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


Abbrev Code:BCABL1   
Order Code:LAB6901Order Name:BCR/ABL 1 Mutation Analysis
Methodology:Massively parallel sequencing
CPT Codes: 81170 x1
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. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.



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
Container:Purple (EDTA)
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.
Stability:Stability: 1 hour at room temperature; 48 hours at refrigerated temperature.
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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