{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Sucrose Bio HT", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Sucrose Bio HT", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.3.4.21", "ProductNameAddition": "Test kit for the Cedex Bio HT Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07705565001_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": "07705565001", "MaterialDescription": "Sucrose Bio HT", "RegisteredProductName": "Sucrose Bio HT", "GTIN": "07613336101278", "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": "3.8.10.1.2.31", "BrandName": "Control D Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.30", "BrandName": "Control D Level 2 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": "3.8.10.1.2.29", "BrandName": "Control D Level 1 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. After first use on the instrument, the reagent is stable for up to 12 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "

Vial	Content	Composition
SUCB	Reagent cassette, 200 tests	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.
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": "en", "Value": "Applications
SUCB (995), SUCD (707), SUGLB (022), SUGLD (153)



Test Protocol
Cedex Bio HT test definition:
Measuring mode\t\t\t\t\t\t  Absorbance
Abs. calculation mode\t\t\t\t Endpoint
Reaction direction\t\t\t\t\t\tIncrease
Wavelength A/B\t\t\t\t\t\t\t340/652 nm
Calc. first/last\t\t\t\t\t\t\t\t39/69
Unit\t\t\t\t\t\t\t\t\t\t\t\t mmol/L
Reaction mode\t\t\t\t\t\t\tR1-S-SR

Pipetting parameters:
R\t\t\t\t\t\t\t\t\t\t\t\t\t 128 μL + 125 μL Diluent (H2O)
Sample\t\t\t\t\t\t\t\t\t\t\t  2 μL + 16 μL Diluent (H2O)
SR\t\t\t\t\t\t\t\t\t\t\t\t\t10 μL + 20 μL Diluent (H2O)
Total volume\t\t\t\t\t\t\t\t201 μL

Calibration:
Calibrator                                 Calibrator A Bio (CALA,07-1100-4)
Calibration mode\t\t\t\t\t  Linear regression
Calibration interval                    Each lot, 84 days, and if recalibration is required due to QC results

Quality control:
Control D Level 1 Bio (COND1, 07-1143-8)
Control D Level 2 Bio (COND2, 07-1144-6)
Control D Level 3 Bio (COND3, 07-1145-4)
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

Correction of glucose background using test setting SUGLB:

Based on the test principle, the result of the sucrose tests SUCB and SUCD (higher range due to predilution) are the sum of the sucrose and glucose concentration 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 SUCLB and SUCLD can be used. The SUCLB and SUCLD test settings run the two tests Sucrose Bio HT and Glucose Bio HT in parallel, and automatically subtracts the glucose value from the total value in order to determine the corrected sucrose concentration as the result.
In 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.Loading the test SUGLB from the Test Application Software and using the test (for correction of glucose background)

The SUGLB test setting analyzes the tests Sucrose Bio HT and Glucose Bio HT in parallel, and automatically sub-tracts the glucose value from the total value in order to determine the corrected sucrose concentration as the result.
The SUGLB test setting can be loaded into the Cedex Bio HT Analyzer database from the appropriate Test Application Software (TAS) file via the Calculated Results dialog box in the Configuration menu. Please refer to the \"Cedex Bio HT Test Application Software Installation Guide\" for more information about accessing and installing tests from TAS files, located at:
http://custombiotech.roche.com/home/Product_Details/3_8_10_3_1_1.html

Please note that the SUGLB test is automatically performed when both the Sucrose Bio HT (SUCB) and the Glucose Bio HT (GLC3B) are selected as tests for a particular sample. The SUGLB test cannot be individually selected in the Sample tab of the Orders menu.  Therefore, if the SUGLB test will be frequently performed, it may be most convenient to create a test profile that combines the SUCB and GLC3B tests.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Measuring Range
Sucrose concentration can be determined in following ranges:

• SUCB: 0.1 - 14.0 g/L (0.29 - 40.9 mmol/L)
• SUCD: 1 - 140 g/L (2.9 - 409 mmol/L),

up to maximal solubility with automatic dilution

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 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	Level 2	Level 3
Mean	2.3 mmol/L (0.787 g/L)\t\t\t	16.4 mmol/L (5.614 g/L)\t\t\t	27.8 mmol/L (9.516 g/L)
CV in-run	0.4 %	0.3 %	0.3 %
CV inter-run\t\t	0.5 %	0.3 %	0.3 %

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Kit for determination of sucrose.", "Name": "Product Description" }, { "Language": "en", "Value": "

• Cedex Bio HT 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 HT* (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": "en", "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": "en", "Value": "Method: Enzymatic photometric assay using hydrolysis by invertase and phosphorylation of glucose by hexokinase.
Recovery: ±15%", "Name": "Specification" } ] } } ] }