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                      Reference number                        Reference number
                                                                                            Dispense Ready (DR)                    Ready-To-Use (RTU)
                                                                                            20 reactions                                   12 reactions

BRAF V600 Multiplex (B1)                                               5525                                                5336

BRAF V600E, D, K, R Simplex (B2)                                  5530                                                5341

BRAF V600E Simplex (B3)                                               5535                                                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                                                                 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

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

The latest version of the Instructions For Use (IFU) can be found at: https://5ba.se/SS002