{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Phosphate Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Phosphate Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.10", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06990070001_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": "06990070001", "MaterialDescription": "Phosphate Bio", "RegisteredProductName": "Phosphate Bio", "GTIN": "07613336101230", "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": "3.8.10.1.2.18", "BrandName": "Control A Level 3 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": "3.8.10.1.2.16", "BrandName": "Control A Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.17", "BrandName": "Control A Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] }, "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 reagents are stable for up to 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Kit for determination of phosphate.", "Name": "Product Description" }, { "Language": "en", "Value": "PHO2B is the standard protocol for phosphate determination.
If the phosphate concentration of samples is higher than 8.3 mmol/L (795 mg/L), protocol PHO2D should be used (same protocol with preset 1:11 sample predilution).
Results higher than the valid measuring range will be flagged and a rerun with an automatic 1:11 predilution will be recommended by the software.

Cedex Bio test definition

• Measuring mode              Absorbance
• Abs. calculation mode     Endpoint
• Reaction direction            Increase
• Wavelength A/B                340/659 nm
• Calc. first/last                    16/34
• Unit                                      mmol/L
• Reaction mode                 R1-S-SR

Pipetting parameters

• R1                                       90 μl
• Sample                              2.5 μl + 27.5 μl Diluent (H2O)
• SR                                      38 μl
• Total volume                     158 μl

Calibration

• Calibrator                          Calibrator A Bio (CAL A, 599)
• Calibration mode             Linear regression
• Calibration interval          Each new lot, and if recalibration is required due to QC results

Quality controls

• Control 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. 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": "

Vial	Cap	Content	Composition
1 PHO2B R1	white	4 vials, 50 tests each	Reagent 1 (R1): Sulfuric acid, 0.36 mol/L; non-reactive surfactant.
2 PHO2B SR	black	4 vials, 50 tests each	Start Reagent (SR): Ammonium molybdate, 3.5 mmol/L; sulfuric acid, 0.36 mol/L; sodium chloride, 150 mmol/L.

", "Name": "Content" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Phosphate concentration can be determined in following range

• PHO2B: 9.5 to 795 mg/L (0.1 to 8.36 mmol/L)
• PHO2D: 105 to 8745 mg/L (1.1 to 92 mmol/L),

up to 96 g/L (1 mol/L) with postdilution

Conversion factors for phosphate concentration

• 1 mmol/L = 94.97 mg/L
• 1 mg/L = 10.53 μmol/L

Traceability
This method has been standardized against a primary reference material (NERL).

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 10 days).

	Level 1	Level 2	Level 3
Mean	0.40 mmol/L (38.0 mg/L)	1.12 mmol/L (106 mg/L)	5.1 mmol/L (484 mg/L)
CV in-run	1.3%	0.5%	0.3%
CV inter-run	1.3 %	0.8%	0.8%

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

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

• 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": "Phosphate is a mineral nutrient, which is reqired in cell cultures and microbial fermentation for optimal growth and product formation. For control of culture media and for monitoring in a culture process, the phosphate 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 detection with ammonium molybdate.
Recovery: ±10%", "Name": "Specification" }, { "Language": "en", "Value": "

• 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.

• 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" } ] } } ] }