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

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® Liquid 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^® Liquid 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)                                   5460                                                5271

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NRAS exon 2 Multiplex (N2)                                            5465                                                5276

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NRAS exon 3 Multiplex (N3)                                            5470                                                5281

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NRAS exon 4 Multiplex (N4)                                            5475                                                5286

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NRAS exon 2 Simplex 1 (N5)                                           5485                                                5296

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NRAS exon 2 Simplex 2 (N6)                                           5490                                                5301

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NRAS exon 3 Simplex 1 (N7)                                           5500                                                5311

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NRAS exon 3 Simplex 2 (N8)                                           5505                                                5316

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NRAS exon 4 Simplex 1 (N9)                                           5515                                                5326

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NRAS exon 4 Simplex 2 (N10)                                         5520                                                5331

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

SensiScreen^® Liquid 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 supplied as both a Dispense Ready (DR) 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^® Liquid 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^® Liquid 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^® Liquid NRAS qPCR Assay contains both standard and INA^® oligonucleotides

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

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

Intended user:
SensiScreen^® Liquid NRAS 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 real-time PCR instruments

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

Genomic targets                                                      Codons 12, 13, 59, 61, 117 and 146 of the human NRAS
                                                                                    gene

Sample types                                                           Liquid

Sample DNA extraction methods                         cfDNA extraction kits and/or procedures specially
                                                                                    designed for handling of liquid biopsy 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/SS008