Mycobacterium tuberculosis Complex, PCR, Non-Respiratory

Test Code

30277

CPT Codes
87556

Preferred Specimen

1 mL CSF, gastric lavage, pericardial fluid, peritoneal fluid, pleural fluid, synovial fluid, abscess fluid or urine collected in a sterile plastic leak-proof container or
1 mL whole blood collected in an EDTA (lavender-top) tube or
2 grams fresh (unfixed) tissue collected in a sterile plastic leak-proof container, or with a small amount of saline with no fixative or preservatives.

Minimum Volume

0.5 mL (0.2 mL vitreous eye fluid, 2 gm tissue)

Other Acceptable Specimens

0.5 mL vitreous (eye) fluid in a sterile leak-proof container

Instructions

Gastric lavage: Sterile leak-proof container. Must be neutralized with sodium bicarbonate within 4 hours of collection and store refrigerated.

Tissue: Fresh (unfixed) tissue submitted in a sterile, plastic, leak-proof container or Fresh (unfixed) tissue in a sterile plastic leak-proof container with a small amount of saline with no fixatives or preservatives and store refrigerated or frozen.

Transport Temperature

Vitreous (eye) fluid: Frozen
All other samples: Refrigerated (cold packs)

Specimen Stability

Vitreous (eye) fluid
Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days

All other samples
Room temperature: 48 hours
Refrigerated: 14 days
Frozen: 30 days

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

Sputum • Specimen received in formalin and/or alcohol • Processed/concentrated specimen from client • Swabs • Paraffin embedded (FFPE) tissue • Culture isolates • Non-neutralized gastric lavage

Methodology
Real-Time Polymerase Chain Reaction

FDA Status
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: 1-3 days

Clinical Significance

Used to aid the physician in the rapid diagnosis and treatment of a possible tuberculosis infection.

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.