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Vericheck QX700™ ddPCR™ Mycoplasma Detection Kit

Vericheck QX700™ ddPCR™ Mycoplasma Detection Kit

The probe-based Vericheck ddPCR Mycoplasma Detection Kit brings confidence in testing for Mycoplasma contamination. The specificity and reproducibility of this kit allow for a precise measurement of Mycoplasma species using the QX700 Droplet DigitalTM PCR (ddPCR) System.*

*For Research Use Only. Not for use in diagnostic procedures.

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Overview

Mycoplasma is a commonly found contaminant in biopharmaceutical development processes, not typically detectable by standard microscopic methods due to its small size. Bio-Rad’s Vericheck ddPCRTM Mycoplasma Detection Kit is a ddPCR-based Mycoplasma testing solution. The sensitive, highly specific, probe-based kit has been designed to meet pharmacopoeia requirements for acceptable levels of Mycoplasma in any given product. Use 21 CFR Part 11–compliant software for turnkey, easy data analysis.

Features & Benefits

  • Probe-based test: multiplex probe-based assay kit designed and validated to meet requirements from European Pharmacopoeia (EP), US Pharmacopoeia (USP) and Japanese Pharmacopoeia (JP)
  • High sensitivity and specificity: LoD studies determine the lowest detectable concentration of Mycoplasma It has low cross-reactivity with related species, providing low false-positive results
  • Auto thresholding with Regulatory Compliant Software: 21 CFR Part 11 compatible QX Insights Software offers audit trails with tracked protocol changes for regulatory requirements

Applications & Uses

  • Detecting presence or absence of Mycoplasma in drug products
  • Quantitative data analysis providing confirmation on the quantity of Mycoplasma

Additional Equipment

This digital PCR supermix requires the use of one of the following instruments:

*For Research Use Only. Not for use in diagnostic procedures.

Required Consumables

ComponentCatalog Number
RDG16 Cartridges (Bio-Rad Laboratories, Inc.)12025252
Staticide SW12 Anti-Static Wipes (ACL, Inc.) 
Kimtech Science Precision Wipes (Kimberly Clark)05511
Extraction-free workflow: Droplet Digital PCR Enhancer Reagent A (Bio-Rad Laboratories, Inc.)12013425

Required Software

  • QX700TM ddPCRTM System Analysis Software
  • QX700 ddPCR System Control Software

Specifications

Storage at –20°C
Refer to expiration date

Ordering

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12025924 sku view
12025924

The probe-based Vericheck QX700 ddPCR Mycoplasma Detection Kit enables sensitive, reproducible detection of mycoplasma contamination using the QX700 Droplet Digital™ PCR (ddPCR) System.*

*For Research Use Only. Not for use in diagnostic procedures.

Downloads

  • QX700 ddPCR System Analysis Software
    QX700-ddPCR-System-Analysis-Software

    Flexible ddPCR analysis software — built to fit your workflow

  • QX700 ddPCR System Control Software
    QX700-ddPCR-System-Control-Software

    Software for QX700 instrument control with intuitive plate setup

  • QX700 Supermix Configurator Software
    QX700-Supermix-Configurator-Software

    QX700 Supermix Configurator V1.5

Documents