Oncology & Haematology > HaemOnc Individual Markers > IDH 1/2

IDH1/2 Mutation Detection and Differentiation Kit | CE-IVD

Oncology & Haematology > HaemOnc Individual Markers > IDH 1/2

IDH1/2 Mutation Detection and Differentiation Kit | CE-IVD

Product highlights

  • CE-IVD certified for clinical use
  • Detects and differentiates key IDH1/2 mutations
  • Validated on major Real-Time PCR instruments
  • Includes all reagents and controls for streamlined workflow

IDH1/2 Mutation Detection and Differentiation Kit | CE-IVD

About IDH1/2 Mutation Detection and Differentiation Kit | CE-IVD

The TRUPCR® IDH1/2 Detection & Differentiation Kit enables sensitive and reliable detection of IDH1/2 mutations in DNA extracted from blood, bone marrow, or FFPE tissue using Real-Time PCR. Designed for molecular diagnostics in AML and gliomas, the kit offers CE-IVD certification, includes internal controls, and works across a range of PCR platforms. Its rapid workflow and high specificity make it ideal for routine use in clinical laboratories seeking accurate, mutation-specific results.

Specifications of the IDH1/2 Mutation Detection and Differentiation Kit | CE-IVD

What is IDH1/2?

IDH1 and IDH2 are genes encoding the isocitrate dehydrogenase enzymes, crucial in cellular metabolism. These genes are frequently mutated in various cancers, including gliomas and acute myeloid leukemia (AML). IDH1 is cytoplasmic, while IDH2 resides in the mitochondria, and both play a key role in the conversion of isocitrate to alpha-ketoglutarate.

Mutations in these genes disrupt normal function and lead to the production of an oncometabolite, 2-hydroxyglutarate (2-HG), which affects epigenetic regulation and contributes to cancer development.

Role of IDH1/2 Mutations in Disease

In AML, IDH1 and IDH2 mutations occur in approximately 7–19% of cases and are linked to normal karyotype AML, a subgroup with significant genetic variability. These mutations can be prognostically significant, influencing survival and treatment response in diverse patient populations.

IDH mutations are also common in gliomas: over 80% of low-grade gliomas and secondary glioblastomas carry mutations in IDH1 or IDH2. Their presence is associated with improved prognosis, making them valuable diagnostic and therapeutic biomarkers in neuro-oncology.

About the TRUPCR® IDH1/2 Detection & Differentiation Kit

The TRUPCR® IDH1/2 Detection & Differentiation Kit is an in vitro diagnostic tool for the qualitative detection of somatic mutations in IDH1 and IDH2. It is validated for genomic DNA extracted from EDTA-treated blood, bone marrow, and FFPE tissue samples. The kit is CE-IVD certified, making it suitable for clinical use.

It includes all necessary reagents, including mutation-specific primers and fluorescent probes, as well as an internal control to detect PCR inhibition and ensure assay reliability.

The kit supports a wide range of Real-Time PCR instruments including:

  • Applied Biosystems™ 7500 and QuantStudio® series
  • Rotor-Gene Q
  • Bio-Rad CFX Series

A variant is also available for IDH1-only mutation detection.

Principle and Workflow

The assay uses ARMS PCR (Amplification Refractory Mutation System), enabling allele-specific amplification. Taq DNA polymerase selectively amplifies mutated sequences with high specificity. Mutations such as IDH1 R132, R100, and IDH2 R140, R172 are targeted.

The fluorescent signal is generated by sequence-specific probes labeled with FAM (target detection) and VIC/HEX (internal control). The probes are cleaved during extension, separating the quencher from the fluorophore and allowing real-time detection of amplification.

Internal controls monitor the DNA extraction process and detect potential PCR inhibition, reducing false negatives.

Clinical Application

The TRUPCR® IDH1/2 Detection & Differentiation Kit supports diagnostic workflows in:

  • Acute Myeloid Leukemia (AML): Detects clinically relevant IDH mutations with prognostic significance.
  • Gliomas: Helps stratify patients by mutation status, supporting therapeutic decisions and clinical trial eligibility.

Fast and cost-effective, the kit enables early and accurate molecular diagnosis critical for patient management and outcome.

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