BCR-ABL1 Transcript Detection for Chronic Myelogenous Leukemia (CML) and Acute Lymphocytic Leukemia (ALL), Quantitative

CPT: 81206; 81207
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Test Details

Synonyms

  • Acute Lymphocytic Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative
  • Chronic Myelogenous Leukemia, BCR-ABL1 Transcript Detection by RT-PCR, Quantitative
  • Quantitative BCR-ABL1 Translocation Detection by RT-PCR for CML and ALL

Use

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), as well as e1a2 (minor breakpoint, p190). 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.

Limitations

In vitro studies have indicated that this assay has an analytical detection sensitivity of 4.5 log below the standard baseline. A negative result does not rule out the presence of low levels of BCR-ABL1 transcript below the level of detection of this assay, or the presence of rare BCR-ABL1 transcripts not detected by the assay.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).

Methodology

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.

Specimen Requirements

Specimen

Whole blood, bone marrow, or cell pellet

Volume

3 to 5 mL whole blood or 1 to 2 mL bone marrow

Minimum Volume

1 mL whole blood or bone marrow

Container

Lavender-top (EDTA) tube, green-top (sodium heparin) tube, or yellow-top (ACD-A) tube

Collection

Submit at room temperature. Specimens should arrive in the laboratory within 48 hours of collection. Indicate date and time of collection on test request form.

Storage Instructions

Submit at room temperature. If specimen has to be stored more than 48 hours, refrigerate at 2°C to 8°C.

Causes for Rejection

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

Clinical Information

Special Instructions

Please direct any questions regarding this test to oncology customer service at 800-345-4363.

References

Hughes T, Branford S. Molecular monitoring of chronic myeloid leukemia. Semin Hematol. 2003 Apr; 40(2 Suppl 2):62-68.12783378
NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia. Version 2.2017.
White HE, Matejtschuk P, Rigsby P, et al. Establishment of the first World Health Organization International Genetic Reference Panel for quantitation of BCR-ABL mRNA. Blood. 2010 Nov 25; 116(22):e111-117.20720184

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 481509 e13a2 (b2a2) transcript % 52130-2
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 481510 e14a2 (b3a2) transcript % 52131-0
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 481516 e1a2 transcript % 52132-8
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 480488 Interpretation: N/A
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 489031 Director Review 72486-4
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 481507 Background 77202-0
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 481508 Methodology 49549-9

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The LOINC® codes are copyright © 1994-2018, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf