile container.
- Maintain sterility and transport promptly to laboratory.
- If transport is delayed, refrigerate specimen.
Pleural fluid
- Aseptically collect >5 mL of fluid.
- Place specimen in a leakproof, screw-capped, sterile container.
- Maintain sterility and transport promptly to laboratory.
- If transport is delayed, keep specimen at room temperature.
Sputum
- Aseptically collect early morning specimen in a leakproof, screw-capped, sterile container. It is optimal to collect a specimen each day for 3 consecutive days. (Note: Saliva is NOT acceptable)
- Instruct patient to brush his/her teeth and rinse mouth with water.
- Have patient remove any dentures.
- Instruct patient to take a deep breath, hold momentarily, then cough deeply and vigoroursly into leakproof, screw-capped, sterile container. Collect >5 mL of discharged material.
- Maintain sterility and transport promptly to laboratory.
- If transport is delayed, refrigerate specimen.
Day(s) Test Set Up
Monday through Sunday
Cutoff time for same day results: 1600
Turnaround Time:
STAT: Not available
Routine: 24 hours
Reference Values
Mycobacterium tuberculosis Complex Not Detected.
Literature Reference:
Della-Latta P., Mycobacteriology and Antimycobacterial Susceptibility Testing. In: Leber, Amy, ed. Clinical microbiology procedures handbook. 4th ed. Washington DC: American Society for Microbiology; 2016:7.6.
Specimen Transport Temperature
Ambient/Refrigerate OK
Additional Information
For BJH Laboratory Use Only
Minimum volume: 1.5 mL
Test performed in BJH Microbiology
Test Classification and CPT Codes
87556 - Infectious agent detection by nucleic acid (DNA or RNA): Mycobacterium tuberculosis, amplified probe technique
87116 - Culture, Mycobacterium
87206 - Smear fluorescent, acid-fast (if appropriate)