BCR/ABL1, Mutation Analysis for Tyrosine Kinase Inhibitor Resistance by Next Generation Sequencing-Time Sensitive Special Handling Required


Sunquest Code:BCABL1  
Epic Code:LAB6901Epic Name:BCR/ABL 1 Mutation Analysis
Methodology:Massively parallel sequencing
CPT Code:81170
Turnaround Time:Specimens are sent to reference laboratory Mon-Sat; results are reported within 10-12 days.
Special Instructions:

Sample must be refrigerated within 1 hour of collection and arrive at testing site within 48 hours of collection.

 

Compliance:

This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.



Collection Instructions

Specimen:Blood or bone marrow
Optimal Volume:5 mL blood or 3 mL bone marrow
Minimum\Peds Volume:1 mL blood or bone marrow
Causes for Rejection:Serum or plasma. Specimens collected in anticoagulants other than EDTA. Frozen specimens. Clotted or severely hemolyzed specimens.


Processing and Shipping

Specimen Processing:Do not process. Refrigerate within 1 hour of collection.
Shipping Instructions:Ship at refrigerated temperature to arrive within 48 hours of collection.
Test Performed at or Referral Lab Lab Sendouts  (ARUP)
Referral Lab number:2008420


Interpretive

Reference Range:By report.
Use:Order only for patients with an established diagnosis of a BCR-ABL1 positive leukemia. This test is used to determine if a mutation is present that would interfere with response to TKI therapy in Philadelphia chromosome positive (Ph+) lymphoblastic leukemia or chronic myelogenous leukemia (CML). This test detects all common mutations, including T315I.


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