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Oncology & Haematology · NPM1
Healthincode Distributed by Goffin Diagnostics

CBFB-MYH11 Kit

The Unmatched Potential of the CBFB-MYH11 Kit This advanced diagnostic kit identifies and quantifies the CBFB-MYH11 fusion gene, a critical marker in Acute Myeloid Leukemia (AML), through real-time PCR technology. With its capability to calculate the number of copies of both the rearrangement and the endogenous gene ABL1, it offers a nuanced understanding of the disease. Additionally, the kit supports minimal residual disease (MRD) detection, making it a cornerstone tool for professionals in molecular biology research.

Real-Time PCR RUO Healthincode 1 Package (48x2 Reactions)
Technique
Real-Time PCR
Brand
Healthincode
Packaging
1 Package (48x2 Reactions)
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Product details

This kit in detail

  • Real-Time PCR
  • Sensitivity to MR4: 0.01%
  • ABL1 Copy Calculation
  • MRD Capability
  •  

Introducing CBFB-MYH11 Kit

The CBFB-MYH11 Kit is an advanced molecular diagnostic platform designed to facilitate the precise identification and quantification of the CBFB-MYH11 fusion gene, resultant from chromosomal rearrangement inv(16)(p13q22). This genetic aberration is pivotal in the diagnosis and prognosis of Acute Myeloid Leukemia (AML), and the kit aims to provide clinicians and molecular biologists with a robust, reliable method for its detection.

Utilizing sophisticated real-time Polymerase Chain Reaction (PCR) technology, the kit employs a combination of oligonucleotides and hydrolysis probes. It is tailored to amplify and quantify the type A variant of the CBFB-MYH11 fusion gene, accounting for 85% of such occurrences. The kit uses a reference plasmid for calculating the number of copies of the rearrangement and the endogenous gene ABL1, thereby providing a comprehensive analytical output.

Adherence to stringent quality standards ensures that each component of the kit performs optimally. The Limit of Quantification (LoQ) is meticulously calibrated at 125 total copies for both the reference gene ABL1 and the chromosomal rearrangement inv(16)(p13q22), thereby ensuring high fidelity in molecular quantification.

The kit is capable of achieving a theoretical sensitivity level of MR4:0.01%, a critical metric for the detection of Minimal Residual Disease (MRD). It is worth noting that the assay requires 10 µL of cDNA, synthesized by reverse transcription of total RNA extracted from peripheral blood samples.

Five Reasons to Choose This Kit: Unmatched Capabilities

  1. Precise Gene Identification: Amplifies and quantifies the type A CBFB-MYH11 fusion gene with high specificity.
  2. Elevated Sensitivity: Theoretical sensitivity levels extend down to MR4:0.01%.
  3. Regulatory Adherence: Rigorously compliant with established research protocols.
  4. Comprehensive Data Output: Enables the calculation of gene copies for both the rearrangement and endogenous gene ABL1.
  5. MRD Capacity: Offers utility in detecting Minimal Residual Disease.

The Final Word: Why This Kit Is a Game-Changer in AML Research

The CBFB-MYH11 Kit is an indomitable tool in the realm of molecular diagnostics for AML, crafted for professionals in the field. Offering unparalleled levels of accuracy, sensitivity, and regulatory compliance, the kit provides a comprehensive suite of capabilities that extend from gene identification to MRD detection. This tool is not merely an addition to the molecular biologist’s repertoire; it sets a new standard for AML diagnostic and prognostic assessment.

The kit contents the necessary reagents to perform 48 reactions. The reagents included in the kit are the following:

  •  INV16 Master Mix: Specific oligonucleotides, labelled probes and water reagents for the PCR
    reactions.
  • ABL1 Master Mix: Specific oligonucleotides, labelled probes and water reagents for the PCR
    reactions.
  • INV16-ABL1 Standard: Positive control for INV16 rearrangement and ABL gene
Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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