
SensiScreen® FFPE BRAF qPCR Assay
SensiScreen® FFPE BRAF qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the BRAF V600 Mutational Status
- 0.2-1.9% limit of detection (LOD)
- 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 MyGo Pro (IT-IS Life Science), Mx3000P (Agilent) and CFX96 (Bio-Rad) 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® FFPE BRAF qPCR Assay targets one or more mutations in codon 600 of the human BRAF gene.
Genomic targets:
BRAF V600 Multiplex (V600D; V600E+E2; V600K; V600R) (B1)
BRAF V600 Simplex (V600D; V600E; V600K; V600R) (B2)
BRAF V600E Simplex (V600E) (B3)
Product Details
SensiScreen® FFPE BRAF qPCR Assay Reference number Reference number
Dispense Ready (DR) Ready-To-Use (RTU)
20 reactions 12 reactions
BRAF V600 Multiplex (B1) 1398 1831
BRAF V600 Simplex (B2) 1402 1836
BRAF V600E Simplex (B3) 1400 1841
Product Description
SensiScreen® FFPE BRAF qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the BRAF V600 Mutational Status.
SensiScreen® FFPE BRAF qPCR Assay product variants include the complete range of targeted BRAF V600 mutations in a multiplex format (product variant B1) and simplex format (product variant B2) or specifically target the BRAF V600E variant (product variant B3).
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 BRAF 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 BRAF 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 BRAF qPCR Assay contains both standard and INA® oligonucleotides.
Intended Use
Intended purpose:
SensiScreen® FFPE BRAF qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the semi-quantitative detection of specific somatic v-Raf murine sarcoma viral oncogene homolog B (BRAF) 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 BRAF qPCR Assay is an in vitro diagnostic medical device intended to detect, identify, and quantify the EGFR somatic mutational status for stratification. It is not intended as a companion diagnostic device.
Intended user:
SensiScreen® FFPE BRAF 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 interventions based on results from this product require medical authorisation.
Product Specifications
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 Mx3000P™ (Agilent), 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 Codon 600 of the human BRAF gene
Sample types 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
Instructions For Use
The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS001
Related files
