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

NRAS exon 2+3+4 Multiplex (N1):
20 reactions DR: 5460
12 reactions RTU: 5271

NRAS exon 2 Multiplex (N2):
20 reactions DR: 5465
12 reactions RTU: 5276

NRAS exon 3 Multiplex (N3):
20 reactions DR: 5470
12 reactions RTU: 5281

NRAS exon 4 Multiplex (N4):
20 reactions DR: 5475
12 reactions RTU: 5286

NRAS exon 2 Simplex 1 (N5):
20 reactions DR: 5485
12 reactions RTU: 5296

NRAS exon 2 Simplex 2 (N6):
20 reactions DR: 5490
12 reactions RTU: 5301

NRAS exon 3 Simplex 1 (N7):
20 reactions DR: 5500
12 reactions RTU: 5311

NRAS exon 3 Simplex 2 (N8):
20 reactions DR: 5505
12 reactions RTU: 5316

NRAS exon 4 Simplex 1 (N9):
20 reactions DR: 5515
12 reactions RTU: 5326

NRAS exon 4 Simplex 2 (N10):
20 reactions DR: 5520
12 reactions RTU: 5331

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^® probe, 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 conclusions 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 biopsies

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

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