SAFENSURE™ Mycoplasma Rapid Detection Kit (qPCR)

优势与特点（FAB）

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 closely related non-mycoplasma strains
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 GMP-like facility and alignment with the ISO 13485 standard

产品概述（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.

产品特性（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 closely related non-mycoplasma strains
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 GMP-like facility and alignment with the ISO 13485 standard
7. If you need the third-party verification report (Eurofins), please feel free to contact us.

应用说明（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.

技术参数（Technical Specifications）

组分（Materials Provided）

质量管理控制体系（QMS）

1. 质量管理体系（ISO, GMP）
2. 质量优势
3. 质控流程