Vericheck ddPCR Mycoplasma Detection Kit

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Overview

The probe-based Vericheck ddPCR Mycoplasma detection Kit brings confidence in testing for mycoplasma contamination. The specificity and reproducibility of this kit allows for a precise measurement of 112 mycoplasma species using droplet digital PCR.

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Description

Description

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Mycoplasma is a commonly found contaminant in biopharmaceutical development processes that are typically not detectable by standard microscopic methods due their small size.The European, U.S., and Japanese pharmacopoeias define the levels of mycoplasma that should be present in any given product. Bio-Rad’s Vericheck ddPCR Mycoplasma Detection Kit is the first droplet digital PCR based mycoplasma testing solution. The sensitive, probe-based kit with high specificity has been designed and validated to meet European, U.S., and Japanese pharmacopoeia requirements and can detect up to 112 mycoplasma species. The QX Manager software includes tools to help with FDA 21 CFR Part 11 compliance along with a new positive control-based auto-thresholding feature that has been added for turnkey, easy data analysis.

Features and Benefits

  • Probe based test
    • Multiplex probe-based assay kit designed and Validated to meet requirements from European Pharmacopoeia (EP), U.S Pharmacopoeia (USP) and Japanese Pharmacopoeia (JP)
  • High sensitivity and specificity
    • LoD studies determine the lowest detectable concentration of mycoplasma (<6 Genome Copies/Well OR 1 CFU/ml)
    • Low cross reactivity with the related species, providing low false-positive results
  • Auto thresholding with Regulatory Compliant Software
    • Auto gate your results based on a positive control, removing manual intervention/manual data interpretation and streamlining data analysis.
    • Audit trails with tracked protocol changes for regulatory requirements

Applications and Uses

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

Required Consumables

Component Catalog#
ddPCR Pierceable Foil Seals 1814040
ddPCR 96 Well Plates 12001925
DG32 AutoDG Cartridges w/ Gaskets 1864108
1864109
Pipet Tips for AutoDG (Racks) 1864120
1864121
Waste Bins for AutoDG 1864125
AutoDG Oil for Probes 1864110
DG8 Cartridges 1864008
1864007
DG8 Gaskets 1864009
1864007
DG Oil for Probes 1863005
Droplet Reader Oil Pack 1863004
ddPCR Buffer Control for Probes 1863052
GCR96 Cartridges 12006859
QX ONE Droplet Generation Oil for Probes 12006058
QX ONE Droplet Reader Oil 12006057
GCR96 Foil Heat Seal 12006843
QX ONE ddPCR System Waste Bottle 12006060

Instruments and Software

(Bundles or different component sets) Catalog#
QX ONE Droplet Digital PCR System 12006536
QX200 AutoDG Droplet Digital PCR System consisting of:
  • QX200 Droplet Reader
  • Automated Droplet Generator
1864100
1864003
1864101
QuantaSoft 1.7 QuantaSoft Analysis Pro 1.0 1864108
1864109
QX Manager Software, Regulatory Edition 12012172
QX Manager Software, Standard Edition 12012171

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12013126
100 x 20 μl reactions, includes assay, supermix, positive control, negative control, and internal control

Documents

Documents

Number Description Options
10000130316
Vericheck ddPCR Mycoplasma Detection Kit, User Guide
7415
Vericheck ddPCR Mycoplasma Detection Kit Flyer
7427
Transitioning from Quantitative PCR to Droplet Digital PCR for Mycoplasma Detection_Application Note