Ordering Recommendation

This quantitative test is appropriate for therapeutic monitoring of BCR-ABL1 major (p210) positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL). This test is designed to meet the current National Comprehensive Cancer Network (NCCN) guidelines and is recommended for detection of minimal residual disease (MRD). 

For patients with uncertain diagnoses or unknown forms of BCR-ABL1 fusion transcripts, consider ordering Diagnostic Qualitative BCR-ABL1 Assay with Reflex to p190 or p210 Quantitative Assays (3005839).

Mnemonic

QNT BCRMAJ

Methodology

Reverse Transcription Polymerase Chain Reaction

Performed

RNA isolation: Sun-Sat
Assay:
Varies

Reported

5-9 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation
Collect

Whole blood or bone marrow in lavender (EDTA).

Specimen Preparation

Whole blood: Transport 5 mL whole blood. (Min: 3 mL)
Bone marrow:
Transport 3 mL bone marrow. (Min: 1 mL)
Refrigerate immediately. Specimens must be received within 48 hours of collection due to lability of RNA.

Storage/Transport Temperature

Whole blood and bone marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.

Unacceptable Conditions

Serum, plasma, ambient or frozen bone marrow or whole blood, CSF, or FFPE tissue. Specimens collected in anticoagulants other than EDTA. Severely hemolyzed or clotted specimens.
Ambient whole blood and ambient bone marrow specimens past 7 days will be canceled. Refrigerated whole blood or bone marrow past 7 days will be canceled.

Remarks

This quantitative test is recommended for therapeutic monitoring and detection of minimal residual disease for patients with an established diagnosis. For patients with uncertain diagnoses or unknown forms of BCR-ABL1 fusion transcripts, please order 3005839 Diagnostic Qualitative BCR-ABL1 Assay with Reflex to p190 or p210 Quantitative Assays.

Stability

Ambient: Unacceptable; Refrigerated: 48 hours; Frozen: Unacceptable

Reference Interval

Interpretive Data

Refer to report.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the U.S. Food and Drug Administration. This test was performed in a CLIA-certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

This test does not detect the BCR-ABL1 micro (p230) or minor (p190) fusion transcripts. This test does not detect rare BCR-ABL1 major (p210) forms involving beyond ABL1 exon 2.

For the p190 fusion form (minor breakpoint), order BCR-ABL1, Minor (p190), Quantitative (ARUP test code 2005016).

Hotline History

N/A

CPT Codes

81206

Components

Component Test Code* Component Chart Name LOINC
3005854 Quant BCR-ABL1, Major (p210), Source 31208-2
3005855 Quant BCR-ABL1, Major (p210), Result 42714-6
3005856 Quant BCR-ABL1, Major (p210), IS Percent 69380-4
3005858 Quant BCR-ABL1, Major (p210), EER 11526-1
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • BCR::ABL1
  • p210
  • Philadelphia chromosome Ph major, bone marrow/blood
  • Quantitative RT-PCR, CML or ALL
  • t(9;22) major by quantitative RT-PCR
Quantitative Detection of BCR-ABL1, Major Form (p210)