PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay

The PlentiPlex MYD88 qPCR Assay combines high sensitivity with ease-of-use and is designed to work on standard real-time PCR equipment. The PlentiPlex MYD88 L265P assay is based on PentaBase’s novel and selective INA® technologies including the use of BaseBlockers™ that suppress false positive PCR signals from wild type templates.

  • Open qPCR instrument procedure
  • 0.6-0.75% MYD88 L265P LOD
  • Results in less than 2 hours
  • Based on INA® technology
  • Minimal hands-on time
  • CE IVD
Product Details

Reference Number                                                   1500, 1849

Product Name                                                           PlentiPlex™ MYD88Waldenström Lymphoma qPCR Assay

Product Description                                                 PCR master mix and oligonucleotide mix for quantification of MYD88 L265P mutation, positive control

Format                                                                        Ready-to-Use, Dispense Ready

Reactions                                                                   12, 20

Intended Use

PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay is a semi-quantitative real-time Polymerase Chain Reaction (PCR) assay intended for in vitro diagnosis of the genomic DNA (gDNA) change giving rise to leucine to proline mutation in codon 265 (L265P) of the Myeloid differentiation primary response 88 (MYD88).

Samples shall be obtained from Formalin-Fixed Paraffin-Embedded (FFPE) tissue or blood samples. The assay is used with real-time PCR systems and samples can be prepared using automated platforms or in manual workflows. The obtained results of PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay are intended for identification of the presence of the MYD88 L265P, facilitating discrimination between Lymphoplasmacytic lymphoma/Waldenström macroglobulinemia (LPL/WM) and non-Hodgkin lymphoma.

PlentiPlex™ MYD88 Waldenström Lymphoma qPCR Assay is intended for use by healthcare professionals or qualified laboratory personnel instructed and trained in the techniques of real-time qPCR as well as proficient in handling biological samples. Medical interventions based on results from this product requires medical authorisation.

Product Specifications

Procedure                                                                  Real-time PCR-based

Compatible real-time PCR instruments                Open platform design compatible with standard real-time PCR instruments

PentaBase technologies                                         BaseBlocker™, HydrolEasy® Probe, SuPrimer™

Genomic target                                                         MYD88 L265P (c.794T>C)

Sample types                                                            FFPE and whole blood samples

Sample DNA extraction methods                          Relevant commercially avaliable FFPE or whole blood DNA extraction kits

Sample input                                                             1-10 ng/µL of purified DNA

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/PP004

Publications

PlentiPlex™ MYD88 Waldenström lymphoma qPCR assay: A highly sensitive method for detection of MYD88 L265P mutation

Viscovo et al. – Int J Lab Hematol. – 2024

Read article

Related files

File
File name
Size
pdf
Data sheet
MSDS Plentiplex MYD88 v2.0
141 KB
pdf
PlentiPlex MYD88 Flyer v1.1

Assisting the Stratification of Lymphomas

The PlentiPlex MYD88 L265P assay is intended for in vitro diagnosis of the leucine to proline mutation in codon 265 of the Myeloid differentiation primary response 88 protein (MYD88 L265P) in genomic DNA (gDNA) samples. The obtained results of the PlentiPlex MYD88 L265P assay are intended for assisting in the discrimination between patients with Lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia (LPL/WM) and other non-Hodgkin lymphomas.

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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