{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "Sucrose Bio", "DisclaimerGroup1": "", "ControlTissue": [ "" ], "BrandName": "Sucrose Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.21", "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. After first use on the analyzer, the reagent is 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": "

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

• Calibrator A Bio*
• Control D Level 1 Bio*
• Control D Level 2 Bio*
• Control D Level 3 Bio*
• Glucose Bio (only for correction of glucose background)
• Control A Level 1 Bio* (only for correction of glucose background)
• Control A Level 2 Bio* (only for correction of glucose background)
• Control A Level 3 Bio* (only for correction of glucose background)

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "English", "Value": "Method: Enzymatic photometric assay using hydrolysis by invertase and phosphorylation of glucose by hexokinase.
Recovery: ±15%", "Name": "CB - Specification" }, { "Language": "English", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "English", "Value": "Kit for determination of sucrose", "Name": "Product Description" }, { "Language": "English", "Value": "Sucrose is hydrolyzed to glucose and fructose by β-fructosidase. Glucose is phosphorylated by ATP in the presence of hexokinase (HK) to glucose-6-phosphate (G-6-P), which is oxidized by NADP+ in the presence of glucose-6-phosphate dehydrogenase (G6PDH). The rate of NADPH formation is measured UV-photometrically and is directly proportional to the sucrose concentration.", "Name": "Principle" }, { "Language": "English", "Value": "Measuring Range
Sucrose concentration can be determined in following range:

• SUCB: 0.1 - 14 g/L (0.29 - 40.9 mmol/L)
• SUCD: 1 - 140 g/L (2.9 - 409 mmol/L), up to maximal solubility with automatic postdilution

Conversion Factors
Conversion factors for sucrose concentration:

• 1 mmol/L = 342.3 mg/L
• 1 g/L = 2.921 mmol/L

Traceability
This method has been standardized against sucrose net weight.

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	2.3 mmol/L (0.787 g/L)	16.4 mmol/L (5.614 g/L)	27.8 mmol/L (9.516 g/L)
CV in-run	0.9%	0.9%	1.0%
CV inter-run	1.0%	0.5%	0.6%

", "Name": "Background Information - Help Corner" }, { "Language": "English", "Value": "Applications
\nSUCB (021), SUCD (022), SUGLB (910), SUGLD (930)
\n \n\n
\nTest Protocol
\nCedex Bio test definition:
\nMeasuring mode                         Absorbance
\nAbs. calculation mode                Endpoint
\nReaction direction                       Increase
\nWavelength A/B                            340/409 nm
\nCalc. first/last                               16/37
\nUnit                                                 mmol/L
\nReaction mode                            R1-S-SR
\n
\nPipetting parameters:
\nR                                                128 μL + 125 μL Diluent (H2O)
\nSample                                         2 μL + 16 μL Diluent (H2O)
\nSR                                               10 μL + 10 μL Diluent (H2O)
\nTotal volume                              191 μL
\n
\nCalibration:
\nCalibrator                                Calibrator A Bio (CAL A, 599)
\nCalibration mode                    Linear regression
\nCalibration interval                  Each lot, 84 days, and if recalibration is required due to QC results
\n
\nQuality control:
\nControl D Level 1 Bio (COND1, 307)
\nControl D Level 2 Bio (COND2, 308)
\nControl D Level 3 Bio (COND3, 309)
\nUse the recommended control material. Other suitable control material can be used in addition.
\nControl intervals and acceptance limits should be adapted to each laboratory's individual requirements.
\nIf values do not fall within the defined limits, corrective measures and recalibration are required
\n
\nCorrection of Glucose Background using test setting SUGLB or SUGLD:
\n
\nBased on the test principle, the results of the sucrose tests SUCB and SUCD (higher range due to predilution) are the sum of the sucrose and glucose concentrations in the sample. If there is a relevant glucose background concentration in the sample, and the concentration needs to be determined for sucrose only, then the test settings SUGLB and SUGLD can be used. The SUGLB and SUGLD test settings run the tests Sucrose Bio and Glucose Bio in parallel, and automatically subtract the glucose value from the total value in order to determine the corrected sucrose concentration as the result..
\n
\nIn case of much higher glucose concentrations compared to the sucrose concentration, calculated sucrose values close to the lower limit of the measuring range may be less accurate. For example, with a glucose background of 13 mmol/L (4.5 g/L), sucrose values <2.3 mmol/L (<0.8 g/L) may have an inaccuracy >15%. For sucrose concentrations >2.3 mmol/L (>0.8 g/L) the accuracy of the result should not be affected by the glucose background.
\n
\nThe test settings SUGLB and SUGLD need to be created manually on the Cedex Bio Analyzer using the Add Ratio function; the following settings should be used:
\n \n\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n

	SUGLB	SUGLD
Code	910	930
Short Name	SUGLB
Long Name	Sucrose Glc- \n\t\t\tcorrected
Application A	SUCB
Application B	GLC2B
Application C	None	None
Application D	None	None
Coeffecient w	0	0
Coeffecient x	0	0
Coeffecient y	0	0
Coeffecient z	0	0
Formula	(A-B)	(A-B)
Factor	1	1
Offset	0	0
Laboratory Correlation	Off	Off
Valuation	No Valuation	No Valuation
Low Used	Off	Off
High Used	Off	Off
Low Limit	0	0
HighLimit	0	0
Standard Unit	mmol/L	mmol/L
Laboratory Unit	mg/L	mg/L
Result Conversion Factor	342.3	342.3
Display Unit	Laboratory Unit	Laboratory Unit
Dec. Position	2	2

\n
\nRefer to the Cedex Bio System Operator's Manual for further information about creating test settings with the Add Ratio function.
\n \n\n", "Name": "Protocols - Help Corner" }, { "Language": "English", "Value": "

Vial	Cap	Content	Composition
1 SUCB R1	white	4 vials, 50 tests each	Reagent 1 (R1): MES, 5.0 mmol/L; adenosine triphosphate, 4.5 mmol/L; Mg2+, 24 mmol/L; NADP, ≥7 mmol/L; β-fructosidase, ≥140 kU/L; pH 6.0.
2 SUCB SR	black	4 vials, 50 tests each	Start Reagent (SR): HEPES, 200 mmol/L; Mg2+, 4 mmol/L; hexokinase (HK), ≥300 μkat/L; G6PDH, ≥300 μkat/L; pH 8.0.

", "Name": "Content" }, { "Language": "English", "Value": "Sucrose can be used as source of carbon and energy in cell cultures. Use of sucrose instead of glucose in the culture medium offers the advantage of lower osmolality (based on gramm of carbohydrate). Furthermore, producing therapeutic antibodies, the use of sucrose in the cell culture affects the oligosaccharide maturation on the recombinant proteins, resulting in an increase in the percentage of high mannose N-glycan species, as well as a concomitant reduction in fucosylation, which increases the antibody-dependent cell-mediated cytotoxicity for the antibody. For control of culture media and for monitoring in a running culture process, the sucrose concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "English", "Value": "Method: Enzymatic photometric assay using hydrolysis by invertase and phosphorylation of glucose by hexokinase.
Recovery: ±15%", "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": "07705557001", "MaterialDescription": "Sucrose Bio", "RegisteredProductName": "", "GTIN": "07613336101285", "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": "3.8.10.1.2.30", "BrandName": "Control D Level 2 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.29", "BrandName": "Control D Level 1 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" }, { "ProductID": "3.8.10.1.2.31", "BrandName": "Control D Level 3 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] } }