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

Test Summary

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).

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

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 of 10 ng/uL extracted RNA

Instructions

Do not reject specimens, send to laboratory for screening.

Collect 5 mL of 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 cancelation of test may occur. Clotted specimens are unacceptable.

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.


Patient Preparation

N/A

Storage

N/A

Transport Temperature

Whole blood or bone marrow: Room temperature
Extracted RNA: Refrigerated (cold packs)

Specimen Stability

  • Whole blood and Bone marrow
  • Room temperature: 5 days
  • Refrigerated: 5 days
  • Frozen: Unacceptable
  • Extracted RNA
  • Room temperature: Unacceptable
  • Refrigerated: Preferred
  • Frozen: Acceptable

Limitations

N/A

Other Acceptable Specimens

Whole blood or bone marrow collected in: EDTA (royal blue-top) tube, or lithium heparin or sodium heparin (green-top) tube • 50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube

Unacceptable Specimens

N/A

Order Code

CBFBMY

EPIC (Premier) Code

LAB6317

Includes

N/A

CPT Code

  • 81401

Billing Code

  • 670633

CPT Statement

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. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

Negative

Setup Schedule / Expected Turnaround Time

Tuesday; Report available: 6 days

Specimen Collection

Special Instructions

N/A

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 of 10 ng/uL extracted RNA

Instructions

Do not reject specimens, send to laboratory for screening.

Collect 5 mL of 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 cancelation of test may occur. Clotted specimens are unacceptable.

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.


Patient Preparation

N/A

Storage

N/A

Transport Temperature

Whole blood or bone marrow: Room temperature
Extracted RNA: Refrigerated (cold packs)

Specimen Stability

  • Whole blood and Bone marrow
  • Room temperature: 5 days
  • Refrigerated: 5 days
  • Frozen: Unacceptable
  • Extracted RNA
  • Room temperature: Unacceptable
  • Refrigerated: Preferred
  • Frozen: Acceptable

Limitations

N/A

Other Acceptable Specimens

Whole blood or bone marrow collected in: EDTA (royal blue-top) tube, or lithium heparin or sodium heparin (green-top) tube • 50 uL of 10 ng/uL extracted RNA submitted in a microcentrifuge tube

Unacceptable Specimens

N/A

Billing

CPT Code

  • 81401

Billing Code

  • 670633

CPT Statement

Result Information

Methodology

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

Testing Laboratory

N/A

Reference Range

Negative

Setup Schedule / Expected Turnaround Time

Tuesday; Report available: 6 days