Collection Instructions

2 Lavender (EDTA) blood 
Specimens should be collected by blood draw of at least 8 mL into LAV (EDTA) tube(s) (with minimum of 10 million nucleated cells).

Collect

2 Lavender (EDTA) tubes, 8mL total 

Storage/Transport Temperature

Store whole blood specimen at 2-8°C
Deliver immediately on ice

Unacceptable Conditions

Specimens other than blood.
Specimens collected in anticoagulants other than EDTA
Severly hemolyzed or clotted specimens.
Frozen specimens
Blood specimens older than 48-72 hours may fail testing due to RNA degradation.

Test Barcode Number

22220

Lab Section

Molecular Diagnostic

Methodology

Multiplex real-time quantitative reverse transcription polymerase chain reaction (RT-qPCR) for the e13a2 (b2a2) and e14a2 (b3a2) transcripts, both of which encode a p210 protein

Commercial kit: FDA-cleared Asuragen QuantideX qPCR BCR-ABL IS kit

Performed

2x week

Reported

Expected TAT: 5 working days

Synonyms

  • BCR ABL Major

Performing Laboratory Website (click below)

UR Medicine Labs

Reference Interval

Reporting Structure: BCR-ABL1 transcript levels are reported as: 
                         1) %IS values: percent ratio of BCR-ABL1 to ABL1 expressed on the International Scale (IS)
                         2)  Molecular Reduction (MR) values; logarithmic decrease from the baseline of 100%IS or MR0

Table 1:  Relationship between %IS and MR values.

MR %IS
0.0 100
0.5 32
1.0 10
1.5 3.2
2.0 1
2.5 0.32
3.0 0.1
3.5 0.032
4.0 0.01
4.5 0.0032
4.7 0.002
5.0 0.001

Of note, the IS is a numeric scale anchored to the standardized baseline of 100%IS that was established by the International Randomized Study of Interferon and STI571 (IRIS) trial.  This baseline was derived from the median BCR-ABL1:BCR transcript levels of 30 CML patients at diagnosis (PMID: 14534335).  Log reductions (i.e. MR values) reflect the decrease in BCR-ABL1:ABL1 transcript levels from the IRIS study baseline of 100%IS, not the decrease from a given patient's pre-treatment level.

Interpretative considerations:  Only BCR-ABL1:ABL1 changes of 0.5 log or greater should be considered significant.

Reportable Range of Quantitation:  0.002%IS (MR4.7) - 50%IS (MR0.3)

Results cannot be accurately quantitated outside of the reportable range.  Results below or above these values will be reported as "Positive, below the lower limit of quantitation (LOQ) or "Positive, above the upper limit of quantitation (LOQ)," respectively.  Some patients with very low levels of BCR-ABL1 transcript (<0.002%IS, >MR4.7) may be reported as "Negative".  Therefore, a "Negative" result does not preclude the presence of low levels of leukemic cells in the patient.  This assay does not detect p190 or p230 transcripts.

Interpretive Data

CPT Codes

81206

LOINC Mapping

69380-4

Group Test Information

Result Test ID Reportable Result Test Name Result Type Type (Alpha or Numeric) Prompt Test
TYPM8 Y SPECIMEN TYPRE, MBCR I A  
CAS#4 Y PATH CASE #,MBCR I A  
MBCRR Y Mbcr/abl I A  
MBCIS Y %IS I A  
MBCQR Y Mbcrlabl QUANT I A  
INTMB Y INTERPRETATION,MBCR I A  
REVMB Y REVIEWED BY: I A  

CPT Codes

81206

LOINC Mapping

69380-4
Specimen Requirements

Collection Instructions

2 Lavender (EDTA) blood 
Specimens should be collected by blood draw of at least 8 mL into LAV (EDTA) tube(s) (with minimum of 10 million nucleated cells).

Collect

2 Lavender (EDTA) tubes, 8mL total 

Storage/Transport Temperature

Store whole blood specimen at 2-8°C
Deliver immediately on ice

Unacceptable Conditions

Specimens other than blood.
Specimens collected in anticoagulants other than EDTA
Severly hemolyzed or clotted specimens.
Frozen specimens
Blood specimens older than 48-72 hours may fail testing due to RNA degradation.

Test Barcode Number

22220

Testing

Lab Section

Molecular Diagnostic

Methodology

Multiplex real-time quantitative reverse transcription polymerase chain reaction (RT-qPCR) for the e13a2 (b2a2) and e14a2 (b3a2) transcripts, both of which encode a p210 protein

Commercial kit: FDA-cleared Asuragen QuantideX qPCR BCR-ABL IS kit

Performed

2x week

Reported

Expected TAT: 5 working days

Synonyms

  • BCR ABL Major

Performing Laboratory Website (click below)

UR Medicine Labs

Result Interpretation

Reference Interval

Reporting Structure: BCR-ABL1 transcript levels are reported as: 
                         1) %IS values: percent ratio of BCR-ABL1 to ABL1 expressed on the International Scale (IS)
                         2)  Molecular Reduction (MR) values; logarithmic decrease from the baseline of 100%IS or MR0

Table 1:  Relationship between %IS and MR values.

MR %IS
0.0 100
0.5 32
1.0 10
1.5 3.2
2.0 1
2.5 0.32
3.0 0.1
3.5 0.032
4.0 0.01
4.5 0.0032
4.7 0.002
5.0 0.001

Of note, the IS is a numeric scale anchored to the standardized baseline of 100%IS that was established by the International Randomized Study of Interferon and STI571 (IRIS) trial.  This baseline was derived from the median BCR-ABL1:BCR transcript levels of 30 CML patients at diagnosis (PMID: 14534335).  Log reductions (i.e. MR values) reflect the decrease in BCR-ABL1:ABL1 transcript levels from the IRIS study baseline of 100%IS, not the decrease from a given patient's pre-treatment level.

Interpretative considerations:  Only BCR-ABL1:ABL1 changes of 0.5 log or greater should be considered significant.

Reportable Range of Quantitation:  0.002%IS (MR4.7) - 50%IS (MR0.3)

Results cannot be accurately quantitated outside of the reportable range.  Results below or above these values will be reported as "Positive, below the lower limit of quantitation (LOQ) or "Positive, above the upper limit of quantitation (LOQ)," respectively.  Some patients with very low levels of BCR-ABL1 transcript (<0.002%IS, >MR4.7) may be reported as "Negative".  Therefore, a "Negative" result does not preclude the presence of low levels of leukemic cells in the patient.  This assay does not detect p190 or p230 transcripts.

Interpretive Data

Coding

CPT Codes

81206

LOINC Mapping

69380-4
URM Labs Internal
Test Build

Group Test Information

Result Test ID Reportable Result Test Name Result Type Type (Alpha or Numeric) Prompt Test
TYPM8 Y SPECIMEN TYPRE, MBCR I A  
CAS#4 Y PATH CASE #,MBCR I A  
MBCRR Y Mbcr/abl I A  
MBCIS Y %IS I A  
MBCQR Y Mbcrlabl QUANT I A  
INTMB Y INTERPRETATION,MBCR I A  
REVMB Y REVIEWED BY: I A  

CPT Codes

81206

LOINC Mapping

69380-4

Important Information

Lab Section

Molecular Diagnostic

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