BCR-ABL1: High Sensitivity Major Breakpoint p210

Abbrev Code:BCRHS   
Order Code:LAB8153Order Name:BCR-ABL1 High Sensitivity Major Breakpoint p210
Methodology:Quantitative PCR
CPT Codes: 81206 x1, G0452 x1
Turnaround Time:Performed Mon-Fri; results are reported in 7-10 days.

Collection Instructions

Specimen:Blood or bone marrow or RNA
Optimal Volume:20 mL blood; 3 mL bone marrow
Minimum\Peds Volume:10 mL blood; 1 mL bone marrow; 50 uL RNA at a concentration of 20 ng/uL.
Container:Yellow (ACD, Solution A) tube available from laboratory
Alternate Containers: Purple (EDTA)
Causes for Rejection:Blood or bone marrow specimen received more than 72 hours from the date of collection; incorrect volume or tube type; clotted or frozen specimens; RNA not shipped on dry ice. RNA extracted at non-CLIA certified (or equivalent) LAB. Shared samples will not be accepted unless sent to Molecular first. Contamination will occur on automated hematology analyzers.

Processing and Shipping

Specimen Processing:Store blood or bone marrow in refrigerator. Store RNA on dry ice.
Shipping Instructions:Ship blood or bone marrow at refrigerated temperature to arrive within 24 hours of collection, Mon-Fri only. See Cause for Rejection. Ship RNA on dry ice. If shipping on Thursday or Friday, contact lab at 612-273-8445.
Test Performed at or Referral Lab UM Molecular Diagnostics (M)  (UMMC East Bank)


Reference Range:See interpretive report.
Use:High sensitivity BCR/ABL1 testing (4.5 log reduction) is important to define CML patients who have had a deep molecular response to tyrosine kinase therapy. Patients with deep molecular response may remain in sustained remission when treatment is withdrawn, therefore deep molecular response must be confirmed before considering withdrawal of tyrosine kinase inhibitor therapy. This testing aids in the decision to discontinue TKI therapy and should only be tested in patients who have had negative p210 BCR/ABL1 testing by the standard method and are being considered for discontinuation of therapy.

Cases with BCR-ABL1/ABL1 ratios >0.1% may be followed by standard quantitative BCR-ABL1 testing, MR3 (EPIC test code LAB4751) and may not require high sensitivity testing until standard testing becomes negative.

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