{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Pyruvate Bio HT", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Pyruvate Bio HT", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.3.4.16", "ProductNameAddition": "Test kit for the Cedex Bio HT Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07299818001_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": "07299818001", "MaterialDescription": "Pyruvate Bio HT", "RegisteredProductName": "Pyruvate Bio HT", "GTIN": "07613336132920", "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": "3.8.10.1.2.28", "BrandName": "Calibrator D 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" }, { "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": "3.8.10.1.2.31", "BrandName": "Control D Level 3 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 cassette is stable for up to 8 weeks on board.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "

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

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

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Kit for determination of pyruvate.", "Name": "Product Description" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Pyruvate is an important source of carbon and energy in cell cultures. It is generated as an intermediate in the glycolysis pathway by the cells using glucose. Control of the pyruvate concentration in the culture by additional feeding of pyruvate enables optimization of cell growth and product formation. For control of culture media and for monitoring in a culture process, the pyruvate concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "

Vial	Content	Composition
PYRB	Reagent cassette, 200 tests	Reagent 1 (R1): TRIS, 230 mmol/L; sodium chloride, 80 mmol/L; lactate dehydrogenase, approximately 4,000 U/L; stabilizer; preservative; pH 7.6.
Reagent 2 (R2): Sodium bicarbonate, 20 mmol/L; NADH, 3.2 mmol/L; preservative; pH 10.2.

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

• PYRB: 8.7 - 696 mg/L (0.1 - 8 mmol/L)
• PYRD: 87 - 6960 mg/L (1 - 80 mmol/L),

up to 69.6 g/L (0.8 mol/L) with automatic dilution

Conversion factors for pyruvate concentration

• 1 mmol/L = 87.06 mg/L
• 1 g/L = 11.49 mmol/L

Traceability
This method has been standardized against titration with HClO₄.

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	0.52 mmol/L\t   (45.3 mg/L)	4.0 mmol/L\t\t  (348 mg/L)	7.0 mmol/L (609 mg/L)
CV in-run	0.8 %	0.2 %	0.2 %
CV inter-run	2.1 %	1.2 %	1.2 %

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Application PYRB (799), PYRD (886)
Cedex Bio HT test definition

• Measuring mode:\t\t\tAbsorbance
• Abs. calculation mode:   Endpoint
• Reaction mode:\t\t\t   R1-R2-S
• Reaction direction:\t\t  Decrease
• Wavelength A/B:\t\t\t  340/378 nm
• Calc. first/last:\t\t\t\t  33/60
• Unit:\t\t\t\t\t\t\t\t   mmol/L, mg/L

Pipetting parameters

• R1\t\t\t\t\t\t\t\t\t   70 μL + 64 μL Diluent (H2O)
• R2\t\t\t\t\t\t\t\t\t   20 μL
• Sample\t\t\t\t\t\t\t  6 μL + 10 μL Diluent (H2O)
• Total volume\t\t\t\t\t170 μL

Calibration

• Calibrator:\t\t\t\t\t\tCalibrator D Bio (CAL D, 07-1141-1)
• Calibration mode:\t\t   Linear regression
• Calibration interval:\t\t 56 days, and if recalibration is required due to QC results

Quality Controls

• 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.

Intervals / limits: 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": "Method: Enzymatic photometric assay using lactate dehydrogenase.
Recovery: ±15%", "Name": "Specification" } ] } } ] }