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Test Code BCRABL-NAT BCR/ABL1, p210, Quant

Useful For

Monitoring the response of therapy in patients with CML who are known to harbor the e13/a2 or e14/a2 fusions forms, which produces the p210 protein.

 

This test SHOULD NOT be used for diagnostic screening of BCR/ABL1 fusions translocation rearrangements. Please order MISC and comment BCRFXSO for diagnostic screening.

Synonyms/Keywords

BCR-ABL1
BCR ABL
BCR/ABL
Chronic myelogenous leukemia (CML)
Philadelphia chromosome, Ph bone marrow/blood
t(9;22)
Tyrosine kinase inhibitor (TKI) therapy monitoring, PCR

Specimen Requirements

Fasting Required Specimen Type Preferred Container/Tube Acceptable Container/Tube Specimen Volume Specimen Minimum Volume
(allows for 1 repeat)
Pediatric Minimum Volume
(no repeat)
No Whole Blood EDTA Lavender Top Tube (LTT)
 
10 mL 8 mL  

Acceptable Specimen Types

Whole Blood

Collection/Processing Instructions

*Due to short sample stability, DO NOT collect at a regional center on a Friday.  If collected in Marshfield on Friday, only an AM morning draw is acceptable. Samples must reach the Marshfield Lab by 11am. 

 

Specimen MUST ARRIVE within 72 hours of collection. Collect and package specimen as close to shipping time as possible. Specimens greater than 3 days old at the time of receipt will be considered unacceptable.

 

The following information is required:

1. Pertinent clinical history including if the patient has a diagnosis of chronic myeloid leukemia with the p210 fusion protein transcript.

2. Accompanying CBC results (≤ 48 hours from collection of BCR/ABL sample).

3. Date of collection

 

**For bone marrow specimens, order as MISC and comment BCRAB to Mayo Clinic Laboratories.** 

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood Refrigerated 72 hours

Rejection Criteria

Gross Hemolysis

Incorrect collection tube

>72 hours old

Clotted specimens

Interpretations

 An interpretive report will be provided. When BCR/ABL1 mRNA is present, quantitative results are reported on the international scale (IS), established from data originally reported in the IRIS (International Randomized Study of Interferon versus STI571) trial involving newly diagnosed chronic myeloid leukemia patients. Using the IS, a result of less than 0.1% BCR/ABL1 (p210):ABL1 is equivalent to a major molecular remission. This value is also designated on a log scale (Molecular Response, MR) as MR3. For further discussion of the international scale, see Clinical References.

Reference Range Information

Performing Location Reference Range
Marshfield Laboratories The presence or absence of BCR/ABL1 mRNA fusion form e13/e14-a2 producing the p210 fusion protein is identified. If positive, the quantitative level is reported as the normalized ratio of BCR/ABL1 (p210) to endogenous ABL1 mRNA with conversion to a percentage referenced to the international scale (IS), on which 0.1% BCR/ABL1:ABL1 (also represented on a log scale as Molecular Response 3, or MR3) is designated as a major molecular response (MMR) threshold.

Marshfield Labs Performing Department

Marshfield Labs Molecular Pathology

Performing Information

Performing Location Day(s) Test Performed Analytical Time Methodology/Instrumentation
 
Marshfield Monday through Friday 1 day Quantitative Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

CPT Codes

CPT Modifier
(if needed)
Quantity Description Comments
 
81206        

Outreach CPT Codes

CPT Modifier
(if needed)
Quantity Description Comments
 
81206        

Ordering Applications

Ordering Application Description
 
Cerner BCR/ABL1, p210 , Quant