BCR ABL1 CML/ALL PCR, quant

Alphabetical Test listing

BCR ABL1 CML/ALL PCR, quant-13551

  
BCR ABL1 CML/ALL PCR, quant
  
13551
  
LAB13551
  
BCRABL
  
Acute Lymphocytic Leukemia (ALL)
BCR/ABL
BCR-ABL1
Chronic myelogenous leukemia (CML)
p210
p190
BCR-ABL1 Transcript Detection
  

This assay can detect three different types of BCR-ABL1 fusion transcripts associated with CML, ALL, and AML:

  • e13a2 (previously b2a2) and
  • e14a2 (previously b3a2) (major breakpoint, p210)
  • e1a2 (minor breakpoint, p190)
  
EDTA whole blood
  
  
5.0 mL
  
3.0 mL
  

Immediately after collection, mix tube thoroughly by gentle inversion, 8 - 10 times, to prevent clotting

  

Lavender (EDTA), 4mL

  
Sodium heparin (Na hep) whole blood
ACD-A whole blood
Bone marrow
Cell pellet
  
  

Bone marrow - 2.0mL (minimum 1.0 mL)
  

Dk green Sodium heparin (Na hep), no gel

Yellow ACD-A

  

Molecular Medicare billing request

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.

  

Ambient (preferred) - 48 hours

Refrigerated - >48 hours

  
  • Specimen does not meet collection criteria
  • Frozen whole blood or marrow
  • Leaking tube
  • Clotted blood or marrow
  • Grossly hemolyzed
  • Otherwise visibly degraded
  • Contamination by another specimen
  • Containing suspicious foreign material
  • PCR testing cannot be added on to a sample that has been opened and/or used for other testing. If the sample has already been used for testing, a new specimen will need to be collected.
  
LabCorp RTP (480481): R-LC
  
Su - Fr
  
5 - 10 days
  

Total RNA is isolated from the sample and subject to a real-time, reverse transcriptase polymerase chain reaction (RT-PCR). The PCR primers and probes are specific for BCR-ABL1 e13a2, e14a2 and e1a2 fusion transcripts. The ABL1 transcript is amplified as the control for cDNA quantity and quality. Serial dilutions of a validated positive control RNA with known t(9;22) BCR-ABL1 are used as reference for quantification of BCR-ABL1 relative to ABL1. The numeric BCR-ABL1 level is reported as % BCR-ABL1/ABL1 and the detection sensitivity is 4.5 log below the standard baseline (<0.0032%).

  

An interpretive report will be included

  

The e13a2 and e14a2 transcript values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABL1 (IS) and major molecular response (MMR) is equivalent to 0.1% BCR-ABL1 (IS) corresponding to a 3-log reduction. Results should be correlated with appropriate clinical and laboratory information as indicated.

  
This test may require preauthorization from the insurance provider. Check the payer guidelines and, if needed, obtain the pre-authorization prior to sample collection.
  
81206
81207
  
Yes
  

Medical necessity

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medicare billing request form to notify us of the need for Allina Health Laboratory to bill insurance.

Molecular Medicare billing request

  
03/27/2019
  
05/15/2024
  
01/02/2024