Ordering Recommendations

  1. Indications for testing include diagnosis, prognosis, and therapeutic monitoring in patients with confirmed BCRABL p190+ leukemia.
  2. For p210 fusion form (major breakpoint), order BCR-ABL1, p210, Quantitative.

Performed

Monday - Friday

Methodology

Reverse Transcription / Quantitative Polymerase Chain Reaction

Reported

Routine: 5 - 7 days

Synonyms

  • BCR-ABL1, Minor (p190), Quantitative
  • BCR-ABL1 Minor p190, Bone Marrow
  • Bone Marrow, BCR-ABL1 Minor p190
  • Acute Lymphoblastic Leukemia (ALL)
  • BCR-ABL1
  • BCR/ABL
  • Minor Breakpoint
  • Fusion Transcript
  • BCRABL Fusion Gene
  • Philadelphia Chromosome
  • Myeloproliferative Disorders
  • t(9;22)
  • Reciprocol Translocation
  • BCRABL p190+ Leukemia
  • Tyrosine Kinase Inhibitor (TKI) Therapy Monitoring
  • Acute Lymphoblastic Leukemia Monitoring
  • ALL 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 p190 fusion transcripts

Interpretive Data

This test is used for the detection of BCR-ABL1 mRNA fusion transcripts that result from translocations between BCR exon 1 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 minor (p190) BCR breakpoint at e1a2. A normalized copy number (NCN) is calculated from the ratio of BCR-ABL1 molecules to ABL1 molecules. A three log reduction from a baseline value constitutes a major molecular response (MMR) to tyrosine kinase inhibitor (TKI) therapy.

The limit of detection of this test is 10 molecules of BCR-ABL1 fusion transcripts which represents the low end of the linear range. The results of this test must be interpreted using morphologic and other clinically relevant data. These results should not be used alone for diagnosis of malignancy.
 
BCRABL Quantitative, p190 Interpretation
Qualitative Result Quantitation Interpretation
Not Detected 0.00000 BCR-ABL1 p190 transcripts were not detected
Detected < Value Positive for BCR-ABL1 p190 fusion transcripts, below the level of quantification.

BCR-ABL1 p190 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. Continued monitoring with repeat testing when clinically indicated is recommended.
Detected Value BCR-ABL1 p190 transcripts were detected
Ordering

Ordering Recommendations

  1. Indications for testing include diagnosis, prognosis, and therapeutic monitoring in patients with confirmed BCRABL p190+ leukemia.
  2. For p210 fusion form (major breakpoint), order BCR-ABL1, p210, Quantitative.

Performed

Monday - Friday

Methodology

Reverse Transcription / Quantitative Polymerase Chain Reaction

Reported

Routine: 5 - 7 days

Synonyms

  • BCR-ABL1, Minor (p190), Quantitative
  • BCR-ABL1 Minor p190, Bone Marrow
  • Bone Marrow, BCR-ABL1 Minor p190
  • Acute Lymphoblastic Leukemia (ALL)
  • BCR-ABL1
  • BCR/ABL
  • Minor Breakpoint
  • Fusion Transcript
  • BCRABL Fusion Gene
  • Philadelphia Chromosome
  • Myeloproliferative Disorders
  • t(9;22)
  • Reciprocol Translocation
  • BCRABL p190+ Leukemia
  • Tyrosine Kinase Inhibitor (TKI) Therapy Monitoring
  • Acute Lymphoblastic Leukemia Monitoring
  • ALL 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 p190 fusion transcripts

Interpretive Data

This test is used for the detection of BCR-ABL1 mRNA fusion transcripts that result from translocations between BCR exon 1 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 minor (p190) BCR breakpoint at e1a2. A normalized copy number (NCN) is calculated from the ratio of BCR-ABL1 molecules to ABL1 molecules. A three log reduction from a baseline value constitutes a major molecular response (MMR) to tyrosine kinase inhibitor (TKI) therapy.

The limit of detection of this test is 10 molecules of BCR-ABL1 fusion transcripts which represents the low end of the linear range. The results of this test must be interpreted using morphologic and other clinically relevant data. These results should not be used alone for diagnosis of malignancy.
 
BCRABL Quantitative, p190 Interpretation
Qualitative Result Quantitation Interpretation
Not Detected 0.00000 BCR-ABL1 p190 transcripts were not detected
Detected < Value Positive for BCR-ABL1 p190 fusion transcripts, below the level of quantification.

BCR-ABL1 p190 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. Continued monitoring with repeat testing when clinically indicated is recommended.
Detected Value BCR-ABL1 p190 transcripts were detected

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