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

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

Test Code

14992
81401
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
14992
81401
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

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

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).

Test Resources

None found for this test
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Test Details

Methodology

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

Assay Category

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.

Reference Range(s)

Negative

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

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

Reference Range(s)

Negative
Service Area must be determined

Preferred Specimen(s)

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

Alternative Specimen(s)

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.

Minimum Volume

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

Collection 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

Gross hemolysis • Clotted blood

Setup Schedule

Service Area must be determined
5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube

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.

2 mL whole blood
1 mL bone marrow
20 uL extracted RNA
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.
EDTA (lavender-top) tube
Room temperature

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

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

Gross hemolysis • Clotted blood
Service Area must be determined
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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