MycoTOOL Mycoplasma Real-Time PCR Kit
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MycoTOOL Mycoplasma Real-Time PCR Kit material number and pack size: Material Number Pack Size 06495605001 1 kit
For the testing of cell culture samples for the absence of mycoplasma.
The MycoTOOL Mycoplasma Real-Time PCR Kit is designed to test at least 10 cell culture samples for the absence of Mycoplasma. The kit contains sufficient reagents to run 160 PCRs each with a 50 μl reaction volume. Total hands-on time PCR setup: approximately 1 hour. Total time-to-result (without sample preparation): approximately 4 hours.
Achieve high sensitivity and specificity through improved tests
• ≤10 CFU/ml, meeting regulatory requirements
• No cross reactivity with closely related bacterial species
Rely on an accurate, and robust test procedure
• Measures ~150 culturable and non-culturable mycoplasma species
• Optimized controls and validated reagents (mycoplasma free)
Save time with easy-to-use kit and proven real-time PCR technology
• Automated workflow using automated sample preparation and Real-Time PCR
• <5 hours, including sample preparation (data on file)
- The MycoTOOL Mycoplasma Real-Time PCR Kit is an in vitro nucleic acid amplification test optimized for the detection of Mycoplasma in CHO cell culture, according to the Nucleic Acid Amplification Tested (NAT) guidelines for Mycoplasma described in Chapter 2.6.7 of the European Pharmacopoeia, with respect to specificity, sensitivity/detection limit, and robustness. The performance criteria of this kit when testing other cell lines, such as NS0 and SP2, need to be established by the user. The kit was developed according to the cfu specifications provided by suppliers of test materials (e.g., European Directorate for the Quality of Medicines & Health Care).
In combination with this kit, there are two options for sample preparation, manual or automated. The MycoTOOL Mycoplasma Real-Time PCR Kit is easily combined with the MagNA Pure 96 Automated Sample Preparation System and the LightCycler® 480 Real-Time PCR Instrument for high throughput automated workflows. In case of manual nucleic acid isolation the QC Sample Preparation Kit is recommended.
Sample Prep: 1 mL cell culture from high throughput or manual sample preparations
Control Concept: Recovery of sample preparation is controlled using an Internal Control
Enhanced Specificity: Over 140 mycoplasma species can be detected. The probeformat ensures that nonspecific amplicons are not detected.
All Reagents Included: Supplied and ready-to-use reagents jump start your assay
High Cell Densities: Unprocessed bulk of standard cell concentrations (e.g., 5x106 CFU/mL) processed directly.
High Quality: Standardized manufacturing according to ISO 13485. Change notification also available.
Stability: At -15 to -25°C within specification range for max. 18 months.