Vericheck QX700™ ddPCR™ Mycoplasma Detection Kit #12025924

Mycoplasma is a common contaminant in biopharmaceutical development processes and is typically undetectable by standard microscopic because of its small size. The European, U.S., and Japanese pharmacopoeias define acceptable mycoplasma levels in biological products. The Bio-Rad Vericheck QX700 ddPCR Mycoplasma Detection Kit* is Droplet Digital PCR–based solution designed to meet European Pharmacopoeia (EP), U.S. Pharmacopeia (USP), and Japanese Pharmacopoeia (JP) requirements. Use 21 CFR Part 11–compliant software for streamlined, regulatory-compliant data analysis.

Features & Benefits

Probe based test

• Multiplex probe-based assay kit designed and validated to meet European Pharmacopoeia (EP), U.S Pharmacopoeia (USP), and Japanese Pharmacopoeia (JP) requirements

High sensitivity and specific

• LoD studies determine the lowest detectable concentration of mycoplasma
• Low cross-reactivity with the related species helps minimize false-positive results

Auto thresholding with regulatory-compliant software

• 21 CFR Part 11–compatible QX Insights Software provides audit trails with tracked protocol changes to support regulatory requirements

Applications & Uses

• Detect the presence or absence of mycoplasma in drug products
• Generate quantitative data analysis to support mycoplasma contamination assessment

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

Equipment

This kit supermix requires the use of one of the following instruments:

• QX700™ E Droplet Digital PCR System
• QX700™ S Droplet Digital PCR System
• QX700™HT Droplet Digital PCR System