Major and Minor BCR-ABL Mutation Quantification Kit

Chronic myeloid leukaemia (CML) and acute lymphoblastic leukemia (ALL) are characterized by the generation of Philadelphia (Ph) chromosome which arises from translocation between chromosomes 9 (region q34: ABL) and 22 (region q11: BCR). This translocation results in the formation of BCR-ABL fusion gene whereby majority of the breakpoints occurs in two regions; after the 13th exon resulting in a b2a2 (e13a2) fusion or after the 14th exon resulting in a b3a2 (e14a2) fusion. These fusions are mostly detected in CML patients and are translated into the constitutively active tyrosine kinase of 210kDa (P210). In Ph-positive ALL patients, the breakpoint typically occurs in the region after the 1st exon, resulting in the formation e1a2 fusion. This e1a2 fusion mRNAs are translated into the P190 constitutively active tyrosine kinase. Molecular detection and quantification of the BCR-ABL fusions are essential for disease diagnosis, monitoring of therapeutic responses and minimal residual disease detection.
The Clarity™ Major BCR-ABL Mutation Quantitation Kit and Clarity™ Minor BCR-ABL Mutation Quantitation Kit provide reagents optimized for the quantitative detection of b2a2 and/or b3a2 mutant cDNA* and e1a2 mutant cDNA* respectively in human whole blood samples using the Clarity™ digital PCR instrument.



Precise quantification of b2a2, b3a2 or e1a2 mutation abundance

Ease of Use

Low hands-on-time, compatible with most conventional thermal cyclers

High Sensitivity

Detect as low as 0.01% of b2a2, b3a2 or e1a2  mutant DNA

Manufactured in Singapore under ISO 13485

High Throughput Analysis

Analyze up to 96 reactions in 4 hours

Product Performance


The Clarity™ Major BCR-ABL and Minor BCR-ABL Mutation Quantification Kit detected at least 0.01% mutant cDNA against a high background of more than 35,000 copies of total ABL cDNA. In addition, excellent linearity is achieved (R2 >0.999) from 100% down to 0.01% for the respective mutant fractions (Figures 1 & 2).


TechnologyDigital PCR
Target Sequenceb2a2, b3a2 or e1a2 and ABL cDNA
Sensitivity (LOD)0.01% mutation
Time to Result< 4 h
Specimen TypeWhole Blood
Reporting FormatRatio of mutant (b2a2, b3a2 or e1a2) versus total ABL expression
Instrument TestedClarity™ digital PCR system (Cat. No. 10001)
Additional Material RequiredClarity™ consumables package (Cat. No. 10011)
Detection ChannelsFAM (b2a2, b3a2 or e1a2 cDNA), HEX (ABL cDNA)
Kit Storage-20°C, avoid repeated freezing and thawing of kit contents

Ordering Information

Product nameDescriptionCat. No.
Clarity™ EGFR T790M Mutation Quantification Kit48 reactions10016
Clarity™ Epstein-Barr Virus Quantification Kit96 reactions10017
Clarity™ Hepatitis B Virus Quantification Kit96 reactions10018
Clarity™ EGFR L858R Mutation Quantification Kit48 reactions10019
Clarity™ IDH2 Mutation Quantification Kit48 reactions10021
Clarity™ Major BCR-ABL Mutation Quantification Kit96 reactions10022
Clarity™ Minor BCR-ABL Mutation Quantification Kit96 reactions10023