{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Glutamate V2 Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Glutamate V2 Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.19", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07395582001_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 Analyzer Products", "NodeID": "02-0009" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Family", "NodeName": "Cedex", "NodeID": "490" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeName": "CustomBiotech", "NodeID": "520" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07395582001", "MaterialDescription": "Glutamate V2 Bio", "RegisteredProductName": "Glutamate V2 Bio", "GTIN": "07613336131763", "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": "3.8.10.1.2.18", "BrandName": "Control A Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.15", "BrandName": "Calibrator A Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.16", "BrandName": "Control A Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.17", "BrandName": "Control A Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Keep at +2 to +10°C for on board use. After first use on the instrument, the reagent is stable for up to 4 weeks on board.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Measuring Range
Glutamate concentration can be determined in the following ranges.

• GLU2B: 0.015 - 1.50 g/L (0.1 - 10 mmol/L)
• GLU2D: 0.15 - 15.0 g/L (1.0 - 100 mmol/L),up to 150 g/L (1 mol/L) with postdilution

 
Conversion Factors
Conversion factors for analyte concentration:

• 1 g/L = 6.797 mmol/L
• 1 mmol/L = 147.1 mg/L

Traceability
This method has been standardized against Glutamate net weight.
 
Precision
Representative performance data on the Cedex Bio Analyzer 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		Level 2	Level 3
Mean	0.60mmol/L       (88.3 mg/L)		3.51 mmol/L        (516.3 mg/L)	6.99 mmol/L     (1 028 mg/L)
CV in-run	0.8%		0.8%	2.6%
CV inter-run	1.2%		2.2%	2.2%

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "

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

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

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Applications GLU2B (812), GLU2D (813)

GLU2B is the standard protocol for glutamate determination. If the glutamate concentration of a sample is expected to be higher than 1.2 g/L (8.2 mmol/L), then protocol GLU2D should be used (same protocol with pre-set 1:10 sample predilution).
Results higher than the valid measuring range will be flagged, and a rerun with an automatic 1:10 predilution will be recommended by the software.

Cedex Bio test definition:
Measuring mode            Absorbance
Abs. calculation mode   Endpoint
Reaction direction          Increase
Wavelength A/B               552/340 nm
Calc. first/last                   7/40
Unit                                    mmol/L, mg/L
Reaction mode               R1-S

Pipetting parameters:
R1                              200 μl
Sample                          2 μl
Total volume              202 μl
 
Calibration:
Calibrator                      Calibrator A Bio (CAL A, 599)
Calibration mode         Linear regression
Calibration interval      56 days, and if recalibration is required due to QC results 
 
Quality control:
Control A Level 1 Bio (CONA1, 111)
Control A Level 2 Bio (CONA2, 112)
Control A Level 3 Bio (CONA3, 113)
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 into the defined limits, corrective measures and recalibration are required", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "This product is intended for quantitative determination of glutamate in aqueous solutions using the Cedex Bio Instrument.", "Name": "Product Description" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 GLU2B R1	white	4 vials, 50 tests each	Reagent 1 (R1): Glutamate oxidase, 50 U/L; peroxidase, 2 kU/L; 4-aminoantipyrine, 0.3 mmol/L; TOOS, 2 mmol/L; preservative; HEPES buffer, pH 7.0.

", "Name": "Content" }, { "Language": "en", "Value": "Glutamate is a nutrient and a metabolyte in cell cultures. For optimal cell growth and product formation the glutamate concentration should be kept whithin an appropriate concentration range. For control of culture media and for monitoring in a culture process, the glutamate 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 glutamate oxidase.
Recovery: ±15%", "Name": "Specification" } ] } } ] }