Imegen-NPM1

Detection of the most frequent insertion mutations (subtypes A, B and D) in exon 12 of the NPM1 gene associated with Acute Myeloid Leukemia with normal cytogenetics (CN-AML)

24 rxn

Real-time PCR

IMG-235

7500 FAST Real-Time PCR System (ThermoFisher), StepOne Real-Time PCR System (Thermo Fisher), CFX96 Real-Time PCR System (BioRad)

  • Multiplex assay that allows simultaneous amplification of the most frequent insertion variants (subtypes A, B and D) in exon 12 of the NPM1 gene.
  • The results obtained in this test allow to confirm the diagnosis of the patient. This assay is not optimal for the study of minimal residual disease (MRD) in AML patients.
  • The detection limit has been set at 10%.
  • Includes an endogenous control to confirm sample quality and integrity.
  • It includes a positive control that allows the amplification of the NMP1-Type A variant, which guarantees the functionality of the PCR system.
  • It complies with the quality requirements specified by ISO 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
  • For in vitro diagnostic use.

This assay uses a combination of oligonucleotides and fluorescent hydrolysis probes in a validated assay to detect the presence of mutations in the NPM1 gene along with the endogenous gene, b-globin, in a genomic DNA sample.

  • Amount of DNA: 50 ng total
  • Sample type: Peripheral blood (Germinal)
  • Number of reactions per sample: 1
  • Number of targets: 3
  • Manual working time: 30 min
  • Duration of the PCR program: 1 h
  • Compatible cyclers: real-time PCR cycler with FAMTM and VIC®

Imegen-NPM1

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