Ordering Recommendations

  1. Indications for testing include diagnosis, prognosis, and therapeutic monitoring in patients with confirmed BCRABL p210+ leukemia.
  2. This test does not detect the rare BCR-ABL1 micro (p230) fusion form.
  3. For the p190 fusion form (minor breakpoint), order BCR-ABL1, p190, Quantitative.

Performed

Monday - Friday

Methodology

Reverse Transcription / Quantitative Polymerase Chain Reaction

Reported

Routine: 5 - 7 days

Synonyms

  • BCR-ABL1, Major (p210), Quantitative
  • BCR-ABL1 Major p210, Bone Marrow
  • Bone Marrow, BCR-ABL1 Major p210
  • Chronic Myelogenous Leukemia (CML)
  • Acute Lymphoblastic Leukemia (ALL)
  • BCR-ABL 1
  • BCR/ABL
  • Major Breakpoint
  • Fusion Transcript
  • BCRABL Fusion Gene
  • Philadelphia Chromosome
  • Myeloproliferative Disorders
  • t(9;22)
  • Reciprocol Translocation
  • BCRABL p210+ Leukemia
  • Tyrosine Kinase Inhibitor (TKI) Therapy Monitoring
  • Chronic Myelogenous Leukemia Monitoring
  • CML Monitoring
  • Clinical Genomics

Performing Lab

Clinical Genomics

Turnaround Time

7 days

Add-on Eligibility

Yes, within 48 hours of collection
*If RNA has been extracted previously for other Clinical Genomics tests, this is stored for 6 weeks and may qualify for add-on

Specimen Type

Bone Marrow

Specimen Volume

3 mL (Minimum: 1 mL)

Collection Container

3.0 mL EDTA Whole Blood Tube (Lavender Top Vacutainer)

Unacceptable Conditions

  1. Severely clotted or grossly hemolyzed specimens
  2. Specimens that have been improperly collected, stored, or transported
  • Specimens collected in preservatives other than EDTA
    • ACD tubes are accepted, but EDTA is preferred
    • Heparinized specimens are accepted, but not recommended
  • Serum or plasma
  • Specimens that have been frozen
  • Commingled specimens
  1. Specimens in tubes that have been damaged or broken during transport
  2. Specimens with insufficient volume for testing
  3. Unlabeled or mislabeled specimens

Storage/Transport Temperature

Transport Instructions      
Collection Location Transport Temperature Processing Required Timeframe
ED/Inpatient Room Temperature None Specimen must be received by the lab within 1 hour of collection
Refrigerated (Ice Packs) None Specimen must be received by the lab within 48 hours of collection
Laboratory/Outpatient/Off-Site Room Temperature None Specimen must be received by the lab within 1 hour of collection
Refrigerated (Ice Packs) None Specimen must be received by the lab within 48 hours of collection

Storage: Refrigerated

Stability (from collection to initiation)

Stability:
Prior to Extraction:
  • Room Temperature: 1 hour
  • Refrigerated: 48 hours
  • Frozen: Unacceptable
Extracted RNA:
  • Room Temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: Indefinitely

Laboratory Storage: 
  • Original Specimen: Refrigerated
  • Extracted RNA: Frozen
Laboratory Retention: 
  • Original Specimen: 1 month
  • Extracted RNA: 6 weeks

Collection Instructions

Labelling Instructions:
When labeling blood tubes, leave a small window visible for the lab to assess the fill volume and sample integrity. Ensure that the barcode is in the correct orientation.


Collection Instructions:
Follow the correct order of draw when collecting with additional orders and tube types:
     

Reference Interval

Not Detected: Negative for BCR-ABL1 p210 fusion transcripts

Interpretive Data

This test is used for the detection of BCR-ABL1 mRNA fusion transcripts that result from translocation-mediated fusions between BCR exon 13 or 14 and ABL1 exon 2. The assay quantifies BCR-ABL1 transcript levels for initial diagnosis and ongoing therapeutic monitoring. BCR-ABL1 fusion transcripts are identified by real-time quantitative PCR (RT-qPCR) using primers designed to detect the major (p210) BCR breakpoints at e13a2 and e14a2. A normalized copy number (NCN) is calculated from the ratio of BCR-ABL1 molecules to ABL1 molecules. The NCN is converted to a value on the international scale (IS) with a validated reference sample. An IS value of 100% corresponds to the standardized baseline value at diagnosis as determined by the original IRIS trial of imatinib therapy in chronic phase CML patients. A three log reduction from the baseline value (0.1% IS) constitutes a major molecular response (MMR) to tyrosine kinase inhibitor (TKI) therapy.

This test is capable of detecting BCR-ABL1 transcript levels below 0.01% IS or 10-fold below MMR. The results of this test must be interpreted using morphologic and other clinically relevant data. These results should not be used alone for a diagnosis of malignancy.
 
BCRABL Quantitative, p210 Interpretation
Qualitative Result Quantitation Interpretation
Not Detected 0.00000 BCR-ABL1 p210 transcripts were not detected. A major molecular response (MMR) is defined as a 3-log or greater reduction in transcript levels relative to a standardized baseline value.
Detected < Value Positive for BCR-ABL1 p210 fusion transcripts, below the level of quantification.

BCR-ABL1 p210 fusion transcripts were detected in 2 of 2 replicate analyses. However, accurate quantitation is not possible as the number of BCR-ABL1 molecules detected is below the linear range of the assay. A major molecular response (MMR) is defined as a 3-log or greater reduction in transcript levels relative to a standardized baseline value.
Detected Value BCR-ABL1 p210 transcripts were detected. A major molecular response (MMR) is defined as a 3-log or greater reduction in transcript levels relative to a standardized baseline value.
Ordering

Ordering Recommendations

  1. Indications for testing include diagnosis, prognosis, and therapeutic monitoring in patients with confirmed BCRABL p210+ leukemia.
  2. This test does not detect the rare BCR-ABL1 micro (p230) fusion form.
  3. For the p190 fusion form (minor breakpoint), order BCR-ABL1, p190, Quantitative.

