{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "MycoTOOL Mycoplasma Detection Amplification Kit", "DisclaimerGroup1": "", "ControlTissue": [ "" ], "BrandName": "MycoTOOL Mycoplasma Detection Amplification Kit", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.5.3.19.3.4", "ProductNameAddition": "", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "Value": "Mycoplasmas can act as severe contaminants in cell culture. Mycoplasmal cell culture contamination occurs due to contamination from individuals or contaminated cell culture medium ingredients. Mycoplasmas may induce cellular changes, including chromosome aberrations, changes in metabolism and cell growth. Severe mycoplasma infections may destroy a cell line.", "Name": "Principle" }, { "Language": "English", "Value": "

• Each lot of the MycoTOOL Mycoplasma Detection Amplification Kit is function tested for the detection of mycoplasma in CHO cell lines using 3 and 10 cfu of A. laidlawii in 1 ml CHO cell culture (5 × 10⁶ cells/ml).
• Each lot of QC Sample preparation Kit is function tested for the detection of mycoplasma with the MycoTOOL Mycoplasma Real-time PCR Kit.
• Both kits are tested for the absence of DNA from mycoplasma.

", "Name": "Quality Control" }, { "Language": "English", "Value": "Sensitive control (10 CFU/mL A. laidlawii): For at least 2/4 replicates a band at 450 bp must be recognized.
Negative control of the whole workflow (mycoplasma): For at least 5/6 replicates no band between 420 and 480 bp is recognized.
Positive control of the whole workflow (GAPDH): For each sample a band at 150 bp is recognized.
Negative control of the PCR (Mycoplasma and GAPDH): For all 4 replicates no band is recognized.
Positive control of the PCR (Mycoplasma): For 2/4 replicates a band is recognized at 360 bp.", "Name": "CB - Specification" }, { "Language": "English", "Value": "

1. Reaction Mix 1a
   Reaction Mix 1b
2. MgCl₂ -Solution
3. Primer Mix, Mycoplasma
4. Primer Mix GAPDH
5. Detection Dye
6. PCR grade Water
7. Dilution Buffer
8. Negative Control
9. Positive Control
10. DNA Molecular Weight Marker

", "Name": "Content (Catalog)" }, { "Language": "English", "Value": "Testing of cell culture samples for the absence of mycoplasma.", "Name": "Positioning" }, { "Language": "English", "Value": "The MycoTOOL Mycoplasma Detection Amplification Kit is an in vitro nucleic acid amplification test optimized for the detection of mycoplasma in CHO cell culture according to the Guideline for Mycoplasma NAT described in chapter 2.6.7 of the European Pharmacopeia with respect to specificity, sensitivity/detection limit, and robustness.

In combination with this kit, a manual sample preparation with the QC Sample Preparation Kit is recommended. A sample preparation protocol with the QC Sample Preparation Kit for cell culture sample with a density of <5 x 10⁶ cells/ml and a protocol for high cell density is available in the instructions for use (method sheet) on Roche portal eLabDoc:  documentation.roche.com", "Name": "Applications" }, { "Language": "English", "Value": "Sensitive control (10 CFU/mL A. laidlawii): For at least 2/4 replicates a band at 450 bp must be recognized.
Negative control of the whole workflow (mycoplasma): For at least 5/6 replicates no band between 420 and 480 bp is recognized.
Positive control of the whole workflow (GAPDH): For each sample a band at 150 bp is recognized.
Negative control of the PCR (Mycoplasma and GAPDH): For all 4 replicates no band is recognized.
Positive control of the PCR (Mycoplasma): For 2/4 replicates a band is recognized at 360 bp.", "Name": "Specification" } ] } }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "StructureSystemID": null, "NodeID": "520" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cell & Gene Therapy", "StructureSystemID": null, "NodeID": "02-0133" }, { "StructureSystemName": "OWP Family", "NodeName": "MycoTOOL", "StructureSystemID": null, "NodeID": "600" }, { "StructureSystemName": "OWP Product Types", "NodeName": "Assays, Reagents and Strips", "StructureSystemID": null, "NodeID": "20-000-00" }, { "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureSystemID": null, "NodeID": "01-01-01-07-00" }, { "StructureSystemName": "Applications", "NodeName": "Mycoplasma Testing", "StructureSystemID": null, "NodeID": "20-00-00" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Quality Control Testing", "StructureSystemID": null, "NodeID": "02-0131" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Mycoplasma Testing", "StructureSystemID": null, "NodeID": "02-0002" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "05184240001", "MaterialDescription": "MycoTOOL, Mycoplasma Detection Amp kit", "RegisteredProductName": "", "GTIN": "04038377025773", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 kit", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.5.3.19.3.1", "BrandName": "MycoTOOL PCR Mycoplasma Detection Prep Kit", "ProductNameAddition": "", "ReferenceType": "Reagent" } ] } }