ABL Kinase Domain Mutation

ABL Kinase Domain Mutation

Test Code

16029
81170
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16029
81170
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

ABL Kinase Domain Mutation - Kinase inhibitors such as IMATINIB mesylate (ST1571;GLEEVEC) are effective in the treatment of chronic Myelogenous Leukemia (CML) by selectively inhibiting BCR-ABL fusion protein. Most patients in chronic phase maintain durable responses; however, many in blast crisis fail to respond, or relapse quickly. ABL kinase domain mutations are the most identified mechanism associated with relapse. The molecular monitoring in the first few months of therapy may play a crucial role in detecting patients at high risk of resistance to therapy. The ABL kinase mutation assay sequences exons 4-9 of ABL1 kinase ...

Test Resources

Test FAQ

ABL Kinase Domain Mutation in CML, Cell-based

Algorithm

Use of Laboratory Tests to Monitor Response to TKI Therapy in CML Patients

Algorithm

Uses of ABL1 Kinase Domain Mutation Analysis

Test Guide

Chronic Myeloid Leukemia: Laboratory Evaluation

Test Details

Methodology

Real-Time Polymerase Chain Reaction • Nested Polymerase Chain Reaction • Sequencing

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 FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Not Detected

Alternative Name(s)

ABL Mutation

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Real-Time Polymerase Chain Reaction • Nested Polymerase Chain Reaction • Sequencing
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Not Detected

Alternative Name(s)

ABL Mutation
Service Area must be determined

Preferred Specimen(s)

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

Alternative Specimen(s)

Whole blood collected in: Sodium heparin (green-top) tube or ACD solution B (yellow-top) tube • Bone marrow aspirate collected in: Sodium heparin (green-top) tube

Minimum Volume

3 mL whole blood • 1 mL bone marrow

Collection Instructions

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. Ship sample immediately due to short sample stability of 72 hours.
⁠⁠⁠⁠⁠⁠⁠If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.

Do not reject specimens, send to laboratory for screening.

Transport Container

EDTA (lavender-top) tube

Transport Temperature

Refrigerated (cold packs)

Specimen Stability

  • Room temperature: 72 hours
  • Refrigerated: 72 hours
  • Frozen: Unacceptable

Setup Schedule

Service Area must be determined
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube
Whole blood collected in: Sodium heparin (green-top) tube or ACD solution B (yellow-top) tube • Bone marrow aspirate collected in: Sodium heparin (green-top) tube
3 mL whole blood • 1 mL 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. Ship sample immediately due to short sample stability of 72 hours.
⁠⁠⁠⁠⁠⁠⁠If the stability of the sample cannot be determined, delay in result or cancellation of test may occur.

Do not reject specimens, send to laboratory for screening.
EDTA (lavender-top) tube
Refrigerated (cold packs)
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: Unacceptable
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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