PlentiPlex™ KIT Mastocytosis qPCR Assay, CE IVD
PlentiPlex™ KIT Mastocytosis qPCR Assay is based on PentaBase’s INA® technology including BaseBlockers™ that allows for ultra-sensitive detection of low variant KIT D816V allele frequency mutations with a limit of detection (LOD) of just 0.005% in genomic DNA purified from whole blood.
The obtained results of PlentiPlex™ KIT Mastocytosis qPCR Assay are intended for the identification of the KIT D816V mutation as part of the WHO diagnostic criteria to assist the diagnosis of Mastocytosis.
- Open qPCR instrument procedure
- Results in less than 2 hours
- Based on INA® technology
- 0.005% KIT D816V LOD
- Minimal hands-on time
- 5-300 ng input DNA
- CE IVD
- CE IVDR expected in Q4 2025
Product Details
Product Description:
PCR master mix and oligonucleotide mix for quantification of KIT D816V mutation, positive control
PlentiPlex™ KIT Mastocytosis qPCR Assay:
20 reactions DR: 7032
12 reactions RTU: 7030
Intended Use
PlentiPlex™ KIT Mastocytosis qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for in vitro diagnosis of the genomic change giving rise to the aspartic acid to valine mutation in codon 816 of the human KIT proto-oncogene receptor tyrosine kinase (KIT D816V). Samples are genomic DNA (gDNA) purified from blood samples.
The obtained results of PlentiPlex™ KIT Mastocytosis qPCR Assay are intended for the identification of the presence and/or quantity of the KIT D816V mutation as part of the World Health Organization (WHO) diagnostic criteria to assist the diagnosis of Mastocytosis.
PlentiPlex™ KIT Mastocytosis qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization.
Product Specifications
Procedure:
Real-time PCR-based
Compatible real-time PCR instruments:
Open platform design compatible with Standard real-time PCR instruements
PentaBase technologies:
BaseBlocker™, HydrolEasy® Probe, SuPrimer™
Genomic target:
KIT D816V (c.2447A>T)
Whole blood samples
Sample DNA extraction methods:
Relevant commercially avaliable whole blood DNA extraction kits
Sample input:
1-60 ng/µL of purified DNA
PCR run time:
Less than 2 hours
Instructions For Use
For the latest version of the Instructions For Use (IFU) – Click here –
Publications
Clinical validation of a new commercial highly sensitive KIT D816V mutation analysis in mastocytosis
Kristensenen et al. – Allergy – 2020
Related files
