{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "NH3 Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "NH3 Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.3", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06343775001_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": "06343775001", "MaterialDescription": "NH3L Cedex Bio", "RegisteredProductName": "NH3 Bio", "GTIN": "07613336133507", "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 \"NH3L Cedex Bio\"." } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "3.8.10.1.2.22", "BrandName": "Control B Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.20", "BrandName": "Control B Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.19", "BrandName": "Calibrator B Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.21", "BrandName": "Control B Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Keep at +2 to +10°C for on-board use.
After first use on the instrument, the reagents are stable for up to 4 weeks.
", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "en", "Value": "Kit for determination of ammonia.", "Name": "Product Description" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Cedex Bio test definition:

• Measuring mode  Absorbance
• Abs. calculation mode Endpoint
• Reaction direction    Decrease
• Wavelength A/B 340/629 nm
• Calc. first/last 7/31
• Unit  mmol/L
• Reaction mode R1-R2-S

Pipetting parameters:

• R1    40 μl + 30 μl Diluent (H2O)
• R2    20 μl + 30 μl Diluent (H2O)
• Sample   2 μl + 10 μl Diluent (H2O)
• Total volume  132 μl

Calibration:

• Calibrator   Calibrator B Bio (CAL B, 541)
• Calibration mode  Linear regression
• Calibration intervall  Each new lot, and if recalibration is required due to QC results

Quality control:

• Control B Level 1 Bio (CONB1, 401)
• Control B Level 2 Bio (CONB2, 402)
• Control B Level 3 Bio (CONB3, 403)

Use the recommended control material. Other suitable control material can be used in addition.

For quality control in the low range of test protocol NH3LB, prepare an appropriate control by diluting \"Control B Level 1 Bio\" 1:5 using water as the diluent. Divide the NH3 concentration and the \"1s\" value of the original control by 5 for entering the lot-specific NH3 values.

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": "NH3 concentration can be determined in following ranges:

• NH3LB: 0.0278 - 1.389 mmol/L (0.473 - 23.66 mg/L)
• NH3B: 0.278 - 13.89 mmol/L (4.73 - 236 mg/L)
• NH3D: 5.56 - 278 mmol/L (95 - 4720 mg/L), up to 5.56 mol/L (95 g/L) with postdilution

Conversion Factors
Conversion factors for analyte concentration:

• 1 mmol/L NH₃ = 17.03 mg/L NH₃
• 1 mg/L NH₃ = 58.72 μmol/L NH₃
• 1 mmol/L NH₄⁺ = 18.04 mg/L NH₄⁺
• 1 mg/L NH₄⁺ = 55.43 μmol/L NH₄⁺

Traceability
This method has been standardized against a standard reference material (SRM 194).

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 30 days).

	Level 1	Level 2	Level 3
Mean	0.70 mmol/L (11.9 mg/L)	2.34 mmol/L (40.0 mg/L)	2.96 mmol/L (50.4 mg/L)
CV in-run	3.0%	2.9%	1.4%
CV inter-run	5.9%	3.4%	1.3%

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "

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

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

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 NH3B R1	white	2 vials, 100 tests each	Reagent 1 (R1): BICINE, 330 mmol/L; glutamate dehydrogenase (microbial), ≥234 μkat/L; 2-oxoglutarate, 50 mmol/L; detergent; preservative; stabilizer.
2 NH3B R2	black	2 vials, 100 tests each	Reagent 2 (R2): NADPH, ≥1.0 mmol/L; buffer; preservative.

", "Name": "Content" }, { "Language": "en", "Value": "Ammonia is produced in cell cultures or in microbial fermentation as a waste product, and accumulation of ammonia can suppress cell growth and product formation. For monitoring in a culture process, ammonia 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 glutamate dehydrogenase.
Recovery: ±10%", "Name": "Specification" } ] } } ] }