3005839
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Diagnostic Qualitative BCR-ABL1 Assay with Reflex to p190 or p210 Quantitative Assays

DX BCR RFX
Example Reports
Not Detected
Positive Major

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Time Sensitive

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Informed Consent for Genetic Testing (Required for NY patients)

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Additional Technical Information

Ordering Recommendation

This qualitative screening test is appropriate for initial diagnosis of chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL). Use to detect the presence of p210 (major breakpoint), p190 (minor breakpoint), and p230 (micro breakpoint) fusions. If a common p210 or p190 BCR-ABL1 fusion transcript is detected, the appropriate test will be added to provide a quantitative value, which may be used as the diagnostic baseline to further monitor treatment response.

For patients with a known history of p210 or p190 fusion transcripts, refer to Quantitative Detection of BCR-ABL1, Major Form (p210) (3005840) or Quantitative Detection of BCR-ABL1, Minor Form (p190)​​​​​​​ (3016968). These two tests are the appropriate tests to monitor therapeutic response and to detect minimal residual disease (MRD). Low-level residual disease might not be detected by inappropriate use of this screening/diagnostic assay.

New York DOH Approval Status

This test is New York state 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, extracted DNA, CSF, FFPE tissue, ambient whole blood, or frozen whole blood or bone marrow.
Specimens collected in anticoagulants other than EDTA. Severely hemolyzed or clotted specimens.
Ambient bone marrow specimens past 7 days will be canceled.
Refrigerated whole blood or bone marrow specimens past 7 days will be canceled.

Remarks

This qualitative screening test is appropriate for initial diagnosis of chronic myeloid leukemia (CML) or acute lymphoblastic leukemia/lymphoma (ALL).

For patients with a known history of p210 or p190 fusion transcripts, refer to Quantitative Detection of BCR-ABL1, Major Form (p210) (ARUP test code 3005840) or Quantitative Detection of BCR-ABL1, Minor Form (p190) (ARUP test code 3016968).

Stability

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

Methodology

Reverse Transcription Polymerase Chain Reaction

Performed

Varies

Reported

4-10 days
If reflexed, TAT may be extended by 3-7 days.

Reference Interval

Interpretive Data

Refer to report.

Compliance Category

Laboratory Developed Test (LDT)

Note

This reflex assay is recommended when the BCR-ABL1 fusion form is not known or unclear. This reflex assay detects the presence of either the p210 (major breakpoint), p190 (minor breakpoint), or p230 (micro breakpoint). If the presence of either the common p210 or p190 BCR-ABL1 fusion is detected, then the appropriate quantitative test will be performed. Additional charges apply.

If the fusion form is known, refer to Quantitative Detection of BCR-ABL1, Major Form (p210) (ARUP test code 3005840) or Quantitative Detection of BCR-ABL1, Minor Form (p190) (ARUP test code 3016968).

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
02/21/2024
X
X
X
N/A

CPT Codes

81206; 81207; 81208; If reflexed, add 81206 or 81207

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Components

Component Test Code* Component Chart Name LOINC
3005851 Diagnostic Qual BCR-ABL1 Assay, Source 31208-2
3005852 Diagnostic Qual BCR-ABL1 Assay, Result 21821-4
* 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
  • CML qualitative RT-PCR
  • p210, p190 and p230
  • Philadelphia chromosome bone marrow/blood
  • t(9;22) by qualitative RT-PCR
Diagnostic Qualitative BCR-ABL1 Assay with Reflex to p190 or p210 Quantitative Assays