DiAGSure® BCR-ABL Fusion Detection Kit (Quantitative)

Catalog No.: GDQ2281-20R, GDQ2281-50R, GDQ-2281-100R
Intent to use:
The DiAGSure® BCR-ABL Fusion Detection Kit (Quantitative) is a real-time PCR assay designed for the accurate quantification of the BCR-ABL1 fusion gene, a key molecular hallmark in chronic myeloid leukemia (CML) and some cases of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In more than 95% of CML patients, the predominant transcript subtypes are e13a2 (b2a2), e14a2 (b3a2), or co-expression of both. This kit detects and quantifies these transcripts with high sensitivity and precision, facilitating diagnosis, monitoring of minimal residual disease (MRD), and assessment of treatment response. It is standardized against the 1st WHO International Genetic Reference Panel (NIBSC code: 09/138), with a detection range from 0.01% to 10% BCR-ABL1/ABL1 on the International Scale (IS). The assay supports effective clinical decisions, especially in patients receiving tyrosine kinase inhibitors, and integrates easily into major real-time PCR platforms.

Key Specifications:
 Quantifies BCR-ABL1 transcripts (e13a2/b2a2, e14a2/b3a2, or both) seen in over 95% of CML cases.
 Standardized to WHO reference panel (NIBSC: 09/138) for globally comparable results.
 Detection range: 0.01%–10% on IS, enabling deep molecular response and MRD monitoring.
 High sensitivity and specificity ensure accurate tracking of leukemic burden and treatment response.
 CE-IVD and CDSCO approved, meeting global and national diagnostic standards.
 Compatible with major qPCR platforms for easy lab integration.

Sample types:
Whole Blood, Biopsy tissue, FNAC.

Product information: