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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 4 weeks.
", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "
VialContentComposition
TP2BReagent cassette,
300 tests
Reagent 1 (R1): Sodium hydroxide, 400 mmol/L, pH 13.4; sodium potassium tartrate, 89 mmol/L; non-reactive surfactant.
Start Reagent (SR): Sodium hydroxide, 400 mmol/L, pH 13.2; sodium potassium tartrate, 89 mmol/L; potassium iodide, 61 mmol/L, pH 7.3; copper(II) sulfate, 24.3 mmol/L; non-reactive surfactant; preservative.
", "Name": "Content" }, { "Language": "en", "Value": "Test ProtocolTP2B is the standard protocol for total protein determination.If the protein concentration of samples is expected to be lower than 4 g/L, use the protocol TP2LB, which has a higher sensitivity (15-fold higher sample input). If the protein concentration of samples is higher than 120 g/L, use protocol TP2D (same protocol with preset 1:10 sample predilution).
Test definitionTP2LBTP2BTP2D
RangeLow range0.3 to 6.0 g/LHigh range4 to 120 g/LHigh + dilution40 to 1200 g/L
PredilutionNoNo1:10
Measuring modeAbsorbanceAbsorbanceAbsorbance
Abs. calc. modeEndpointEndpointEndpoint
Reaction modeR1-S-SRR1-S-SRR1-S-SR
Reaction directionIncreaseIncreaseIncrease
Wavelength552/659 nm552/659 nm552/659 nm
Calculation first/last33/5233/5233/52
Unitg/Lg/Lg/L
PipettingparametersTP2LBTP2BTP2D
SamplepredilutionNoNo20 μL+ 180 μL H2O
R190 μL90 μL90 μL
Sample30 μL2 μL+ 28 μL H2O2 μL+ 28 μL H2O
SR32 μL32 μL32 μL
Total volume152 μL152 μL152 μL
Calibration:Calibrator                 Calibrator A Bio (CAL A, 07-1100-4)Calibration mode      Linear regressionCalibration interval   TP2B; TP2D: Each lot, and if recalibration is required due to QC results.                                 TP2BL: After 7 days, and if recalibration is required due to QC results.Quality control:Control A Level 1 Bio (CONA1, 07-1101-2)Control A Level 2 Bio (CONA2, 07-1103-9)Control A Level 3 Bio (CONA3, 07-1104-7)Use the recommended control material. For quality control in the low range of test protocol TP2LB, prepare an appropriate control by diluting \"Control A Level 1 Bio\" 1:10 using water as the diluent. Divide the Total Protein concentration of the original control level 1 by 10 for entering the lot-specific Total Protein value. The corresponding \"1s\" value should be divided by 5, to allow a slightly higher imprecision with the manual dilution step. 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": "Kit for determination of the total protein concentration.", "Name": "Product Description" }, { "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 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": "Total protein concentration can be determined in following range:
  • TP2LB: 0.3 to 6.0 g/L
  • TP2B: 4 to 120 g/L
  • TP2D: 40 g/L up to maximal solubility
TraceabilityThis method has been standardized against a standard reference material (SRM 927).PrecisionRepresentative 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 1Level 2Level 3
Mean52.6 g/L65.4 g/L92.0 g/L
CV in-run0.5%0.5%1.0%
CV inter-run1.0%1.5%2.2%
", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "In the process control of cell cultures and microbial fermentation, as well as in a down-stream protein isolation process, the generic determination of the total protein concentration can be used for control of culture media, for monitoring of the increase of secreted protein products in a culture, and to check the content of a purified protein in an isolation process. The total protein 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 biuret reaction with copper ions.
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 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" } ] } } ] }

Total Protein Bio HT

Test kit for the Cedex Bio HT Analyzer

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