Mycobacterium tuberculosis Complex and Rifampin Resistance, PCR, Non-Sputum

Test Code
MBTDD-REF


Quest Code
36925


CPT Codes
87801

Preferred Specimen
5 mL bronchial brush/wash, tracheal aspirate or urine collected in a sterile, leak-proof container


Minimum Volume
3 mL bronchial brush/wash, tracheal aspirate or urine
0.5 mL body fluid, CSF, or tissue


Other Acceptable Specimens
1 mL body fluid, or CSF, or tissue collected in a sterile, leak-proof container


Instructions
For tissue, add a small amount of sterile, non-bacteriostatic saline to container (no fixative or preservative).

For sputum, please order Test Code 94577.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sputum • Specimen received in formalin and/or alcohol • Processed/concentrated specimen from client


Methodology
Real-Time Polymerase Chain Reaction

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Mon-Sat; Report available: Next day


Reference Range
MTB ComplexNot detected
Rifampin ResistanceNot detected


Clinical Significance
Globally, about 2 billion people are infected with MTB. In 2010, 8.8 million people developed active disease and 1.4 million people lost their lives to the illness. There were 9951 new cases of tuberculosis reported in the United States in 2012 (a rate of 3.2 cases per 100,000). In 2011, 536 deaths were attributed to tuberculosis infections.

Standard treatment regimens for tuberculosis involve prolonged administration of multiple drugs and is usually highly effective. However, MTB-complex strains that are resistant to one or more of first line drugs require individualized treatment. Rifampin resistance is often an indication of multidrug resistance to tuberculosis (MDR TB), which is defined as resistance to at least rifampin (RIF) and isoniazid (INH). In the Unites States overall RIF resistance is approximately 1.8% with approximately 90% of these strains resistant to at least RIF and INH.


Performing Laboratory
Quest Diagnostics Nichols Institute Chantilly
14225 Newbrook Dr
Chantilly, VA 20153


Last Updated: July 22, 2019


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.