{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Glutamine V2 Bio HT", "DisclaimerGroup1": null, "ControlTissue": [ "" ], "BrandName": "Glutamine V2 Bio HT", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "ID": "3.8.10.3.4.18", "ProductNameAddition": "Test kit for the Cedex Bio HT Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07395612001_im_en.png", "ImageType": "Image main" }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemIdentifier": "OWP_Product_Solutions", "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "OWP Product Types", "NodeName": "Assays Reagents and Strips", "NodeID": "20-000-00" }, { "StructureSystemIdentifier": "OWP_Organization", "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "NodeID": "01-01-01-07-00" }, { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio HT Analyzer Products", "NodeID": "02-0010" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Family", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07395612001", "MaterialDescription": "Glutamine V2 Bio HT", "RegisteredProductName": "Glutamine V2 Bio HT", "GTIN": "07613336131800", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.21", "BrandName": "Control B Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.20", "BrandName": "Control B Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.22", "BrandName": "Control B Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.19", "BrandName": "Calibrator B Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store the reagent cassette at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Keep at +2 to +15°C for on-board use. On-board stability: After first use on the analyzer, the reagents are stable for up to 12 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "This product is intended for quantitative determination of glutamine in aqueous solutions using the Cedex Bio HT Analyzer.", "Name": "Product Description" }, { "Language": "en", "Value": "

Vial	Content	Composition
GLN2B	Reagent cassette, 200 tests	Reagent 1 (R1): Glutamate oxidase, 200 U/L; catalase, 600 kU/L; 4-aminoantipyrine, 0.4 mmol/L; TOOS, 2 mmol/L; preservative; HEPES buffer, pH 7.0.
Start Reagent (SR): Glutaminase, 2.5 kU/L; peroxidase, 8.6 kU/L; TOOS, 2 mmol/L; preservative; HEPES buffer, pH 7.0.

", "Name": "Content" }, { "Language": "en", "Value": "Measuring Range
Glutamine concentration can be determined in following ranges:

• GLN2B: 15 - 1.500 mg/L (0.1 - 10 mmol/L)
• GLN2D: 75 - 7.500 mg/L (0.5 - 50 mmol/L),

up to maximal solubility with automatic dilution

Conversion Factors
Conversion factors for glutamine concentration:

• 1 g/L = 6.842 mmol/L
• 1 mmol/L = 146.2 mg/L

Traceability
This method has been standardized against glutamine net weight.

Precision
Representative performance data on Cedex Bio HT Analyzers are shown. Results obtained in individual laboratories may differ.
Precision was determined in samples of three concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 10 days).

	Level 1	\t  Level 2	Level 3
Mean	1.74 mmol/L (253.8 mg/L)	\t 3.89 mmol/L\t  \t (569.2 mg/L)	8.44 mmol/L (1233.7 mg/L)
CV in-run	1.8%	\t  1.8%	1.2%
CV inter-run	2.3%	\t  2.7%	1.9%

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "

• Cedex Bio HT Analyzer*, including accessories and disposables
• Standard laboratory equipment

• Calibrator B Bio*
• Control B Level 1 Bio*
• Control B Level 2 Bio*
• Control B Level 3 Bio*

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Application GLN2B (737), GLN2D (674)

Cedex Bio HT test definition:
Measuring mode\t\t\t\t\t\tAbsorbance
Abs. calculation mode\t\t\t   Endpoint
Reaction direction\t\t\t\t\t  Increase
Wavelength\t\t\t\t\t\t\t\t  552 nm
Calc. first/last\t\t\t\t\t\t\t  82/114
Unit\t\t\t\t\t\t\t\t\t\t\t   mmol/L, mg/L
Reaction mode\t\t\t\t\t\t   R1-S-SR

Pipetting parameters:
R1\t\t\t\t\t\t\t\t\t\t\t\t 140 μL
Sample\t\t\t\t\t\t\t\t\t\t\t2 μL
SR\t\t\t\t\t\t\t\t\t\t\t\t  42 μL
Total volume\t\t\t\t\t\t\t  184 μL

Calibration:
Calibrator                                  Calibrator B Bio (CAL B, 07-1105-5)
Calibration mode\t\t\t\t\t  Linear regression
Calibration interval\t\t\t\t   84 days, and if recalibration is required due to QC results

Quality control:
Control B Level 1 Bio (CONB1, 07-1106-3)
Control B Level 2 Bio (CONB2, 07-1107-1)
Control B Level 3 Bio (CONB3, 07-1109-8)
Use the recommended control material. Other suitable control material can be used in addition.
Control intervals and acceptance limits should be adapted to each laboratory's individual requirements.
If values do not fall within the defined limits, corrective measures and recalibration are required", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Glutamine is an essential nutrient required in cell cultures and microbial fermentation. For optimal cell growth and product formation the glutamine concentration has to be kept whithin an appropriate concentration range, providing sufficient nutrition and avoiding toxical accumulation of ammonia by degradation of an excess of glutamine. Due to the spontaneous degradation, additional glutamine should be added during the cultivation, according to the actual consumption. For control of culture media and for monitoring in a culture process, the glutamine concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Enzymatic photometric assay using glutaminase.
Recovery: ±15%", "Name": "Specification" }, { "Language": "en", "Value": "

• Handle all samples as if potentially infectious, using safe laboratory procedures. As the sensitivity and titer of potential pathogens in the sample material can vary, the operator must optimize pathogen inactivation and follow the appropriate measures according to local safety regulations.
• Do not eat, drink, or smoke in the laboratory work area.
• Do not pipette by mouth.
• Wear protective disposable gloves, laboratory coats, and eye protection, when handling samples and kit reagents.
• Wash hands thoroughly after handling samples and reagents.

• Discard unused reagents and waste in accordance with country, federal, state, and local regulations.
• Safety Data Sheets (SDS) are available online at documentation.roche.com, or upon request from the local Roche office.

", "Name": "Safety Information" } ] } } ] }