MicroSight® MSI 1-Step HRM Analysis Assay

MicroSight® MSI is a simple and fast method for evaluating microsatellite instability (MSI) status of human DNA. The analysis is based on PentaBase’s proprietary INA® technology that enables fast and easy detection of microsatellite instability status by real-time PCR and high-resolution melt (HRM) analysis.

MicroSight® MSI requires very little hands-on time and enables evaluation of patient microsatellite status of purified human genomic DNA in less than one and a half hours for fast treatment guidance of cancer patients.

MicroSight® MSI can be used for analysis of both paired and unpaired tumour samples. Evaluation of unpaired tumour samples is done by comparison to an included universal reference. Up to 7 unpaired tumour samples can be analysed in each real-time PCR run.

  • Used with BaseTyper 48.4 real-time PCR system
  • Paired and unpaired sample analysis
  • Semi-automatic objective analysis
  • Results in less than 2 hours
  • Minimal hands-on time
  • CE IVD
Product Details

Reference Number                                                   7201

Product Name                                                           MicroSight® MSI 1-Step HRM Analysis

Product Description                                                 PCR master mix and oligonucleotide mix for evaluation of MSI status of BAT25, BAT26, NR22 and MONO27, universal reference, positive and negative control

Format                                                                        Ready-to-Use

Reactions                                                                   16

Intended Use

MicroSight® MSI 1-step HRM analysis is based on Real-Time Polymerase Chain Reaction (RT-PCR) followed by high-resolution melt (HRM) study on a BaseTyper™ 48.4 Quiet HRM Real-Time PCR System. The assay is intended for the qualitative evaluation of microsatellite stability (MSS)/instability (MSI), in human DNA from solid biopsies such as Formalin-Fixed Paraffin-Embedded (FFPE) tissue. MSI is known as a prognostic marker and a predictive factor of response to certain therapies like check point inhibitors and 5-fluorouracil.

MicroSight® MSI 1-step HRM analysis is an in vitro diagnostic medical device intended as an aid to correct treatment selection. The assay is intended for use by healthcare professionals or qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR, HRM measurements as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorization. [EN]

Product Specifications

Procedure                                                                  Real-time PCR HRM-based

Validated Real-Time PCR instruments                 BaseTyper™ 48.4 Quiet HRM Real-Time PCR System (PentaBase Ref. No. 754)

PentaBase technologies                                         EasyBeacon™, SuPrimer™

Genomic targets                                                       BAT25, BAT26, NR22 and MONO27 microsatellites

Sample types                                                            Solid colorectal and endometrial cancer biopsies including formalin-fixed paraffin-embedded (FFPE) tissue samples

Sample tumor cell percentage                               At least 20%

Sample DNA extraction methods                          Relevant commercially avaliable solid biospy/FFPE DNA extraction kits

Sample input                                                             1-10 ng/µL of purified DNA directly from the sample that has not been otherwise chemically manipulated

PCR run time                                                             Less than 2 hours

Instructions For Use

The latest version of the Instructions For Use can be found at: www.5ba.se/MS001

Publications

One-instrument, objective microsatellite instability analysis using high-resolution melt

Bendixen et al. – PLoS One – 2024

Read article

Related files

File
File name
Size
pdf
MSDS MicroSight MSI V3.0
141 KB
pdf
MicroSight MSI Flyer

Semi-automatic Analysis of Well-establised Micro-satellite Loci

MicroSight® MSI evaluates instability of the well-established microsatellite markers BAT25, BAT26, NR22, NR24 and MONO27 allowing for easy conversion from current methods based on capillary electrophoresis.

The BaseTyper software automatically calls each locus either stable (MSS) or unstable (MSI) based on the generated HRM difference plot and defined threshold for each locus.

INA®-based IVD PCR assays with superior performances

Our IVD PCR assays are based on a unique INA® oligonucleotide chemistry with superior target affinity and specificity. The INA®-based IVD PCR assay portfolio including SensiScreen®, PlentiPlex™ and EpiDirect® product families offer excellent performances, are easy to implement in standard laboratory workflows and provide results in a couple of hours.

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