For use in quality control/manufacturing process only. Others MycoTOOL Mycoplasma Real-Time PCR Kit MycoTOOL Mycoplasma Real-Time PCR Kit 3.5.3.19.3.2 06495605001 MycoTOOL Mycoplasma Real-Time PCR Kit MycoTOOL Mycoplasma Real-Time PCR Kit 07613336132692 Reagents, kits 1 kit 160 PCRs each with a 50 µl final reaction volume CustomBiotech product. Please contact your local representative. Unit of measure is "piece". Mycoplasma are severe contaminants in cell culture.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. en For the testing of cell culture samples for the absence of mycoplasma. en 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.  en Achieve high sensitivity and specificity through improved tests • ≤10 CFU/ml, meeting regulatory requirements • No cross reactivity with closely related bacterial speciesRely 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) en 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. en 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, such as the European Directorate for the Quality of Medicines & Health Care. en