{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Total Protein Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Total Protein Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.14", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07374593001_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": "07374593001", "MaterialDescription": "Total Protein Bio", "RegisteredProductName": "Total Protein Bio", "GTIN": "07613336133224", "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": "3.8.10.1.2.17", "BrandName": "Control A 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": "3.8.10.1.2.18", "BrandName": "Control A Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.16", "BrandName": "Control A Level 1 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 +15 to +25°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 reagents are stable for up to 4 weeks.

Before use on the instrument, insert a \"Chimney\" into each bottle of R1 (white) and SR (black). The Chimneys are plastic tubes that protect the reagents on board by reducing CO₂ uptake and evaporation. The same Chimney can be used for all bottles of the same reagent R1 or SR from one box. Avoid contamination when using the Chimney.

", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 TP2B R1	white	2 vials, 100 tests each	Reagent 1 (R1): Sodium hydroxide, 400 mmol/L, pH 13.4; sodium potassium tartrate, 89 mmol/L; non-reactive surfactant.
2 TP2B SR	black	2 vials, 100 tests each	Start Reagent (SR): Sodium hydroxide, 400 mmol/L, pH 13.2; sodium potassium tartrate, 89 mmol/L; potassium iodide, 61 mmol/L, pH 7.3; copper(II) sulfate, 24.3 mmol/L; non-reactive surfactant; preservative.

", "Name": "Content" }, { "Language": "en", "Value": "Total protein concentration can be determined in following range:

• TP2LB: 0.3 to 6.0 g/L
• TP2B: 4 to 120 g/L
• TP2D: 40 g/L up to maximal solubility

TraceabilityThis method has been standardized against a standard reference material (SRM 927).PrecisionRepresentative 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	22.4 g/L	46.3 g/L	83.4 g/L
CV in-run	1.3%	1.5%	0.6%
CV inter-run	3.1%	1.8%	1.7%

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Kit for determination of the total protein concentration.", "Name": "Product Description" }, { "Language": "en", "Value": "

Analyzer and accessories

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

Calibrators and Controls

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

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Test ProtocolTP2B is the standard protocol for total protein determination.If the protein concentration of samples is expected to be lower than4 g/L, use the protocol TP2LB, which has a higher sensitivity (15-fold higher sample input).If the protein concentration of samples is higher than 120 g/L, use protocol TP2D (same protocol with preset 1:10 sample predilution).

Test definition	TP2LB	TP2B	TP2D
Range	Low range0.3 to 6.0 g/L	High range4 to 120 g/L	High + dilution40 to 1200 g/L
Predilution	No	No	1:10
Measuring mode	Absorbance	Absorbance	Absorbance
Abs. calc. mode	Endpoint	Endpoint	Endpoint
Reaction mode	R1-S-SR	R1-S-SR	R1-S-SR
Reaction direction	Increase	Increase	Increase
Wavelength	552/659 nm	552/659 nm	552/659 nm
Calculation first/last	16/33	16/33	16/33
Unit	g/L	g/L	g/L

Pipettingparameters	TP2LB	TP2B	TP2D
Samplepredilution	No	No	20 μL+ 180 μL H2O
R1	90 μL	90 μL	90 μL
Sample	30 μL	2 μL+ 28 μL H2O	2 μL+ 28 μL H2O
SR	32 μL	32 μL	32 μL
Total volume	152 μL	152 μL	152 μL

CalibrationCalibrator                 Calibrator A Bio (CAL A, 07-1100-4)Calibration mode      Linear regressionCalibration interval   TP2B; TP2D: Each lot, and if recalibration is required due to QC results.                                 TP2BL: After 7 days, and if recalibration is required due to QC results.Quality controlsControl A Level 1 Bio (CONA1, 111)Control A Level 2 Bio (CONA2, 112)Control A Level 3 Bio (CONA3, 113)Use the recommended control material. For quality control in the low range of test protocol TP2LB, prepare an appropriate control by diluting \"Control A Level 1 Bio\" 1:10 using water as the diluent. Divide the Total Protein concentration of the original control level 1 by 10 for entering the lot-specific Total Protein value. The corresponding \"1s\" value should be divided by 5, to allow a slightly higher imprecision with the manual dilution step. 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": "In the process control of cell cultures and microbial fermentation, as well as in a down-stream protein isolation process, the generic determination of the total protein concentration can be used for control of culture media, for monitoring of the increase of secreted protein products in a culture, and to check the content of a purified protein in an isolation process. The total protein concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Colorimetric biuret reaction with copper ions.
Recovery: ±10%", "Name": "Specification" }, { "Language": "en", "Value": "

Precautions

• Handle all samples as if potentially infectious, using safe laboratory procedures. As the sensitivity and titer of potential pathogens in the sample material can vary, the operator must optimize pathogen inactivation and follow the appropriate measures according to local safety regulations.
• Do not eat, drink, or smoke in the laboratory work area.
• Do not pipette by mouth.
• Wear protective disposable gloves, laboratory coats, and eye protection, when handling samples and kit reagents.
• Wash hands thoroughly after handling samples and reagents.

Waste handling

• Discard unused reagents and waste in accordance with country, federal, state, and local regulations.
• Safety Data Sheets (SDS) are available online at documentation.roche.com, or upon request from the local Roche office.

", "Name": "Safety Information" } ] } } ] }