SensiScreen® Liquid KRAS qPCR Assay
SensiScreen® Liquid KRAS qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the EGFR Mutational Status.
- Low input requirements (less than 5 ng DNA/reaction)
- Run Time in less than 2 hours
- Based on INA® technology
- Ready-to-Use optionality
- Minimal hands-on time
- Open platform design*
*Compatible with most Real-Time PCR Systems including Agilent, Applied Biosystems, Bio-Rad, BMS, Qiagen and Roche. Validated on BaseTyper™ (PentaBase) and MyGo Pro (IT-IS Life Science) Real-Time PCR Systems.
Format
Dispense Ready (DR) and Ready-to-Use (RTU)
Number of Reactions
DR version contains 20 reactions and RTU version contains 12 reactions
Analysis
SensiScreen® Liquid 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)
Product Details
SensiScreen® Liquid KRAS qPCR Assay Reference number Reference number
Dispense Ready (DR) Ready-To-Use (RTU)
20 reactions 12 reactions
EXON 2+3+4 Multiplex (K1) 5395 5210
EXON 2 Multiplex (K2) 5400 5206
EXON 3 Multiplex (K3) 5405 5211
EXON 4 Multiplex (K4) 5410 5216
EXON 2 Simplex 1 (K5) 5420 5226
EXON 2 Simplex 2 (K6) 5425 5231
EXON 3 Simplex 1 (K7) 5435 5241
EXON 3 Simplex 2 (K8) 5440 5246
EXON 4 Simplex 1 (K9) 5450 5256
EXON 4 Simplex 2 (K10) 5455 5261
Product Description
SensiScreen® Liquid KRAS qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the KRAS Mutational Status.
SensiScreen® Liquid KRAS Assay product variants include the complete range of targeted KRAS mutations (multiplex product variant K1) or target specific EGFR gene mutations in KRAS exon 2, 3 or 4 (simplex and multiplex product variants K2-K10).
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 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® Liquid 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® Liquid KRAS qPCR Assay contains both standard and INA® oligonucleotides.
Intended Use
Intended purpose: SensiScreen® Liquid KRAS qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of specific somatic KRAS proto-oncogene (KRAS) gene mutations in cell-free DNA (cfDNA) purified from liquid biopsies including plasma and serum for research use 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 KRAS mutation to aid in disease monitoring based on KRAS mutation status. The test result correlates with the amount of BRAF mutant cfDNA. Results can be used to determine changes in BRAF 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 KRAS 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.
Product Specifications
Procedure Designed to run on open platforms with at least
two-channels (green and yellow).
Validated Real-Time PCR instruments MyGo Pro, BaseTyper™ 48.4 Quiet HRM real-time PCR
instruments
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 KRAS
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
Instructions For Use
The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS006
Related Files
