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- Order Information", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Result differences between IGGLB, IGGHB and IGGHD
IGGLB, IGGHB and IGGHD are independent tests definitions. The Cedex Bio Analyzer, therefore, generates an individual calibration curve for each of these protocols. If the calibration curves happen to be somewhat different, a systematic difference in the results may be noted when the same sample is measured using the different test protocols, for example when the controls are measured after the calibration. This difference, however, is generally expected to be very small. If the difference is significant, try performing a new calibration for the tests. In this case, performing new calibrations for the tests may minimize the difference in results when the same sample is measured using the test protocols.
 
Potentially increased inaccuracy near the upper limit of the IGGHB test range
Under special circumstances, result values near the upper limit of the IGGHB test range may be lower than expected (up to 15 % lower in extreme cases).  This can occur when the individual sample IgG has a somewhat different affinity for the antibody in the assay reagent compared to the IgG in Calibrator A. This phenomenon may cause a deviation from the calibration curve, but only when the concentration of the IgG in the sample is close to the upper limit (< 1 g/L); measurement results in the lower and middle area of the range will be correct. When this occurs, Roche recommends using the IGGHD protocol to ensure that the concentration is well within the defined range and is, therefore, being measured correctly.", "Country": "XG", "Code": "Troubleshooting - Help Corner", "Name": "Troubleshooting - Help Corner" }, { "Language": "en", "Value": "
Immunoturbidimetric assay
The kit contains an antiserum directed against target structures in the constant region of the Fc part of IgG molecules (crystallizable fragment), which forms a precipitate with IgG in the assay. The precipitation is determined turbidimetrically at 340 nm. For low IgG concentrations, the protocol IGGLB uses the Accelerator reagent to boost the precipitation.", "Country": "XG", "Code": "Principle", "Name": "Principle" }, { "Language": "en", "Value": "
VialContentComposition
IGGBReagent cassette,
100 tests		Reagent 1 (R1): Anti-IgG antiserum (rabbit) specific for human IgG; phosphate buffer; preservative.
Start Reagent (SR): for antigen excess check; recombinant IgG; preservative.
", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "
Analyzer and accessories
  • Cedex Bio HT Analyzer*, including accessories and disposables
  • NaCl Diluent 9%* (ACN 07-5635-0)
  • Accelerator* (ACN 07-2186-7)
  • Cleaner Alkaline Bio HT* (ACN 07-64433-7)
  • Standard laboratory equipment
The NaCl Diluent 9%* is used for the automated dilution of calibrators and samples. It must be placed on board for all IgG protocols even if no dilution is ordered.
The Cleaner Alkaline Bio HT* is automatically used for thorough cleaning of the probes before running the highly sensitive IGGLB protocol in order to avoid any cross contamination. See chapter \"Extra wash cycle\".
The Accelerator* is automatically used for the highly sensitive IGGLB protocol for signal enhancement.
Calibrators and Controls
  • Calibrator A Bio*
  • Control A Level 2 Bio*
  • Control A Level 3 Bio*
", "Country": "XG", "Code": "Additional Equipment and Reagent Required", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Recombinant human IgG for therapeutical use is produced mostly in CHO cell cultures or alternatively in E. coli cultures. For monitoring of the product formation in the culture process, the IgG can be determined on a Cedex Bio or Cedex Bio HT Analyzer with high reliability, providing a more convenient alternative to the IgG determination by HPLC.", "Country": "XG", "Code": "Applications", "Name": "Applications" }, { "Language": "en", "Value": "Kit for determination of human IgG.", "Country": "XG", "Code": "Positioning", "Name": "Positioning" }, { "Language": "en", "Value": "Method: Immunoturbidimetric
Recovery: ±10%", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "
Test protocol
IgG concentrations can be determined in the following ranges depending on the selected test protocol, always using the same set of reagents. If a test result is flagged with the remark \"< test range\", \"> test range\", or \"> antigen excess\", then the analysis of the sample should be repeated with the appropriate test protocol.
Cedex Bio HT test definition
Test definitionIGGLB
(919)		IGGHB
(926)		IGGHD
(722)
Measuring range
     µmol/L
     mg/L		Low
0.067 – 0.533
10 – 80		Standard
0.53 – 10.7
80 – 1,600		High + dilution
2.7 – 53.4
400 – 8,000
Control levelA2 diluted 1:10A 2, 3A 2, 3
Extra wash cycle (EWC)Yes (Cleaner Alk.)NoNo
Sample predilutionNoNo1:5
Measuring modeAbsorbanceAbsorbanceAbsorbance
Abs. calc. modeEndpointEndpointEndpoint
Reaction modeR1-DL-S-SRR1-S-SRR1-S-SR
Reaction directionIncreaseIncreaseIncrease
Wavelength A/B340/652 nm340 nm340 nm
Calc. first/last18/3318/3318/33
Antigen access checkYes (SR)Yes (SR)Yes (SR)
Unitµmol/L, mg/Lµmol/L, mg/Lµmol/L, mg/L
Pipetting parameters
Pipetting parametersIGGLB(1)
(919)		IGGHB
(926)		IGGHD
(722)
NaCl Diluent 0.9% (Sample Predilution)(2)NoNo40 μL sample + 128 μL Diluent 9% + 32 μL water
R1100 µL + 5 μL water140 μL + 5 μL water140 μL + 5 μL water
Accelerator30 µLNoNo
Sample (S)25 µL2 μL + 20 μL water2 μL + 20 μL water
SR5 μL + 25 μL water5 μL + 25 μL water5 μL + 25 μL water
Total Volume190 µL177 μL177 μL
  1. 100 μL of Cleaner Alkaline is used before each IGGLB measurement as part of the extra wash cycle (EWC).
  2. Sample predilution is performed in a prior step, after which the reaction mix is prepared in the same way as the unmodified sample. 
Calibration
Calibration
CalibratorCalibrator A Bio (CAL A, 07-1100-4)
Calibration modeLogit/Log5
Calibration intervalEach new lot, and if recalibration is required due to QC results.
Quality control
Protocol IGGLB
  • Custom control: For quality control in the low range of test protocol IGGLB, prepare an appropriate control by 1:10 dilution of 'Control A Level 2 Bio' with 0.9% NaCl as diluent. A 0.9% NaCl solution can easily be prepared by 1:10 dilution of the NaCl Diluent 9% with water. The IgG concentration of the original control level 2 has to be divided by 10 for entering the lot-specific IgG value for the IGGLB control. The corresponding \"1s\" value should be divided by 5, to allow a slightly higher imprecision with the manual dilution step.
Protocols IGGHB and IGGHD
  • Control A Level 2 Bio (CONA2, 07-1103-9)
  • Control A Level 3 Bio (CONA3, 07-1104-7)

