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

DR version contains 20 reactions and RTU version contains 12 reactions

SensiScreen^® Liquid PIK3CA qPCR Assay is supplied as four simplex product variants each one targeting a specific mutation in the human PIK3CA gene.

Genomic targets:

PIK3CA E542K Simplex (P4)
PIK3CA E545K Simplex (P5)
PIK3CA H1047L Simplex (P6)
PIK3CA H1047R Simplex (P7)

SensiScreen^® Liquid PIK3CA qPCR Assay                  Reference number                        Reference number
                                                                                            Dispense Ready (DR)                    Ready-To-Use (RTU)
                                                                                            20 reactions                                   12 reactions

PIK3CA E542K Simplex (P4)                                           5585                                                5591

PIK3CA E545K Simplex (P4)                                           5586                                                5600

PIK3CA H1047L Simplex (P4)                                         5601                                                5592

PIK3CA H1047R Simplex (P4)                                         5587                                                5590

SensiScreen^® Liquid PIK3CA qPCR Assay is an In vitro Diagnostic Assay for Sensitive Detection, Identification and Quantification of the PIK3CA Mutational Status.

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 PIK3CA 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 PIK3CA 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 PIK3CA qPCR Assay contains both standard and INA^® oligonucleotides.

Intended purpose:
SensiScreen^® Liquid PIK3CA 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 phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) 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 manual workflows.
The assay is an in vitro diagnostic medical device intended for patients already diagnosed with PIK3CA mutation to aid in disease monitoring based on PIK3CA mutation status. The test result correlates with the amount of PIK3CA mutant cfDNA. Results can be used to determine changes in PIK3CA 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 PIK3CA 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.

Procedure                                                                 Designed to run on open platforms with at least
                                                                                    two-channels (green and yellow)

Validated Real-Time PCR instruments                BaseTyper™ and CFX96 Touch (Bio-Rad)

PentaBase technologies                                        Based on our INA^® technology. The mutation-specific
                                                                                    assays contain a HydrolEasy^® probe, a BaseBlocker™, a
                                                                                    mutation-specific primer set and an internal control
                                                                                    assay

Genomic target                                                        Codons 542, 545 and 1047 of the human PIK3CA 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/SS010

Kindt et al. – ResearchGate – 2024 – Click here for article