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NPM1 Qualitative KIT
The TRUPCR® NPM1 Qualitative Kit is an in vitro real-time PCR assay developed for the qualitative detection of NPM1 mutations-specifically Types A (c.860_863dupTCTG), B (c.863_864insCATG), and D (c.863_864insCCTG)-from peripheral blood samples of patients with suspected acute myeloid leukemia (AML). The kit uses fluorescent probes and a two-tube format to ensure reliable detection and includes a reference control gene for normalization. With 1% mutant allele sensitivity, this assay supports early diagnosis, risk stratification, and clinical decision-making in AML.
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This kit in detail
The TRUPCR® NPM1 Qualitative Kit is an in vitro real-time PCR assay developed for the qualitative detection of NPM1 mutations-specifically Types A (c.860_863dupTCTG), B (c.863_864insCATG), and D (c.863_864insCCTG)-from peripheral blood samples of patients with suspected acute myeloid leukemia (AML). The kit uses fluorescent probes and a two-tube format to ensure reliable detection and includes a reference control gene for normalization. With 1% mutant allele sensitivity, this assay supports early diagnosis, risk stratification, and clinical decision-making in AML.
- Detects NPM1 A, B & D mutations in a single qualitative real-time PCR run
- High sensitivity – detects 1% mutant allele in wild-type background
- Two-tube design with internal reference control for result accuracy
- Compatible with major qPCR instrument
Qualitative PCR Detection of NPM1 A, B & D Mutations in Acute Myeloid Leukemia (AML)
The TRUPCR® NPM1 Qualitative Kit is a sensitive, CE-IVD certified in vitro diagnostic assay developed for the qualitative detection of NPM1 gene mutations, specifically Type A (c.860_863dupTCTG), Type B (c.863_864insCATG), and Type D (c.863_864insCCTG). The assay uses real-time PCR with fluorescent probes and is based on a two-tube format that includes a mutation-specific primer-probe mix and an internal control gene. The kit is intended for use with genomic DNA extracted from peripheral blood samples and supports diagnosis, risk classification, and clinical decision-making in patients with acute myeloid leukemia (AML).
Molecular Background
Acute myeloid leukemia (AML) is a genetically diverse malignancy of the bone marrow characterized by clonal expansion of immature myeloid cells. One of the most frequently mutated genes in AML is Nucleophosmin 1 (NPM1), found in approximately 35% of all AML patients and in up to 60% of cytogenetically normal AML (CN-AML) cases.
NPM1 is a multifunctional protein located primarily in the nucleolus, playing essential roles in ribosome biogenesis, histone chaperoning, and pre-ribosomal transport. Mutations, predominantly found in exon 12, lead to a frame-shift and creation of a new nuclear export signal, resulting in aberrant cytoplasmic localization of NPM1 (NPM1c+)-a key hallmark of the disease.
Over 50 NPM1 variants have been described, but more than 95% of cases involve the same region, particularly:
- Type A (c.860_863dupTCTG) – the most common
- Type B (c.863_864insCATG)
- Type D (c.863_864insCCTG)
These mutations are considered early initiating events and play a significant role in AML pathogenesis and prognosis. Importantly, NPM1 mutations are associated with favorable outcomes, especially in the absence of FLT3-ITD, and have become a standard molecular marker in AML classification.
Assay Performance & Utility
The TRUPCR® NPM1 Qualitative Kit enables accurate and sensitive detection of the most clinically relevant NPM1 mutations in a single real-time PCR workflow. The assay supports:
- Initial diagnosis and molecular classification of AML
- Detection of low-level mutations with a sensitivity of 1% mutant allele
- Stratification of AML patients into prognostic groups
- Monitoring of residual disease in follow-up settings
The kit is optimized for use in routine diagnostic laboratories, providing fast, reproducible results and compatibility with widely used real-time PCR platforms.
Technical Specifications
The TRUPCR® NPM1 Qualitative Kit is a two-tube real-time PCR assay using fluorescent probe-based detection. It is designed to amplify regions of exon 12 of the NPM1 gene, where mutations A, B, and D occur, and includes a reference control gene for result validation.
- Sample Type: Genomic DNA from peripheral blood
- Input Requirement: 50–200 ng DNA per reaction
- Target Mutations: NPM1 A, B, and D (exon 12)
- Detection Method: TaqMan-based real-time PCR
- Sensitivity: Detects down to 1% mutant allele in a wild-type background
- Assay Format: Two-tube system (mutation + internal control)
- Time to Result: ~90 minutes
- Instrument Compatibility: ABI 7500, Bio-Rad CFX96™, Roche LightCycler®, and similar systems
- Primer Probe Mix 1
- Primer Probe Mix 2
- Positive Control
- Negative Control
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Product Catalogus
Frequently paired with this kit
Other assays and instruments lab teams add alongside the NPM1 Qualitative KIT.
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