BCR-ABL1, Qualitative with Reflex to BCR-ABL1 Quantitative

2005010
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Example Reports
Detected
Not Detected
Positive Micro

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Time Sensitive

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Additional Technical Information
Ordering Recommendation

For use in detecting the presence of a BCR-ABL1 fusion, for determining breakpoint status, and for baseline quantitation.

Mnemonic
BCR RFLX
Methodology

Reverse Transcription Polymerase Chain Reaction

Performed

RNA isolation: Sun-Sat
Assay: Sun-Sat

Reported

4-8 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA) or bone marrow (EDTA). Also acceptable: RNA extracted by CLIA certified lab.

Specimen Preparation

Whole Blood: Transport 5 mL whole blood. (Min: 4 mL)
Bone Marrow: Transport 3 mL bone marrow. (Min: 1 mL)
Specimens must be received within 48 hours of collection due to lability of RNA.
Extracted RNA: Transport 40 uL RNA with at least 40 ng/uL concentration. (Min: 40 uL) Transport RNA in a tissue transport kit (ARUP Supply #47808) available online through eSupply using ARUP Connect™ or contact ARUP Client Services at (800) 522-2787.

Storage/Transport Temperature

Whole Blood or Bone Marrow: CRITICAL REFRIGERATED. Separate specimens must be submitted when multiple tests are ordered.
Extracted RNA: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered.

Unacceptable Conditions

Serum, plasma, CSF, extracted DNA, RNA extracted by a non-CLIA lab, bone core, or FFPE tissue. Specimens collected in anticoagulants other than indicated. Severely hemolyzed or clotted specimens.

Remarks
Stability

Ambient: 1 hour; Refrigerated: 48 hours; Frozen: Unacceptable
Extracted RNA: Ambient: Unacceptable; Refrigerate: Unacceptable; Frozen: Indefinitely

Reference Interval
Interpretive Data

Refer to report.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

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 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 BCR-ABL1, Major (p210), Quantitative (ARUP test code 2005017) or BCR-ABL1, Minor (p190), Quantitative (ARUP test code 2005016).

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
07/07/2020
X
02/18/2020
X
X
X
X
08/19/2019
X
05/20/2019
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
0055553 BCR-ABL1, t(9;22) Qual by RT-PCR 21821-4
2006592 BCR-ABL1 Source 31208-2
* 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
  • p190
  • p210
  • p230
  • PH1
  • philadelphia chromosome
  • Philadelphia MS
  • t(9;22)
BCR-ABL1, Qualitative with Reflex to BCR-ABL1 Quantitative