{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "Calcium Bio", "DisclaimerGroup1": "", "ControlTissue": [ "" ], "BrandName": "Calcium Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.11", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "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 6 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "English", "Value": "Store the reagent at +2 to +8°C.", "Name": "Storage Conditions (Product)" }, { "Language": "English", "Value": "

• Cedex Bio 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": "English", "Value": "Method: Colorimetric detection with NM-BAPTA.
Recovery: ±10%", "Name": "CB - Specification" }, { "Language": "English", "Value": "CA2B is the standard protocol for calcium determination. If the calcium concentration of samples is higher than 5 mmol/L (200 mg/L), protocol CA2D 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            Decrease
Wavelength A/B                340/378 nm
Calc. first/last                    16/18
Unit                                      mmol/L
Reaction mode                 R1-S-SR

Pipetting parameters
R1                                       20 μl + 130 μl Diluent (H2O)
Sample                              3 μl + 30 μl Diluent (H2O)
SR                                      20 μl
Total volume                     203 μl

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

Quality controls
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": "English", "Value": "Calcium concentration can be determined in following ranges

• CA2B: 8 to 200 mg/L (0.2 to 5.0 mmol/L)
• CA2D: 80 to 2000 mg/L (2 to 50 mmol/L)

up to 20 g/L (500 mmol/L) with postdilution

Conversion Factors
Conversion factors for calcium concentration:

• 1 mmol/L = 40.08 mg/L
• 1 mg/L = 24.95 μmol/L

Traceability
This method has been standardized against a primary standard material (SRM 956 c level 2).

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	0.59 mmol/L (23.7 mg/L)	2.29 mmol/L (91.8 mg/L)	3.59 mmol/L (144 mg/L)
CV in-run	1.5%	0.6%	0.5%
CV inter-run	2.1%	1.8%	1.9%

", "Name": "Background Information - Help Corner" }, { "Language": "English", "Value": "Calcium ions react with 5-nitro-5′-methyl-BAPTA (NM-BAPTA) under alkaline conditions to form a complex which can be measured photometrically at 340 nm. In a second step, calcium is released from the complex by the stronger chelator EDTA, and the change in photometric absorbance is directly proportional to the calcium concentration.", "Name": "Principle" }, { "Language": "English", "Value": "This product is intended for quantitative determination of calcium in aqueous solutions using the Cedex Bio Instrument.", "Name": "Product Description" }, { "Language": "English", "Value": "

Vial	Cap	Content	Composition
1 CA2B R1	white	2 vials, 100 tests each	Reagent 1 (R1): CAPSO, 557 mmol/L, pH 10.0; 5-nitro-5′-methyl-BAPTA (NM-BAPTA), 2 mmol/L; non-reactive surfactant; preservative.
2 CA2B SR	black	2 vials, 100 tests each	Start Reagent (SR): EDTA, 7.5 mmol/L, pH 7.3; non-reactive surfactant; preservative.

", "Name": "Content" }, { "Language": "English", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "English", "Value": "Calcium 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 calcium concentration can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability and convenience.", "Name": "Applications" }, { "Language": "English", "Value": "Method: Colorimetric detection with NM-BAPTA.
Recovery: ±10%", "Name": "Specification" } ] } }, "Product2Taxomony": { "Product2TaxomonyReferences": [ { "StructureSystemName": "OWP Product Solutions", "NodeName": "CustomBiotech", "StructureSystemID": null, "NodeID": "520" }, { "StructureSystemName": "OWP Product Types", "NodeName": "Assays, Reagents and Strips", "StructureSystemID": null, "NodeID": "20-000-00" }, { "StructureSystemName": "OWP Organization", "NodeName": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureSystemID": null, "NodeID": "01-01-01-07-00" }, { "StructureSystemName": "Product Grouping", "NodeName": "CustomBiotech->Cedex Bio Analyzer Products", "StructureSystemID": null, "NodeID": "02-0009" }, { "StructureSystemName": "OWP Family", "NodeName": "Cedex", "StructureSystemID": null, "NodeID": "490" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "07374623001", "MaterialDescription": "Calcium Bio", "RegisteredProductName": "", "GTIN": "07613336101209", "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": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.26", "BrandName": "Control C Level 2 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.25", "BrandName": "Control C Level 1 Bio", "ProductNameAddition": "Control reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" }, { "ProductID": "3.8.10.1.2.24", "BrandName": "Calibrator C Bio", "ProductNameAddition": "Calibrator reagent for the Cedex Bio and Cedex Bio HT Analyzers", "ReferenceType": "Reagent" } ] } }