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:
- QX700TM E Droplet Digital PCR System*
- QX700TM S Droplet Digital PCR System*
- QX700TM HT Droplet Digital PCR System*
*For Research Use Only. Not for use in diagnostic procedures.
Required Consumables
| Component | Catalog 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
Ordering
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
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QX700 ddPCR System Analysis SoftwareQX700-ddPCR-System-Analysis-Software
Flexible ddPCR analysis software — built to fit your workflow
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QX700 ddPCR System Control SoftwareQX700-ddPCR-System-Control-Software
Software for QX700 instrument control with intuitive plate setup
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QX700 Supermix Configurator SoftwareQX700-Supermix-Configurator-Software
QX700 Supermix Configurator V1.5