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

DR version contains 20 reactions and RTU version contains 12 reactions

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

Genomic target:

KIT – D816V (l1)

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

KIT – D816V (l1)                                                                 5800                                                5581

SensiScreen^® Liquid KIT qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the KIT D816V Mutational Status.

The product variant (l1) is supplied as a Dispense Ready (DR) and a Ready-to-Use (RTU) version. The DR version includes oligonucleotide mixtures and Master Mix in separate tubes which need to be dispensed into suitable plasticware before addition of template. The RTU version is pre-dispensed in PCR strip tubes and only need the addition of template before real-time qPCR amplification.

SensiScreen^® Liquid 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^® Liquid KIT qPCR Assay is based on PentaBase’s unique DNA technologies (referred to as pentabases™), which are synthetic DNA analogues comprising a flat heteroaromatic, hydrophobic molecule and a linker. They are inserted into the oligonucleotides at fixed positions during synthesis of the oligonucleotides. The SensiScreen^® Liquid KIT qPCR Assay contain both standard oligonucleotides and pentabases™-modified oligonucleotides.

Intended purpose:
SensiScreen^® Liquid KIT qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of the specific somatic mutation D816V in the human KIT proto-oncogene (KIT) gene in cell-free DNA (cfDNA) purified from liquid biopsies including plasma. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows.

The assay is an in vitro diagnostic medical device intended for patients already diagnosed with KIT mutation to aid in disease monitoring based on KIT mutation status. The test result correlates with the amount of KIT mutant cfDNA. Results can be used to determine changes in KIT mutation quantity levels in patients over time such as during cancer interventions or during follow-up. It is not intended as a companion diagnostic device.

Intended user:
SensiScreen^® Liquid KIT qPCR Assay is intended to be used 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 authorization.

Procedure                                                                 Designed to run on open platforms with at least
                                                                                    two-channels (green and yellow).

Validated Real-Time PCR instruments                 MyGo Pro and ABI 7500 real-time PCR instruments

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                                                        D816V of the human KIT

Sample types                                                           Liquid

Sample DNA extraction methods                         cfDNA extraction kits and/or procedures specially
                                                                                    designed for handling of liquid biopsies samples
                                                                                    according to the manufacturer´s instructions

Sample input                                                            5 ng DNA or less per reaction

PCR run time                                                            Less than 2 hours

The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS014