Test Name

BCR-ABL1 Follow-Up Quantitative Assay for Minimal Residual Disease Monitoring (Blood only)

Test Number

LAB9001 (Blood)

Orderable Test Codes

CPT81206 – BCR-ABL1 Major (p210)
CPT81207 – BCR-ABL1 Minor (p190)

Synonyms

  • BCR-ABL
  • BCR-ABL1 Reciprocal Translocation
  • e13a2 and e14a2 Fusion Transcripts
  • e1a2 Fusion Transcripts
  • Major (p210) Breakpoint
  • Minor (p190) Breakpoint
  • Philadelphia Chromosome t(9:22)

Test Includes

BCR-ABL1 Major (p210)Relative quantitation of fusion transcripts resulting from t(9;22)(q34;q11.2) translocation with major (p210) BCR-ABL1 breakpoint. Note: This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the minor (p190) and the micro (p230) breakpoints.
BCR-ABL1 Minor (p190)Relative quantitation of fusion transcripts resulting from t(9;22)(q34;q11.2) translocation with minor (p190) BCR-ABL1 breakpoint. Note: This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the major (p210) and the micro (p230) breakpoints.

 

Performing Laboratory / Facility

UCLA Molecular Diagnostics Laboratories (MDL)

Performing Section

Molecular Pathology

Availability

Monday through Friday, 0700-1700

Turnaround Time

10 days from receipt of specimen in performing lab.

Methodology

BCR-ABL1 Major (p210)The QuantideX® qPCR BCR-ABL Major Kit is an in vitro nucleic acid amplification test for the relative quantitation of BCR-ABL1 major and endogenous ABL1 transcripts in total RNA. It is a multiplex reverse transcription-quantitative RT-PCR hydrolysis probe technology performed on the Applied Biosystems 7500 Fast Dx Instrument.
BCR-ABL1 Minor (p190)The QuantideX® qPCR BCR-ABL1 Minor Kit is an in vitro nucleic acid amplification test for the relative quantitation of BCR-ABL1 minor and endogenous ABL1 transcripts in total RNA. It is a multiplex reverse transcription-quantitative RT-PCR hydrolysis probe technology performed on the Applied Biosystems 7500 Fast Dx Instrument.

 

Use

BCR-ABL1 Major (p210)This test can be used to monitor response to therapy for disorders including chronic myeloid leukemia (CML) and B-lymphoblastic leukemia (B-ALL) in which a t(9:22)(q34q11.2) reciprocal translocation with a major (p210) BCR-ABL1 breakpoint can be found.
BCR-ABL1 Minor (p190)This test can be used to monitor response to therapy for disorders including chronic myeloid leukemia (CML) and B-lymphoblastic leukemia (B-ALL) in which a t(9:22)(q34q11.2) reciprocal translocation with a minor (p190) BCR-ABL1 breakpoint can be found.

 

Applies To

B-lymphoblastic Leukemia (B-ALL)
Chronic Myeloid Leukemia (CML)

Limitations

The amount of RNA extracted may not be sufficient to perform the assay when the white blood count of the patient is very low. RNA is very labile; significant degradation during collection or transport may result in assay failure.
BCR-ABL1 Major (p210)This test is only designed to detect e13a2 and e14a2 fusion transcripts resulting from a major (p210) BCR-ABL1 breakpoint. This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the minor (p190) and the micro (p230) breakpoints.
BCR-ABL1 Minor (p190)This test is only designed to detect e13a2 and e14a2 fusion transcripts resulting from a minor (p190) BCR-ABL1 breakpoint. This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the major (p210) and the micro (p230) breakpoints.

 

Specimen Type

Whole Blood

Container

Lavender/EDTA

Collection Instructions

Shared tubes, such as CBC tubes, are not acceptable specimens due to risk of cross-contamination. Send whole blood to the Laboratory at ambient temperature or refrigerated. Do not freeze.

Volume

8 mL

Minimum Volume

4 mL

Shipping and Handling Instructions

Transport specimen at room temperature or refrigerated at 2°C to 8°C.

Causes for Rejection

Shared tubes, such as CBC tubes; clotted specimen; improperly labelled specimen; broken specimen tube; specimen older than 96 hours.

Reference Range

BCR-ABL1 Major (p210)No major (p210) BCR-ABL1 fusion transcript detected.
BCR-ABL1 Minor (p190)No minor (p190) BCR-ABL1 fusion transcript detected.

 

Interpretive Data

BCR-ABL1 Major (p210)If detected, a ratio of the major (p210) BCR-ABL1 fusion transcript level to the endogenous ABL1 transcript level is reported on an international scale (IS) along with a molecular reduction (MR) value.
BCR-ABL1 Minor (p190)If detected, a ratio of the minor (p190) BCR-ABL1 fusion transcript level to the endogenous ABL1 transcript level is reported on %ratio.

 

Test Information

Test Name

BCR-ABL1 Follow-Up Quantitative Assay for Minimal Residual Disease Monitoring (Blood only)

Test Number

LAB9001 (Blood)

Orderable Test Codes

CPT81206 – BCR-ABL1 Major (p210)
CPT81207 – BCR-ABL1 Minor (p190)

Synonyms

  • BCR-ABL
  • BCR-ABL1 Reciprocal Translocation
  • e13a2 and e14a2 Fusion Transcripts
  • e1a2 Fusion Transcripts
  • Major (p210) Breakpoint
  • Minor (p190) Breakpoint
  • Philadelphia Chromosome t(9:22)

Test Includes

BCR-ABL1 Major (p210)Relative quantitation of fusion transcripts resulting from t(9;22)(q34;q11.2) translocation with major (p210) BCR-ABL1 breakpoint. Note: This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the minor (p190) and the micro (p230) breakpoints.
BCR-ABL1 Minor (p190)Relative quantitation of fusion transcripts resulting from t(9;22)(q34;q11.2) translocation with minor (p190) BCR-ABL1 breakpoint. Note: This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the major (p210) and the micro (p230) breakpoints.

 

Performing Laboratory / Facility

UCLA Molecular Diagnostics Laboratories (MDL)

Performing Section

Molecular Pathology

Availability

Monday through Friday, 0700-1700

Turnaround Time

10 days from receipt of specimen in performing lab.

Methodology

BCR-ABL1 Major (p210)The QuantideX® qPCR BCR-ABL Major Kit is an in vitro nucleic acid amplification test for the relative quantitation of BCR-ABL1 major and endogenous ABL1 transcripts in total RNA. It is a multiplex reverse transcription-quantitative RT-PCR hydrolysis probe technology performed on the Applied Biosystems 7500 Fast Dx Instrument.
BCR-ABL1 Minor (p190)The QuantideX® qPCR BCR-ABL1 Minor Kit is an in vitro nucleic acid amplification test for the relative quantitation of BCR-ABL1 minor and endogenous ABL1 transcripts in total RNA. It is a multiplex reverse transcription-quantitative RT-PCR hydrolysis probe technology performed on the Applied Biosystems 7500 Fast Dx Instrument.

 

Use

BCR-ABL1 Major (p210)This test can be used to monitor response to therapy for disorders including chronic myeloid leukemia (CML) and B-lymphoblastic leukemia (B-ALL) in which a t(9:22)(q34q11.2) reciprocal translocation with a major (p210) BCR-ABL1 breakpoint can be found.
BCR-ABL1 Minor (p190)This test can be used to monitor response to therapy for disorders including chronic myeloid leukemia (CML) and B-lymphoblastic leukemia (B-ALL) in which a t(9:22)(q34q11.2) reciprocal translocation with a minor (p190) BCR-ABL1 breakpoint can be found.

 

Applies To

B-lymphoblastic Leukemia (B-ALL)
Chronic Myeloid Leukemia (CML)

Limitations

The amount of RNA extracted may not be sufficient to perform the assay when the white blood count of the patient is very low. RNA is very labile; significant degradation during collection or transport may result in assay failure.
BCR-ABL1 Major (p210)This test is only designed to detect e13a2 and e14a2 fusion transcripts resulting from a major (p210) BCR-ABL1 breakpoint. This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the minor (p190) and the micro (p230) breakpoints.
BCR-ABL1 Minor (p190)This test is only designed to detect e13a2 and e14a2 fusion transcripts resulting from a minor (p190) BCR-ABL1 breakpoint. This test is not designed to detect fusion transcripts resulting from other BCR-ABL1 breakpoints such as the major (p210) and the micro (p230) breakpoints.

 

Specimen Collection and Handling

Specimen Type

Whole Blood

Container

Lavender/EDTA

Collection Instructions

Shared tubes, such as CBC tubes, are not acceptable specimens due to risk of cross-contamination. Send whole blood to the Laboratory at ambient temperature or refrigerated. Do not freeze.

Volume

8 mL

Minimum Volume

4 mL

Shipping and Handling Instructions

Transport specimen at room temperature or refrigerated at 2°C to 8°C.

Causes for Rejection

Shared tubes, such as CBC tubes; clotted specimen; improperly labelled specimen; broken specimen tube; specimen older than 96 hours.
Result Interpretation

Reference Range

BCR-ABL1 Major (p210)No major (p210) BCR-ABL1 fusion transcript detected.
BCR-ABL1 Minor (p190)No minor (p190) BCR-ABL1 fusion transcript detected.

 

Interpretive Data

BCR-ABL1 Major (p210)If detected, a ratio of the major (p210) BCR-ABL1 fusion transcript level to the endogenous ABL1 transcript level is reported on an international scale (IS) along with a molecular reduction (MR) value.
BCR-ABL1 Minor (p190)If detected, a ratio of the minor (p190) BCR-ABL1 fusion transcript level to the endogenous ABL1 transcript level is reported on %ratio.

 

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