Mycobacterium tuberculosis Complex and Rifampin Resistance, PCR, Sputum

Test Code
94577


CPT Codes
87801

Preferred Specimen
5 mL sputum collected in a sterile leak-proof container


Minimum Volume
2 mL


Instructions
Expectorated sputum: Instruct patient to gargle with water and cough deeply.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: Unacceptable
Refrigerated: 5 days
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Specimen received in formalin and/or alcohol • 24-hour pooled sputum • Samples with obvious food particles or solid particulate • Processed/concentrated sputum specimen from client


Methodology
Real-Time Polymerase Chain Reaction

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.

Active pulmonary TB is a highly infectious airborne disease. All patients in healthcare facilities with suspected TB should be maintained in respiratory isolation according to recommended infection control guidelines. Patients with HIV infection and pulmonary TB are more likely to have sputum samples that are acid-fast bacilli (AFB) smear negative than patients with pulmonary TB alone. Overall rates of detection of MTB-complex with the Xpert (TM) MTB/RIF Assay may be lower in settings with a high percentage of HIV-infected patients relative to populations where the percentage of patients with HIV infection is lower and AFB smear-positive TB is higher.


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



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.