Dispense Ready (DR) and Ready-to-Use (RTU)

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® FFPE KIT qPCR Assay targets one mutation in codon 816 of the human KIT gene

Genomic targets:

KIT – D816V (l1)

SensiScreen^® FFPE KIT qPCR Assay                            Reference number                        Reference number
                                                                                            Dispense Ready (DR)                    Ready-To-Use (RTU)
                                                                                            20 reactions                                   12 reactions

KIT – D816V Simplex (l1)                                                  1154                                                1846

SensiScreen^® FFPE KIT qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the Mutational Status.

SensiScreen^® FFPE KIT Assay Simplex product variants include the KIT – D816V mutation.

The product variant is in addition supplied as a Dispense Ready (DR) version and a Ready-to-Use (RTU) version. DR assays include oligonucleotide mixtures and Master Mix in separate tubes which need to be dispensed into suitable plasticware before addition of template. RTU assays are pre-dispensed in PCR strip tubes and only need the addition of template before real-time qPCR amplification.

SensiScreen^® FFPE KIT qPCR Assay combines allele-specific PCR with PentaBase’s novel and selective technologies comprising both HydrolEasy^® probes, SuPrimers™ and BaseBlockers™ for specific and sensitive target amplification. The SensiScreen^® FFPE KIT qPCR Assay is based on PentaBase’s unique intercalating nucleic acid (INA^®) technology and the inclusion of intercalating pseudonucleotides (IPNs), which are synthetic DNA analogues comprising a flat heteroaromatic, hydrophobic molecule and a linker. IPN molecules are inserted into the oligonucleotides at fixed positions during oligonucleotide synthesis. The SensiScreen^® FFPE KIT qPCR Assay contains both standard and INA^® oligonucleotides.

Intended purpose:
SensiScreen^® FFPE KIT qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic proto-oncogene c-KIT (KIT) gene mutations in human DNA purified from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows.

SensiScreen^® FFPE KIT qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the KIT somatic mutational status for stratification. It is not intended as a companion diagnostic device.

Intended user:
SensiScreen^® FFPE KIT 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 require medical authorisation.

Procedure                                                                 Real-time PCR – Assay is designed to run on open
                                                                                    platforms with at least two-channels (green and yellow)

Validated Real-Time PCR instruments                 MyGo Pro (IT-IS Life Science) and CFX96 (Bio-Rad)

PentaBase technologies                                        Based on our INA^® technology. The mutation-specific
                                                                                    assay contains a HydrolEasy^® probe, a BaseBlocker™, a
                                                                                    mutation-specific primer set and an internal control
                                                                                    assay      

Genomic target                                                        Codon D816 of the human KIT gene

Sample types                                                            FFPE

Sample tumor cell percentage                              At least 20%

Sample DNA extraction methods                         Relevant commercially avaliable solid biospy/FFPE DNA
                                                                                    extraction kits

Sample input                                                            5-50 ng of DNA per reaction (1-10 ng/µL)

PCR run time                                                            Less than 2 hours

The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS013