{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "Glucose Bio", "DisclaimerGroup1": "", "ControlTissue": [ "" ], "BrandName": "Glucose Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.1", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "Value": "Keep at +2 to +10°C for on-board use.
\nOn-board stability: After first use on the Analyzer, the reagents are stable for up to 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "English", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "English", "Value": "

Vial	Cap	Content	Composition
1 GLC2B R1	white	2 vials, 100 tests each	Reagent 1 (R1): TRIS, 100 mmol/L; Mg2+, 4 mmol/L; adenosine triphosphate, ≥1.7 mmol/L; NADP, ≥1 mmol/L; preservative; pH 7.8.
2 GLC2B SR	black	2 vials, 100 tests each	Start Reagent (SR): HEPES, 30 mmol/L; Mg2+, 4 mmol/L; hexokinase (HK) (yeast), ≥130 μkat/L; G-6-PDH (E. coli), ≥250 μkat/L; preservative; pH 7.0.

", "Name": "Content" }, { "Language": "English", "Value": "This product is intended for quantitative determination of glucose in aqueous solutions using the Cedex Bio Analzyer.", "Name": "Product Description" }, { "Language": "English", "Value": "Glucose is an important source of carbon and energy in cell cultures and microbial fermentation. For control of culture media and for monitoring in a running culture process, the glucose concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "English", "Value": "Glucose concentrations can be determined in the ranges shown in the table below, depending on the selected test protocol.

Test definition	GLC2L (090)	GLC2B (932)	GLC2D (901)
Measuring range	Low range 2 – 750 mg/L (0.011 – 4.16 mmol/L)	High range 20 – 7,500 mg/L (0.111 – 41.6 mmol/L)	High + dilution 200 – 75,000 mg/L(1) (1.11 – 416 mmol/L)
Sample predilution	No	No	1:10
Measuring mode	Absorbance	Absorbance	Absorbance
Abs. calc. mode	Endpoint	Endpoint	Endpoint
Reaction mode	R1-S-SR	R1-S-SR	R1-S-SR
Reaction direction	Increase	Increase	Increase
Wavelength A/B	340/409 nm	340/409 nm	340/409 nm
Calc. first/last	16/37	16/37	16/37
Displayed unit	mg/L, mmol/L	mg/L, mmol/L	mg/L, mmol/L

1. Up to maximal solubility with automatic dilution.

Pipetting parameters	GLC2L (090)	GLC2B (932)	GLC2D (901)
Water Diluent (Sample Predilution)(1)	No	No	20 μL sample + 180 μL water
R1	150 µL	150 µL	150 µL
Sample (S)	20 μL + 2 μL water	2 μL + 20 μL water	2 μL + 20 μL water
SR	30 µL	30 µL	30 µL
Total Volume	202 µL	202 µL	202 µL

1. Sample predilution is performed in a prior step, after which the reaction mix is prepared in the same way as the unmodified sample.

Calibration
Calibrator	Calibrator A Bio (CAL A, 599)
Calibration mode	Linear regression
Calibration interval	Each new lot, and if recalibration is required due to QC results.

Glucose low range, GLC2L (ACN 090) v01Glucose, GLC2B (ACN 932) v02Glucose with 1:10 predilution, GLC2D (ACN 901) v03", "Name": "Protocols" }, { "Language": "English", "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": "English", "Value": "Glucose is phosphorylated by ATP in the presence of hexokinase (HK) to glucose-6-phosphate (G-6-P), which is oxidized by NADH in the presence of glucose-6-phosphate dehydrogenase (G-6-PDH). The rate of NADPH formation is measured UV-photometrically and is directly proportional to the glucose concentration.", "Name": "Principle" }, { "Language": "English", "Value": "Additional information about the calibration of the GLC2D protocol (dilution protocol)
\n
\nBoth the GLC2B and GLC2D protocols are calibrated via a 2-point linear regression curve. However, in the case of the GLC2D protocol, the calibrator is first diluted 1:10 to create the first standard. The second standard is water. In general, when the system performs an automatic dilution step to create a standard, the system only requires information about the lot-specific concentration of the analyte, provided in the Instructions for Use for the relevant calibrator. Therefore, the system will not ask for information about a second standard in the case of the GLC2D protocol.", "Name": "Protocols - Help Corner" }, { "Language": "English", "Value": "Method: Enzymatic photometric assay using hexokinase.
Recovery: ±10%", "Name": "CB - Specification" }, { "Language": "English", "Value": "Measuring Range
Glucose concentration can be determined in following ranges:

• GLC2L: 2 - 750 mg/L (0.011 - 4.16 mmol/L)
• GLC2B: 20 - 7,500 mg/L (0.111 - 41.6 mmol/L)
• GLC2D: 200 - 75,000 mg/L (1.11 - 416 mmol/L)

up to maximal solubility with automatic postdilution

Conversion Factors
Conversion factors for analyte concentration:

• 1 mmol/L = 180.2 mg/L
• 1 g/L = 5.550 mmol/L

Traceability
This method has been standardized against Isotope dilution mass spectrometry (ID-MS).

Precision
Representative performance data on Cedex Bio 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	Level 2	Level 3
Mean	2.52 mmol/L (0.454 g/L)	9.89 mmol/L (1.78 g/L)	14.1 mmol/L (2.54 g/L)
CV in-run	1.1%	0.8%	0.5%
CV inter-run	0.5%	0.6%	0.5%

", "Name": "Background Information - Help Corner" }, { "Language": "English", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "English", "Value": "Method: Enzymatic photometric assay using hexokinase.
Recovery: ±10%", "Name": "Specification" } ] } }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "StructureSystemID": null, "NodeID": "520" }, { "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": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio Analyzer Products", "StructureSystemID": null, "NodeID": "02-0009" }, { "StructureSystemName": "OWP Family", "NodeName": "Cedex", "StructureSystemID": null, "NodeID": "490" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "06343732001", "MaterialDescription": "Glucose Cedex Bio", "RegisteredProductName": "", "GTIN": "07613336133422", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "", "MaterialAnnotation": "CustomBiotech product. Please contact your local representative.", "ReadyForUse": "true", "OrderInformation": "Unit of measure is \"piece\". Will be supplied as \"Glucose Cedex Bio\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.16", "BrandName": "Control A Level 1 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.18", "BrandName": "Control A Level 3 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.17", "BrandName": "Control A Level 2 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.15", "BrandName": "Calibrator A Bio", "ProductNameAddition": "Calibrator reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] } }