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• Mycoplasma cell culture contamination occurs from individuals or contaminated cell culture medium ingredients.
• Mycoplasma induce cellular changes, including chromosome aberrations, changes in metabolism and cell growth.
• Severe mycoplasma infections can destroy a cell line.

The MycoTOOL Mycoplasma Real-Time PCR Kit uses specific PCR of highly conserved regions within mycoplasma DNA. Highly specific primers and probes are included in the detection mix.

• Probes are labeled with a fluorescent dye detected by real-time PCR instruments.
• Primers are a mixture that principally allows the detection of more than 150 Mollicutes species, such as A. laidlawii, M. fermentans, M. hyorhinis,M. orale, M. pneumoniae, M. synoviae, M. arginini, M. hominis, M. salivarium, and M. gallisepticum.

The kit uses a ready-to-use hot start reaction mix for detecting DNA targets with hydrolysis probes.

• The chemically modified polymerase enzyme is inactive during initial PCR setup, thereby avoiding nonspecific elongation of primer template hybrids forming at lower temperatures.
• The polymerase is irreversibly activated by an initial activation step at higher temperature.

To exclude false-negative results, controls are included.

• Reagents are controlled by a positive control and consists of a plasmid DNA (Positive Control).
• In addition, amplification of a second control plasmid (Recovery Control) added to the sample material, controls the efficiency of sample preparation, preventing false-negative results.

", "Country": "XG", "Code": "Principle", "Name": "Principle" }, { "Language": "en", "Value": "

Vial / bottle	Cap	Label	Function / description	Content
1	blue	Recovery Control	Plasmid	1 vial, 400 μl
2	red	PCR Master, 2x conc.	Contains all reagents needed for running real-time DNA detection assays except primer and template.	5 vials, 1 ml each
3	orange	UNG	Enzyme that digests dUTP-containing DNA.	1 vial, 180 μl
4	turquoise	PCR Enhancer	PCR additive	1 vial, 180 μl
5	green	Detection Mix, 25x conc.	Primers and FAM-labeled detection probe.	1 vial, 220 μl
6	yellow	Detection Mix Recovery Control, 25x conc.	Primers and LightCycler® Yellow 555-labeled detection probe.	1 vial, 140 μl
7	purple	Positive Control	Plasmid	1 vial, 800 μl
8	white	Water, PCR Grade	For PCR setup and preparation of master mix.	2 vials, 1 ml each

", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "Each lot of this kit is function tested using the MagNA Pure 96 DNA and Viral NA Large Volume Kit with the MagNA Pure 96 and LightCycler^® 480 Instrument II, using A. laidlawii at 3 and 10 cfu/ml in a 1 ml CHO cell culture with 5 × 10⁶ cells/ml. In addition, the kit is tested for the absence of mycoplasmas.", "Country": "XG", "Code": "Quality Control", "Name": "Quality Control" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "For the testing of cell culture samples for the absence of mycoplasma.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "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. ", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "Language": "en", "Value": "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)", "Country": "XG", "Code": "Benefits", "Name": "Benefits" }, { "Language": "en", "Value": "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.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "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.", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "Each lot of this kit is function tested using the MagNA Pure 96 DNA and Viral NA Large Volume Kit (Cat. No. 06 374 891 001) with the MagNA Pure 96 and LightCycler^® 480 Instrument II, using A. laidlawii at 3 and 10 cfu/mL in a 1 mL CHO cell culture with 5 × 10⁶ cells/mL. In addition the kit is tested for the absence of mycoplasmas.", "Country": "XG", "Code": "Properties", "Name": "Properties" } ] } } ] }