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Oncology & Haematology · NPM1
Healthincode Distributed by Goffin Diagnostics

CBFB-MYH11 Kit

The CBFB-MYH11 Kit identifies and quantifies the CBFB-MYH11 fusion gene, which results from the chromosomal rearrangement inv(16)(p13q22) and is used in the diagnosis and prognosis of acute myeloid leukaemia. The assay quantifies the type A variant, which accounts for 85 per cent of cases, alongside the endogenous reference gene ABL1. One kit covers 48 reactions for each of the two targets. Research use only.

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

  • Quantification of the CBFB-MYH11 type A fusion, inv(16)(p13q22)
  • ABL1 as endogenous reference gene, quantified in parallel
  • Reference plasmid for copy number calculation of both targets
  • Limit of quantification 125 total copies for ABL1 and for the rearrangement
  • Theoretical sensitivity MR4, 0.01 per cent, for minimal residual disease
  • 10 µL of cDNA per reaction, from reverse transcription of total RNA
  • 48 reactions per target

The CBFB-MYH11 Kit detects and quantifies the CBFB-MYH11 fusion gene by real-time PCR. The fusion results from the chromosomal rearrangement inv(16)(p13q22) and is used in the diagnosis and the prognosis of acute myeloid leukaemia.

Target

The assay amplifies and quantifies the type A variant of the fusion, which accounts for 85 per cent of cases, using target-specific oligonucleotides and hydrolysis probes.

Quantification

A reference plasmid is used to calculate the copy number of the rearrangement and of the endogenous gene ABL1, so the result can be expressed as a ratio. The limit of quantification is 125 total copies, both for ABL1 and for the rearrangement.

Minimal residual disease

The theoretical sensitivity is MR4, corresponding to 0.01 per cent, which is the level relevant to the follow-up of minimal residual disease.

Sample

Each reaction requires 10 µL of cDNA, obtained by reverse transcription of total RNA.

Regulatory status

This kit is for research use only.

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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