Mycobacterium tuberculosis Complex, PCR, Culture and Smear, Non-Respiratory

Test Code

LAB234038

Quest Code

14685

CPT Codes
87116, 87206, 87556

Includes

Mycobacteria, Culture, with Fluorochrome Smear
Mycobacterium tuberculosis Complex, PCR, Non-Respiratory

An additional charge for Concentration (CPT code(s): 87015) will be added as appropriate.

Identification will be performed at an additional charge for each organism
CPT code(s) 87118: Matrix Assisted Laser Desorption/Ionization-Time of Flight or
CPT code(s) 87153: AFB Sequencing

If TB is isolated for the first time or after three months after the first isolate from a patient, susceptibilities will be performed at an additional charge (CPT code(s) 87190 per drug).

Preferred Specimen

10 mL body fluids or gastric lavage or
2 mL CSF or
2 grams fresh (unfixed) tissue or
40 mL urine collected in a sterile leak-proof container or
1 mL exudate, aspirate, or lesion material collected in a sterile leak-proof container

Patient Preparation
See individual tests

Minimum Volume

2 mL body fluids or gastric lavage • 1 mL CSF • 1 gram fresh (unfixed) tissue • 20 mL urine • 1 mL exudate, aspirate, lesion material

Instructions

Tissue and biopsy material: Sterile leak-proof container with small amount of saline, no fixative or preservative.
Gastric lavage fluid: Sterile leak-proof container. Must be neutralized with sodium bicarbonate within 4 hours of collection.

See the alphabetical listing in the Microbiology section of Specimen Collection & Transport Guide for further instructions.

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 5 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimens received in formalin and/or alcohol • Sputum • Processed/concentrated specimen from client • Vitreous (eye) fluid • Stool • Swabs

Methodology
Continuous Monitoring Broth Culture System and Conventional Culture • Microscopic Exam with Fluorochrome Stain • Real-Time Polymerase Chain Reaction

FDA Status
Mycobacterium tuberculosis Complex, PCR, Non-Respiratory: This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes. This test should not be used for diagnosis without confirmation by other medically established means.

Setup Schedule

Set up: Daily; Report available: 50-51 days

Reference Range

See Laboratory Report

Clinical Significance

There are more than 70 species of Mycobacteria of which the primary pathogen is M. tuberculosis. Tuberculosis is a chronic, granulomatous disease caused by M. tuberculosis. Identification, and, if appropriate, antibiotic sensitivity, is required to initiate necessary therapy.

Performing Laboratory

Quest Diagnostics Nichols Institute

33608 Ortega Highway

San Juan Capistrano, CA 92675-2042

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.