CBFB/MYH11 inv(16), Quantitative, Real-Time PCR

Test Code

14992

CPT Codes
81401

Preferred Specimen

5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube

Minimum Volume

2 mL whole blood
1 mL bone marrow
20 uL extracted RNA

Other Acceptable Specimens

Whole blood or bone marrow collected in: EDTA (royal blue-top) tube, lithium heparin (green-top) tube or sodium heparin (green-top) tube

50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube

Instructions:
Only accept extracted RNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or CMS.

Instructions

Do not reject specimens, send to laboratory for screening. Collect 5 mL whole blood or 3 mL bone marrow in an EDTA (lavender-top) tube. Whole blood or bone marrow is shipped at room temperature or refrigerated (cold packs). Do not freeze whole blood or bone marrow. After collection of the sample, draw date and time, as well as sample type, must be written on the tube and included as requested information. If the stability of the sample cannot be determined, delay in result or cancellation of test may occur. Clotted specimens are unacceptable.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Room temperature

Specimen Stability

Whole blood & bone marrow:
Room temperature: 5 days
Refrigerated: 5 days
Frozen: Unacceptable

Extracted RNA:
Room temperature: Unacceptable
Refrigerated: Preferred
Frozen: Acceptable

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

Gross hemolysis • Clotted blood

Methodology
Real-Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)

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.

Setup Schedule

Mon

Reference Range

Negative

Clinical Significance

This Real-Time Quantitative (Reverse Transcription Polymerase Chain Reaction) for the amplification of CBFB/MYH11 fusion transcript can be used to detect the chromosome aberration of inv (16) or t (16;16). It can be used to detect Minimal Residual Disease (MRD) and assess the risk for disease relapse in inv (16) or t (16;16) Acute Myeloid Leukemia (AML).

Performing Laboratory

Quest Diagnostics Nichols Institute-San Juan Capistrano, CA

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.