Performance Evaluation of a Rapid Fully Automated Mycoplasma Detection System

October 21, 2021

The BIOFIRE® Mycoplasma Panel is a closed and fully automated “lab in a pouch” system that provides highly sensitive and broad detection of Mollicutes with less than five minutes of hands-on time. The disposable reagent pouch integrates nucleic acid purification and nested multiplex real-time PCR with less than one hour of run time and requires minimal training and skill to operate.

Designed to meet compendial testing standards, Limit of Detection (LoD) studies have been performed with a particular focus on species listed by the United States, European, and Japanese pharmacopeias using 0.2 mL and 10 mL sample volumes. The LoD for 10 mL samples is ≤ 10 CFU/mL for all mycoplasmas tested and only requires a few simple pre-processing steps by centrifugation. Direct testing of 0.2 mL samples provides detection of ≤ 33 CFU/mL and is intended to facilitate more frequent surveillance of raw materials, cell banks, early product intermediates, and biologics with limited volume availability such as cell therapies.