Dispense Ready (DR) and Ready-to-Use (RTU)

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® Liquid BRAF qPCR Assay targets one or more mutation(s) 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)

SensiScreen^® Liquid BRAF qPCR Assay:

BRAF V600 Multiplex (B1):
20 reactions DR: 5525
12 reactions RTU: 5336

BRAF V600 Simplex (B2):
20 reactions DR: 5530
12 reactions RTU: 5341

BRAF V600E Simplex (B3):
20 reactions DR: 5535
12 reactions RTU: 5346

SensiScreen^® Liquid BRAF qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the BRAF V600 Mutational Status.
SensiScreen^® Liquid 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 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 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^® Liquid 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^® Liquid BRAF qPCR Assay contains both standard and INA^® oligonucleotides.

Intended purpose:
SensiScreen^® Liquid BRAF qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for the detection, identification, and relative quantification of specific somatic mutations in the human v-Raf murine sarcoma viral oncogene homolog B (BRAF) gene in cell-free DNA (cfDNA) purified from liquid biopsies including plasma and serum. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The assay is an in vitro diagnostic medical device intended for patients already diagnosed with BRAF mutation to aid in disease monitoring based on BRAF 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 as a companion diagnostic device.

Intended user:
SensiScreen^® Liquid BRAF 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:
Real-time PCR – Assay is 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 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:
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 –