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:

EXON 2+3+4 Multiplex (K1):
20 reactions DR: 1900
12 reactions RTU: 1701

EXON 2 Multiplex (K2):
20 reactions DR: 1905
12 reactions RTU: 1706

EXON 3 Multiplex (K3):
20 reactions DR: 1910
12 reactions RTU: 1711

EXON 4 Multiplex (K4):
20 reactions DR: 1915
12 reactions RTU: 1716

EXON 2 Simplex 1 (K5):
20 reactions DR: 1925
12 reactions RTU: 1726

EXON 2 Simplex 2 (K6):
20 reactions DR: 1930
12 reactions RTU: 1731

EXON 3 Simplex 1 (K7):
20 reactions DR: 1940
12 reactions RTU: 1741

EXON 3 Simplex 2 (K8):
20 reactions DR: 1945
12 reactions RTU: 1746

EXON 4 Simplex 1 (K9):
12 reactions RTU: 1756

EXON 4 Simplex 2 (K10):
12 reactions RTU: 1761

EXON 2 G12C Simplex (K11):
20 reactions DR: 1955
12 reactions RTU: 1960

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 conclusions 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

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

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