{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Acetate V2 Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Acetate V2 Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.20", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07395442001_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": "07395442001", "MaterialDescription": "Acetate V2 Bio", "RegisteredProductName": "Acetate V2 Bio", "GTIN": "07613336130643", "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": "3.8.10.1.2.29", "BrandName": "Control D Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.28", "BrandName": "Calibrator D Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.31", "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": "3.8.10.2.3.4", "BrandName": "Chimneys", "ProductNameAddition": "Consumable for the Cedex Bio Analyzer", "ReferenceType": "Consumable" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Keep at +2 to +10°C for on board use.
On-board stability: After first use on the instrument, the reagent is stable for up to 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Applications AC2B (031), AC2D (O32)

AC2B is the standard protocol for acetate determination.
If the acetate concentration of a sample is expected to be higher than 2.3 g/L (38.9 mmol/L), then protocol AC2D should be used (same protocol with preset 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                     340/409 nm
Calc. first/last                         23/40
Unit                                          mmol/L
Reaction mode                     R1-S-SR

Pipetting parameters:
R1                                           120 μL + 5 μL Dilutent (H2O)
Sample                                      2 μL + 5 μL Dilutent (H2O)
SR                                            30 μL + 5 μL Dilutent (H2O)
Total volume                        167 μL

Calibration:
Calibrator                              Calibrator D Bio (CALD, 794)
Calibration mode                 Linear regression
Calibration interval              56 days, and if recalibration is required due to QC results

Quality control:
Controls
Control D Level 1 Bio (COND1, 307)
Control D Level 2 Bio (COND2, 308)
Control D Level 3 Bio (COND3, 309)
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

", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "This product is intended for quantitative determination of acetate in aqueous solutions using the Cedex Bio Analyzer.", "Name": "Product Description" }, { "Language": "en", "Value": "

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

• 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": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 AC2B R1	white	4 vials, 50 tests each	Reagent 1 (R1): Triethanolamine, 0.2 mol/L; L-malic acid, 2.4 g/L; magnesium chloride, 1.2 g/L; coenzyme A, 0.3 g/L; adenosine triphosphate, 3.8 g/L; nicotinamide adenine dinucleotide, 3 g/L; dithiothreitol, 0.3 g/L; preservative; pH 4.8.
2 AC2B SR	black	4 vials, 50 tests each	Start Reagent (SR): Potassium phosphate buffer, 100 mM, pH 9.0; L-malate dehydrogenase, 119 U/mL; citrate synthase, 28 U/mL; acetate kinase, 32.5 U/mL; phosphotransacetylase, 97 U/mL; stabilizer; preservative.

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

• AC2B: 15 - 2300 mg/L (0.25 - 38.8 mmol/L)
• AC2D: 1.5 - 23 g/L (2.5 - 388 mmol/L), up to 230 g/L (3.88 mol/L) with automatic predilution

Conversion Factors
Conversion factors for acetate concentration:

• 1 mmol/L = 59.05 mg/L
• 1 g/L = 16.93 mmol/L

Traceability
This method has been standardized against an independent photometric ezymatic assay.

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 calculate in-run precision (n=21) and inter-run precision (on 10 days).

	Level 1	Level 2	Level 3
Mean	2.79 mmol/L (165 mg/L)	17.83 mmol/L (1053 mg/L)	28.41 mmol/L (1678 mg/L)
CV in-run	1.04 %	3.64 %	5.58 %
CV inter-run	3.67 %	2.73 %	6.34 %

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Acetate is an important metabolyte in microbial fermentation. Accumulation of acetate can suppress culture growth and product formation. For monitoring in a culture process, acetate 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 phosphorylation by acetate kinase.
Recovery: ±15%", "Name": "Specification" } ] } } ] }