SAFENSURE™ Mycoplasma Rapid Detection Kit (qPCR)

Product Overview

To expedite in-process and lot-release testing, the Mycoplasma rapid detection kit, based on Nucleic Acid Amplification Technology (NAT), has been developed and validated to meet the requirements outlined in European Pharmacopeia Chapter 2.6. 7.

Combined with mycoplasma DNA Sample Preparation kit (OPA-E101), this kit sensitively and reliably detects mycoplasma contamination in biological products, meeting or exceeding the regulatory guidance of 10 CFU/mL. The assay eliminates the need for time-consuming culture-based methods, simplifying the mycoplasma testing process and yielding results in 2-2.5 hours with high efficiency.

Features

1. Broad Coverage: Covers over 250 Mollicutes (Mycoplasma, Acholeplasma and Spiroplasma) species, including all mycoplasma species listed in Pharmacopoeias (EP, USP, JP)
2. Strong Specificity: Developed with multiple primers and probes targeting mycoplasma species' 16s rRNA, with no cross reactivity with common manufacturing host cells or mammalian cells
3. High Sensitivity: Fully compliant with or superior to regulatory guidance of 10 CFU/mL
4. Convenient Operation: Designed for single-well testing, with the kit containing essential components for easy use
5. Comparable Results: Detection results from the kit are comparable to those from culture-based methods
6. High-quality: This kit is manufactured in ISO 13485 standard facility.
7. If you need the third-party verification report (Eurofins), please feel free to contact us.

Application

The kit is used for detection of mycoplasma contamination in biological product, cells and bioproduct media etc.

For use in quality control/manufacturing process only.

It is for research use only.

Technical Specifications

Materials Provided

ACRO Quality Management System

1. QMS(ISO, GMP)
2. Quality Advantages
3. Quality Control Process