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

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® FFPE NRAS qPCR Assay targets one or more mutations in exon in exon 2, 3 and 4 of the human NRAS gene

Genomic targets:

NRAS exon 2+3+4 Multiplex (N1 )
NRAS exon 2 Multiplex (N2)
NRAS exon 3 Multiplex (N3)
NRAS exon 4 Multiplex (N4)
NRAS exon 2 Simplex 1 (N5)
NRAS exon 2 Simplex 2 (N6)
NRAS exon 3 Simplex 1 (N7)
NRAS exon 3 Simplex 2 (N8)
NRAS exon 4 Simplex 1 (N9)
NRAS exon 4 Simplex 2 (N10)

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

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NRAS exon 2+3+4 Multiplex (N1)                                   2000                                                1771

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NRAS exon 2 Multiplex (N2)                                            2005                                                1776

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NRAS exon 3 Multiplex (N3)                                            2010                                                1781

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NRAS exon 4 Multiplex (N4)                                            2015                                                1786

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NRAS exon 2 Simplex 1 (N5)                                           2025                                                1796

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NRAS exon 2 Simplex 2 (N6)                                           2030                                                1801

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NRAS exon 3 Simplex 1 (N7)                                           1940                                                1811

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NRAS exon 3 Simplex 2 (N8)                                           2045                                                1816

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NRAS exon 4 Simplex 1 (N9)                                           2050                                                1821

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NRAS exon 4 Simplex 2 (N10)                                         2055                                                1826

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

SensiScreen^® FFPE NRAS Assay product variants include the complete range of targeted NRAS mutations in exon 2, 3 and 4 (product variant N1) or target specific NRAS gene mutations (product variants N2-N10).

Each 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 NRAS 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 NRAS 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 NRAS qPCR Assay contains both standard and INA^® oligonucleotides.

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

Intended user:
SensiScreen^® FFPE NRAS 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                   BaseTyper™ 48.4 (PentaBase), 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                                                        Codons 12, 13, 59, 61, 117 and 146 of the human NRAS
                                                                                    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/SS007