Performed

Monday - Friday

Methodology

Reverse Transcription / Quantitative Polymerase Chain Reaction

Reported

Routine: 5 - 7 days

Synonyms

  • BCR-ABL1, Major (p210), Quantitative
  • BCR-ABL1 Major p210, Bone Marrow
  • Bone Marrow, BCR-ABL1 Major p210
  • Chronic Myelogenous Leukemia (CML)
  • Acute Lymphoblastic Leukemia (ALL)
  • BCR-ABL 1
  • BCR/ABL
  • Major Breakpoint
  • Fusion Transcript
  • BCRABL Fusion Gene
  • Philadelphia Chromosome
  • Myeloproliferative Disorders
  • t(9;22)
  • Reciprocol Translocation
  • BCRABL p210+ Leukemia
  • Tyrosine Kinase Inhibitor (TKI) Therapy Monitoring
  • Chronic Myelogenous Leukemia Monitoring
  • CML Monitoring
  • Clinical Genomics

Performing Lab

Clinical Genomics

Turnaround Time

7 days

Add-on Eligibility

Yes, within 48 hours of collection
*If RNA has been extracted previously for other Clinical Genomics tests, this is stored for 6 weeks and may qualify for add-on
Collection

Specimen Type

Bone Marrow

Specimen Volume

3 mL (Minimum: 1 mL)

Collection Container

3.0 mL EDTA Whole Blood Tube (Lavender Top Vacutainer)

Unacceptable Conditions

  1. Severely clotted or grossly hemolyzed specimens
  2. Specimens that have been improperly collected, stored, or transported
  • Specimens collected in preservatives other than EDTA
    • ACD tubes are accepted, but EDTA is preferred
    • Heparinized specimens are accepted, but not recommended
  • Serum or plasma
  • Specimens that have been frozen
  • Commingled specimens
  1. Specimens in tubes that have been damaged or broken during transport
  2. Specimens with insufficient volume for testing
  3. Unlabeled or mislabeled specimens

Storage/Transport Temperature

Transport Instructions      
Collection Location Transport Temperature Processing Required Timeframe
ED/Inpatient Room Temperature None Specimen must be received by the lab within 1 hour of collection
Refrigerated (Ice Packs) None Specimen must be received by the lab within 48 hours of collection
Laboratory/Outpatient/Off-Site Room Temperature None Specimen must be received by the lab within 1 hour of collection
Refrigerated (Ice Packs) None Specimen must be received by the lab within 48 hours of collection

Storage: Refrigerated

Stability (from collection to initiation)

Stability:
Prior to Extraction:
  • Room Temperature: 1 hour
  • Refrigerated: 48 hours
  • Frozen: Unacceptable
Extracted RNA:
  • Room Temperature: Unacceptable
  • Refrigerated: Unacceptable
  • Frozen: Indefinitely

Laboratory Storage: 
  • Original Specimen: Refrigerated
  • Extracted RNA: Frozen
Laboratory Retention: 
  • Original Specimen: 1 month
  • Extracted RNA: 6 weeks

Collection Instructions

Labelling Instructions:
When labeling blood tubes, leave a small window visible for the lab to assess the fill volume and sample integrity. Ensure that the barcode is in the correct orientation.


Collection Instructions:
Follow the correct order of draw when collecting with additional orders and tube types:
     
Result Interpretation

Reference Interval

Not Detected: Negative for BCR-ABL1 p210 fusion transcripts

Interpretive Data

This test is used for the detection of BCR-ABL1 mRNA fusion transcripts that result from translocation-mediated fusions between BCR exon 13 or 14 and ABL1 exon 2. The assay quantifies BCR-ABL1 transcript levels for initial diagnosis and ongoing therapeutic monitoring. BCR-ABL1 fusion transcripts are identified by real-time quantitative PCR (RT-qPCR) using primers designed to detect the major (p210) BCR breakpoints at e13a2 and e14a2. A normalized copy number (NCN) is calculated from the ratio of BCR-ABL1 molecules to ABL1 molecules. The NCN is converted to a value on the international scale (IS) with a validated reference sample. An IS value of 100% corresponds to the standardized baseline value at diagnosis as determined by the original IRIS trial of imatinib therapy in chronic phase CML patients. A three log reduction from the baseline value (0.1% IS) constitutes a major molecular response (MMR) to tyrosine kinase inhibitor (TKI) therapy.

This test is capable of detecting BCR-ABL1 transcript levels below 0.01% IS or 10-fold below MMR. The results of this test must be interpreted using morphologic and other clinically relevant data. These results should not be used alone for a diagnosis of malignancy.
 
BCRABL Quantitative, p210 Interpretation
Qualitative Result Quantitation Interpretation
Not Detected 0.00000 BCR-ABL1 p210 transcripts were not detected. A major molecular response (MMR) is defined as a 3-log or greater reduction in transcript levels relative to a standardized baseline value.
Detected < Value Positive for BCR-ABL1 p210 fusion transcripts, below the level of quantification.

BCR-ABL1 p210 fusion transcripts were detected in 2 of 2 replicate analyses. However, accurate quantitation is not possible as the number of BCR-ABL1 molecules detected is below the linear range of the assay. A major molecular response (MMR) is defined as a 3-log or greater reduction in transcript levels relative to a standardized baseline value.
Detected Value BCR-ABL1 p210 transcripts were detected. A major molecular response (MMR) is defined as a 3-log or greater reduction in transcript levels relative to a standardized baseline value.

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