BCR/ABL1, p210, Quant

Test Code: BCRABL-NAT

Overview
Ordering
Specimen
Performing
Clinical/Interpretive
Contacts
Coding

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

Useful For

MONITORING response to therapy in patients with chronic myeloid leukemia who are known to have the e13/a2 or e14/a2 BCR/ABL 1 fusion transcript forms

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

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 or other BCR/ABL1-positive neoplasm

2. Date of collection

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

Acceptable Specimen Types

Whole Blood

Specimen Stability Information

Specimen Type	Temperature	Time
Whole Blood	Refrigerated	72 hours

Rejection Criteria

Gross Hemolysis

Incorrect collection tube

>72 hours old

Clotted specimens

Performing Laboratory 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)

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.

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.

Interpretation

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.

Outreach CPTs

CPT	Modifier (if needed)	Quantity	Description	Comments
81206