{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "ProductType": "Others", "DisclaimerGroup2": null, "ProductNameGlobal": "Cholesterol Bio", "DisclaimerGroup1": "Non-IVD", "ControlTissue": [ "" ], "BrandName": "Cholesterol Bio", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.2.4.15", "ProductNameAddition": "Test kit for the Cedex Bio Analyzer", "Species": [ "" ], "Clone": "" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_07374577001_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": "07374577001", "MaterialDescription": "Cholesterol Bio", "RegisteredProductName": "Cholesterol Bio", "GTIN": "07613336131114", "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": "3.8.10.1.2.19", "BrandName": "Calibrator B 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": "3.8.10.1.2.22", "BrandName": "Control B Level 3 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": "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 reagent is stable for up to 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "This product is intended for quantitative determination of cholesterol in aqueous solutions using the Cedex Bio Instrument.", "Name": "Product Description" }, { "Language": "en", "Value": "

Vial	Cap	Content	Composition
1 CHO2B R1	white	2 vials, 100 tests each	Reagent 1 (R1): PIPES, 225 mmol/L, pH 6.8; choline esterase (Pseudomonas spec.), ≥1.5 kU/L; cholesterol oxidase (E. coli), ≥0.45 kU/L; horseradish peroxidase, ≥0.75 kU/L; Mg2+, 10 mmol/L; 4-aminoantipyrine, ≥0.45 mmol/L; phenol, ≥12.6 mmol/L; sodium cholate, 0.6 mmol/L; non-reactive preservative; stabilizer.

", "Name": "Content" }, { "Language": "en", "Value": "Quality control check of the CHO2D (dilution) protocol is not possible with Control B Level 2 and 3 Bio
It is not possible to use Control B Bio Level 2 and Control B Bio Level 3 as a quality control check of the CHO2D (dilution) protocol for the Cholesterol Bio test. The results from the check with the controls will fail due to the nature of the analyte cholesterol. Analyte cholesterol is a hydrophobic substance and is, therefore, usually bound to transport proteins in biological samples. In the Control B set a different approach is used to keep cholesterol in solution. The mechanism used to keep the cholesterol in solution is disturbed when the Control B is diluted with water, which is done automatically in the CHO2D protocol. The consequence is that the recovery is decreased when using the dilution protocol. Therefore, the Control B Level 2 Bio and Control B Level 3 Bio fail in the CHO2D protocol, that is, the results are out of the recommended 3s range. The controls work in the CHO2B protocol, and the result is within the expected 3s range, because the Control B is not diluted with water.
 
The failed QC does not indicate that the calibration of the CHO2D protocol is incorrect. The calibration of the CHO2D protocol is identical to the calibration of the CHO2B protocol. The only difference is that the sample is always pre-diluted 1:10 in water when using the CHO2D protocol. Nevertheless, since the CHO2D protocol is a separate protocol, it also requires a separate calibration and consequently also requests a separate QC check. The Control B set cannot be used to do the QC check for the CHO2D protocol of the Cholesterol Bio and Bio HT assay. Consequently, customers can either accept validity of the calibration without the use of controls to check by the fact that the calibration is not flagged, or they can define their own biological controls to check validity of the calibration that can be diluted with water without showing the above explained phenomenon.  Alternatively, samples can be measured with the CHO2B protocol only. If the sample cholesterol concentration is too high, the sample can be diluted by the system after the first measurement is flagged. However, this means that a sample may be measured twice.
 
Dilution of biological samples with water is possible since the cholesterol in such samples is bound differently than in our Control B set. Thus, this phenomenon should not have an effect on the cholesterol solubility in biological samples. However, this needs to be validated by the customer in their individual application.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Cholesterol concentration can be determined in following range

• CHO2B: 9.67 to 800 mg/L (0.025 to 2.07 mmol/L)
• CHO2D: 96.7 to 8000 mg/L (0.25 to 20.7 mmol/L),

up to 80 g/L (207 mmol/L) with postdilution

Conversion factors for cholesterol concentration

• 1 mmol/L = 386.6 mg/L
• 1 mg/L = 2.59 μmol/L

Traceability
This method has been standardized against isotope dilution mass spectrometry (ID-MS) and according to Abell-Kendall.

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	0.24 mmol/L (94 mg/L)	0.49 mmol/L (189 mg/L)	1.09 mmol//L (421 mg/L)
CV in-run	0.5 %	0.7 %	0.7 %
CV inter-run	1.0 %	1.1 %	1.4 %

", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "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": "Cholesterol is a major component of all biological membranes. In cell cultures, cholesterol can be produced by the cells, nevertheless, a certain level of cholesterol in the culture medium is advantageous for cell growth and viability. With a controlled cholesterol concentration, cells grow faster and to higher density. For control of culture media and for monitoring in a culture process, the cholesterol concentration 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 cholesterol oxidase.
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" } ] } } ] }