{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "MycoTOOL Mycoplasma Detection Amplification Kit", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "MycoTOOL Mycoplasma Detection Amplification Kit", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.5.3.19.3.4", "ProductNameAddition": "", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_05184240001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Cell & Gene Therapy", "NodeID": "02-0133" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeName": "MycoTOOL", "NodeID": "600" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "Organization", "NodeName": "CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Quality Control Testing", "NodeID": "02-0131" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Mycoplasma Testing", "NodeID": "02-0002" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeName": "Mycoplasma Testing", "NodeID": "14-00-00" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeName": "Assays Reagents and Strips", "NodeID": "20-000-00" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeName": "Manufacturing", "NodeID": "180-00" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeName": "NOT APPLICABLE", "NodeID": "999-00" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeName": "NOT APPLICABLE", "NodeID": "99-00-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "Biologics", "NodeID": "02-0008" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "05184240001", "MaterialDescription": "MycoTOOL, Mycoplasma Detection Amp kit", "RegisteredProductName": "MycoTOOL Mycoplasma Detection Amplification Kit", "GTIN": "04038377025773", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "1 kit", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "

Vial / bottle	Cap	Label	Content
1a	red	RM1a	5 vials, 45 μl each
1b	brown	RM1b	5 vials, 570 μl each
2	grey	MgCl2 Solution	5 vials, 1 ml each
3	blue	Primer Mix, Mycoplasma	5 vials, 40 μl each
4	violet	Primer Mix, GAPDH	5 vials, 30 μl each
5	yellow	Detection Dye	5 vials, 120 μl each
6	turquoise	Water, PCR Grade	5 vials, 1 ml each
7	white	Dilution Buffer	5 vials, 1 ml each
8	white	Negative Control	5 vials, 1 ml each
9	green	Positive Control	5 vials, 55 μl each
10	orange	DNA Molecular Weight Marker	1 vial, 200 μl

", "Name": "Content" }, { "Language": "en", "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": "en", "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": "en", "Value": "Testing of cell culture samples for the absence of mycoplasma.", "Name": "Positioning" }, { "Language": "en", "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": "en", "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" } ] } } ] }