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

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® FFPE KRAS qPCR Assay targets one or more mutation(s) in exon 2, 3 and 4 of the human Kirsten Rat Sarcoma virus (KRAS) gene

Genomic targets:

EXON 2+3+4 Multiplex (K1 )
EXON 2 Multiplex (K2)
EXON 3 Multiplex (K3)
EXON 4 Multiplex (K4)
EXON 2 Simplex 1 (K5)
EXON 2 Simplex 2 (K6)
EXON 3 Simplex 1 (K7)
EXON 3 Simplex 2 (K8)
EXON 4 Simplex 1 (K9)
EXON 4 Simplex 2 (K10)
EXON 2 G12C Simplex (K11)

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

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EXON 2+3+4 Multiplex (K1)                                             1900                                                1701

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EXON 2 Multiplex (K2)                                                      1905                                                1706

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EXON 3 Multiplex (K3)                                                      1910                                                1711

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EXON 4 Multiplex (K4)                                                      1915                                                1716

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EXON 2 Simplex 1 (K5)                                                     1925                                                1726

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EXON 2 Simplex 2 (K6)                                                     1930                                                1731

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EXON 3 Simplex 1 (K7)                                                     1940                                                1741

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EXON 3 Simplex 2 (K8)                                                     1945                                                1746

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EXON 4 Simplex 1 (K9)                                                                                                              1756

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EXON 4 Simplex 2 (K10)                                                                                                            1761

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EXON 2 G12C Simplex (K11)                                           1955                                                1960

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

SensiScreen^® FFPE KRAS Assay product variants include the complete range of targeted KRAS mutations (multiplex product variant K1) or target specific gene mutations in KRAS exon 2, 3 or 4 (simplex and/or multiplex product variants K2-K11).

Each product variant is in addition supplied as both 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 KRAS 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 KRAS 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 KRAS qPCR Assay contains both standard and INA^® oligonucleotides.

Intended purpose:
SensiScreen^® FFPE KRAS qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic KRAS proto-oncogene (KRAS) 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 KRAS qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the KRAS somatic mutational status for stratification. It is not intended as a companion diagnostic device.

Intended user:
SensiScreen^® FFPE KRAS 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 – Designed to run on open platforms with a
                                                                                    minimum of two-channels (green and yellow)

Validated Real-Time PCR instruments                 MyGo Pro (IT’IS Life Science), Rotor-Gene Q (Qiagen),
                                                                                    CFX96 (Bio-Rad) and Mx3005P (Agilent)

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 12, 13, 59, 61, 117 and 146 of the human KRAS
                                                                                    gene

Sample types                                                           Solid biopsies (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/SS005

Riva et al. – PLoS One – 2017 – Click here for article