Q-PCR Alert Kits – Onco-hematology

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TaqMan® Real-Time PCR

The Philadelphia Q – PCR Alert Kits are quantitative Real-Time reverse-transcription PCR assay for detection of the BCR-ABL rearrangement variants p210 or p190 (also known as t(9;22) translocation, Philadelphia chromosome). They are also used for the quantification of the ratio between BCR-ABL and ABL gene. The products are intended for use in the diagnosis and follow up of chronic myelogenous leukemia (CML), alongside patient clinical data and other laboratory test outcomes. The products follow the ELN guidelines (European Leukemia Net website: www.leukemianet.org/content/home) for the management of CML patients from diagnosis to monitoring of minimal residual disease.

These products are based on TaqMan® technology and feature:

  • UNG (Uracil-N glycosidase) to prevent false positive results
  • Passive reference dye to calibrate the basic fluorescence
  • Internal control to avoid false negative results

All the TaqMan® based assays have a common temperature amplification profile allowing multi target runs on the same instrument at the same time to streamline operations and enhance daily workflow.

TaqMan® is a registered trademark of Roche Molecular Systems, Inc.

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Product Range

The Reagents are sufficient for 24 duplicate determinations for the rearrangement and 24 duplicate determinations for ABL cDNA.

Each kit is composed of mastermix specific to the a region of BCR-ABL rearrangement, mastermix specific to a region of the ABL human gene, microplates and adhesive sheets.

Catalogue Number(s)

RTSG07-210
Product Description: Philadelphia p210 Q – PCR Alert Kit
Number of Tests: 48 x 2
Methodology:

  • Detection of the cDNA BCR-ABL rearrangement variant P210
  • Sample type: Whole blood, Leucocytes suspensions, Lymphomonocyte suspensions
  • Real-Time platform: ABI 7000 series Real-Time PCR System
  • Manual Extraction: EXTRAzol

RTSG07-190
Product Description: Philadelphia p190 Q – PCR Alert Kit
Number of Tests: 48 x 2
Methodology:

  • Detection of the cDNA BCR-ABL rearrangement variant P210
  • Sample type: Whole blood, Leucocytes suspensions, Lymphomonocyte suspensions
  • Real-Time platform: ABI 7000 series Real-Time PCR System
  • Manual Extraction: EXTRAzol

TaqMan® is a registered trademark of Roche Molecular Systems, Inc.

Kits are CE-IVD Marked

Legal Notice:
This product is sold under licensing agreement by F. Hoffmann-La Roche AG

Standards

Philadelphia Q – PCR Standards are composed of 4 stabilized plasmid solution at given titers: 105, 104, 103 and 102. Each vial of ready-to-use standard has a color coded cap that refers to the plasmid’s titer.

Catalogue Number(s)

STDG07-210
Product Description: Philadelphia p210 Q – PCR Standard
Number of Tests: 4 x 2

STDG07-210
Product Description: Philadelphia p190 Q – PCR Standard
Number of Tests: 4 x 2

Kits are CE-IVD Marked

ELITech Molecular Diagnostic also offers a Philadelphia p210 RNA reference kit. This kit provides solution of total RNA to assess the quantification by Real-Time PCR assay of the ratio between BCR-ABL and ABL gene. This product allows establishing the theoretical conversion factor. This factor is a unique and essential tool to establish the accuracy of the Real-Time PCR for BCR-ABL assay, to standardize the assay and to correctly evaluate the molecular response during CML patients follow up.

Each solution is obtained by diluting a known quantity of RNA from a positive cell line positive for the t(9;22) translocation (BCR-ABL rearrangement p210-b3a2) with total RNA form a normal cell line. Based on the results obtained with this product, the conversion factor can be calculated. Once the conversion factor is assigned by a reference center, the laboratory can use the Philadelphia p210 RNA reference as a tool to follow up the reliability of the conversion factor.

The product is composed of 4 different concentrations of total RNA package in color codes vials.

Catalogue Number(s)

SPG07-210
Product Description: Philadelphia p210 RNA reference
Number of Tests: 6

CE-IVD marked