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

The b2a2 (e13a2) and b3a2 (e14a2) fusion transcripts values are titrated to the current International Scale (IS). The standardized baseline is 100% BCR-ABLIS and the major molecular response (MMR) is 0.1% BCR-ABLIS. This test is used to quantify BCR-ABL1 transcript levels of the b2a2/b3a2 (p210) and e1a2 (p190) fusion transcripts. These BCR-ABL1 fusion transcripts are found in patients with CML and Philadelphia-positive ALL. This quantitative test is used to monitor the response of patients to imatinib mesylate or other therapies.

Limitations

In vitro studies have indicated that this assay has an analytical sensitivity that allows for the detection of approximately 1 cell containing the p190/p210 BCR-ABL1 fusion gene transcript in a background of 100,000 normal cells. 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.

Methodology

Reverse transcription polymerase chain reaction (RT-PCR)

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 more than 48 hours old; clotted blood

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
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 480482 b2a2 transcript % 52130-2
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 480487 b3a2 transcript % 52131-0
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 480502 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 480838 Background 77202-0
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 480839 Methodology 49549-9
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 000000 Serial Monitoring N/A
480481 BCR-ABL1, CML/ALL, PCR, Quant 52135-1 480841 BCR-ABL1, CML/ALL, PCR, Quant N/A

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The LOINC® codes are copyright © 1994-2017, 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