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"Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" } ] } ] }, "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. After first use on the instrument, the reagents are stable for up to 8 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Measuring Range
Cholesterol concentration can be determined in following ranges:
  • CHO2B: 3.87 - 800 mg/L (0.01 - 2.07 mmol/L)
  • CHO2D: 38.7 - 8.000 mg/L (0.1 - 20.7 mmol/L),
up to 80 g/L (207 mmol/L) with automatic dilution

Conversion Factors
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 by Isotope dilution mass spectrometry (ID-MS) and according to Abell-Kendall.

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 10 days).
 Level 1Level 2Level 3
Mean\t\t0.051 mmol/L
(20 mg/L)\t\t\t   
0.12 mmol/L
(46 mg/L)\t\t\t  
1.39 mmol/L
(537 mg/L)
CV in-run1.4 %1.3 %0.2 %
CV inter-run   1.9 %1.4 %1.2 %
", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "
Test protocol
Cedex Bio HT test definition
Test definitionCHO2B
(751)
CHO2D
(752)
Measuring range
     mmol/L
     mg/L
Standard
0.01 – 2.07
3.87 – 800
High
0.1 – 20.7(1) 
38.7 – 8,000(1)
Control levelB 1, 2, 3Custom
Sample predilutionNoNo
Measuring modeAbsorbanceAbsorbance
Abs. calc. modeEndpointEndpoint
Reaction modeR-SR-S
Reaction directionIncreaseIncrease
Wavelength A/B512/659 nm512/659 nm
Calc. first/last17/6917/69
Unitmmol/L, mg/Lmmol/L, mg/L
  1. Up to 207 mmol/L (80 g/L) with automatic dilution.
Pipetting parameters
Pipetting parametersCHO2B
(751)
CHO2D
(752)
Water Diluent (Sample Predilution)NoNo
R47 μL + 55 μL water47 μL + 55 μL water
Sample (S)20 μL + 20 μL water20 μL + 20 μL water
Total Volume142 μL142 μL
Calibration
Calibration
CalibratorCalibrator B Bio (CAL B, 07-1105-5)
Calibration modeLinear regression
Calibration intervalEach new lot, and if recalibration is required due to QC results.
Quality control
Protocol CHO2B
  • Control B Level 1 Bio (CONB1, 07-1106-3)
  • Control B Level 2 Bio (CONB2, 07-1107-1)
  • Control B Level 3 Bio (CONB3, 07-1109-8)
Protocol CHO2D
  • Custom control: For quality control of CHO2D, use custom controls with cholesterol concentrations in the high range of 0.15 to 7.5 g/L. Ensure that the cholesterol in the control material stays in solution during the automatic 1:10 dilution step with water.
    The cholesterol in the Controls B Level 1-3 Bio is stabilized but begins to precipitate if diluted with water. Therefore, these controls are not suitable for control of the CHO2D protocol because the automatic dilution step may cause too low recovery of cholesterol.

Use the recommended control material. Other suitable control material can also be used.
Control intervals and acceptance limits should be adapted to each lab\u00adoratory's individual requirements. If values do not fall within the defined limits, corrective measures and recalibration are required.
Conversion factors
Conversion factors for cholesterol concentration:
  • 1 mmol/L = 386.6 mg/L
  • 1 g/L = 2.59 mmol/L
Traceability
This method has been standardized by isotope dilution mass spectrometry (ID-MS) and according to Abell-Kendall.
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 10 days).
 Level 1Level 2Level 3
Mean0.051 mmol/L (20 mg/L)0.12 mmol/L (46 mg/L)1.39 mmol/L (537 mg/L)
CV in-run [%]1.41.30.2
CV inter-run [%]1.91.41.2
", "Name": "Protocols" }, { "Language": "en", "Value": "
VialContentComposition
CHO2BReagent cassette,
400 tests
Reagent: 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": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "
Analyzer and accessories
  • Cedex Bio HT Analyzer*, including accessories and disposables
  • Standard laboratory equipment
Calibrators and Controls
  • 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": "This product is intended for quantitative determination of cholesterol in aqueous solutions using the Cedex Bio HT Analyzer.", "Name": "Product Description" }, { "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": "
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" } ] } } ] }

Cholesterol Bio HT

Test kit for the Cedex Bio HT Analyzer

cedex-cholesterol-bio-ht

Overview

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Technical documents

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