{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Iron Bio HT", "DisclaimerGroup1": null, "ControlTissue": [ "" ], "BrandName": "Iron Bio HT", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.", "ID": "3.8.10.3.4.9", "ProductNameAddition": "Test kit for the Cedex Bio HT Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_06990053001_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": "06990053001", "MaterialDescription": "Iron Bio HT", "RegisteredProductName": "Iron Bio HT", "GTIN": "07613336131947", "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": "3.8.10.1.2.27", "BrandName": "Control C Level 3 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.26", "BrandName": "Control C Level 2 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.25", "BrandName": "Control C Level 1 Bio", "ProductNameAddition": "for Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.24", "BrandName": "Calibrator C 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.
\nAfter first use on the instrument, the reagent is stable for up to 6 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Application FE2B (765), FE2D (796)

Cedex Bio HT test definition:
Measuring mode                  Absorbance
Abs. calculation mode          Endpoint
Reaction direction\t\t\t\tIncrease
Wavelength A/B                   552/659 nm
Calc. first/last                       49/55
Unit                                       μmol/L
Reaction mode                     R1-S-SR

Pipetting parameters:
R1\t\t\t\t\t\t\t\t\t\t   100 μL
Sample\t\t\t\t\t\t\t\t   8.5 μL + 11.5 μL Diluent (H2O)
SR\t\t\t\t\t\t\t\t\t\t   20 μL + 20 μL Diluent (H2O)
Total volume\t\t\t\t\t\t 160 μL

Calibration:
Calibrator\t\t\t\t\t\t\t   Calibrator C Bio (CAL C, 484)
Calibration mode\t\t\t\t  Linear regression
Calibration interval\t\t\t\tEach new lot, and if recalibration is required due to QC results

Quality control:
Control C Level 1 Bio (CONC1, 501)
Control C Level 2 Bio (CONC2, 502)
Control C Level 3 Bio (CONC3, 503)

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": "Due to its test design, the assay detects both Fe²⁺ and Fe³⁺ irons

The Iron assay detects all solved iron, independently of the oxidation state (Fe²⁺ or Fe³⁺). This is a requirement for the assay, because Fe²⁺ easily converts to Fe³⁺ in presence of oxygen and backwards. In a first step of the assay, Fe ions are released from complexes and Fe³⁺ is reduced to Fe²⁺. Then the total Fe²⁺ reacts with the chromogenic reagent for detection:

• Complexed iron is liberated at pH<2, resulting in free iron ions.
• Fe³⁺ ions are reduced by ascorbate to Fe²⁺
• Fe²⁺ ions and FerroZine form a colored complex
• The absorbance measured at 552nm is directly proportional to the iron concentration of the sample (Fe²⁺ and Fe³⁺ irons)

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

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

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

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "This product is intended for quantitative determination of iron ions in aqueous solutions using the Cedex Bio HT Analyzer.", "Name": "Product Description" }, { "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 pro\u00adtection, 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 dialog.roche.com, or upon request from the local Roche office.

", "Name": "Safety Information" }, { "Language": "en", "Value": "

Vial	Content	Composition
FE2B	Reagent cassette, 200 tests	Reagent 1 (R1): Citric acid, 200 mmol/L, thiourea, 115 mmol/L; non-reactive surfactant.
Start Reagent (SR): Sodium ascorbate, 150 mmol/L; FerroZine, 6 mmol/L; preservative.

", "Name": "Content" }, { "Language": "en", "Value": "Iron is an essential trace metal required in cell cultures and microbial fermentation. For optimal cell growth and product formation the iron concentration has to be kept whithin an appropriate concentration range, providing sufficient nutrition and avoiding toxical inhibition. For control of culture media and for monitoring in a culture process, the iron 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 FerroZine.
Recovery: ±10%", "Name": "Specification" }, { "Language": "en", "Value": "Measuring Range
Iron concentration can be determined in following ranges:

• FE2B: 0.05 - 10.0 mg/L, (0.9 - 179 μmol/L)
• FE2D: 0.5 - 100.0 mg/L (9 - 1,790 μmol/L),

up to 1 g/L (17.9 mmol/L) with automatic dilution
Conversion Factors
Conversion factors for phosphate concentration:

• 1 μmol/L = 0.0559 mg/L
• 1 mg/L = 17.89 μmol/L

Traceability
This method has been standardized against a primary standard reference material (SRM 937).

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 21 days).

	Level 1	Level 2	Level 3
Mean	11.2 mmol/L (0.63 mg/L)	19.9 mmol/L (1.11 mg/L)	30.7 mmol/L (1.72 mg/L)
CV in-run	1.0%	0.9%	0.5%
CV inter-run	2.3%	1.3%	1.3%

", "Name": "Background Information" } ] } } ] }