- 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.
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