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

NRAS exon 2+3+4 Multiplex (N1):
20 reactions DR: 2000
12 reactions RTU: 1771

NRAS exon 2 Multiplex (N2):
20 reactions DR: 2005
12 reactions RTU: 1776

NRAS exon 3 Multiplex (N3):
20 reactions DR: 2010
12 reactions RTU: 1781

NRAS exon 4 Multiplex (N4):
20 reactions DR: 2015
12 reactions RTU: 1786

NRAS exon 2 Simplex 1 (N5):
20 reactions DR: 2025
12 reactions RTU: 1796

NRAS exon 2 Simplex 2 (N6):
20 reactions DR: 2030
12 reactions RTU: 1801

NRAS exon 3 Simplex 1 (N7):
20 reactions DR: 2040
12 reactions RTU: 1811

NRAS exon 3 Simplex 2 (N8):
20 reactions DR: 2045
12 reactions RTU: 1816

NRAS exon 4 Simplex 1 (N9):
20 reactions DR: 2050
12 reactions RTU: 1821

NRAS exon 4 Simplex 2 (N10):
20 reactions DR: 2055
12 reactions RTU: 1826

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 conclusions 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

For the latest version of the Instructions For Use (IFU) – Click here –