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.
Extra wash cycle
In order to prevent any potential influence by carry-over from samples with higher IgG concentrations, the IGGLB test for measurements in the low concentration range uses initially an extra wash cycle with the alkaline cleaner for the pipetting device. For information about creating extra wash cycles, refer to the Operator's manual. Program the EWC for the IGGLB with the following values:
TypeTestComponentWithVolume [µL]
BeforeIGGLBSampleCLEAN100
Conversion factors
Conversion factors for IgG concentration:
  • 1 mmol/L = 150.0 g/L
  • 1 g/L = 6.67 µmol/L
Typical value for human IgG; molecular weight may vary depending on source of IgG and glycosylation grade.
Traceability
This method has been standardized against net weight of a reference material of subtype IgG1.
Precision
Representative performance data on Cedex Bio HT Analyzers are shown. Results obtained in individual laboratories may differ. Precision was determined in samples of two concentration levels. Coefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 10 days).
 Level 1Level 2
Mean3.80 µmol/L (570 mg/L)6.95 µmol/L (1,043 mg/L)
CV in-run [%]0.70.6
CV inter-run [%]1.51.2
", "Country": "XG", "Code": "Protocols", "Name": "Protocols" } ] } } ] }

IgG Bio HT

Test kit for the Cedex Bio HT Analyzer

Cedex IgG
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for certificates, method sheets (instructions for use), safety data sheets and software downloads
control-f-level-1-bio
Control F Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-calibrator-f-bio
Calibrator F Bio for Cedex Bio and Cedex Bio HT Analyzers
control-f-level-2-bio
Control F Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-calibrator-k-bio
Calibrator K Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-f-level-3-bio
Control F Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
Cedex Microcuvettes
Microcuvettes Bio HT Consumable for the Cedex Bio HT Analyzer
control-d-level-3-bio
Control D Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
cleaner-alkaline-bio-ht
Cleaner Alkaline Bio HT System reagent for the Cedex Bio HT Analyzer
calibrator-a-bio
Calibrator A Bio for Cedex Bio and Cedex Bio HT Analyzers
control-d-level-1-bio
Control D Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
control-b-level-1-bio
Control B Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
control-b-level-2-bio
Control B Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
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Waste Container Bio HT Consumable for the Cedex Bio HT Analyzer
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Accelerator, 100 mL System reagent for the Cedex Bio HT Analyzer
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Activator Bio System reagent for the Cedex Bio and Cedex Bio HT Analyzers
cb-adapter-cups
Adapter Cups Accessory for the Cedex Bio and Cedex Bio HT Analyzers
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NaCl Diluent 9% System reagent for the Cedex Bio HT Analyzer
Opening Tool Cedex Bio HT
Opening Tool Bio HT Accessory for the Cedex Bio HT Analyzer
Pyruvate Bio HT
Pyruvate Bio HT Test kit for the Cedex Bio HT Analyzer
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ISE Deproteinizer Bio HT System reagent for the Cedex Bio HT Analyzer
Phosphate Bio HT
Phosphate Bio HT Test kit for the Cedex Bio HT Analyzer
cedex-control-e-level-3-bio
Control E Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-d-level-2-bio
Control D Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-od-level-2-bio
Control OD Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-c-level-1-bio
Control C Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-calibrator-b-bio
Calibrator B Bio for Cedex Bio and Cedex Bio HT Analyzers
control-a-level-1-bio
Control A Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
control-c-level-2-bio
Control C Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-b-level3-bio
Control B Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-a-level3-bio
Control A Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
control-a-level-2-bio
Control A Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-calibrator-e-bio
Calibrator E Bio for Cedex Bio and Cedex Bio HT Analyzers
control-c-level-3-bio
Control C Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
calibrator-d-bio
Calibrator D Bio for Cedex Bio and Cedex Bio HT Analyzers
control-od-level1-bio
Control OD Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
control-e-level-2-bio
Control E Level 2 Bio for Cedex Bio and Cedex Bio HT Analyzers
control-od-level-3-bio
Control OD Level 3 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-control-e-level-1-bio
Control E Level 1 Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-calibrator-c-bio
Calibrator C Bio for Cedex Bio and Cedex Bio HT Analyzers
cedex-cleaner-acidic
Cleaner Acidic System reagent for the Cedex Bio and Cedex Bio HT Analyzers
Cedex 96 well plate kit
Kit 96-well plate Cedex Accessory for the Cedex Bio HT Analyzer
cedex
Rack 96-well plate Cedex Accessory
Nitrate Bio HT
Nitrate Bio HT Test kit for the Cedex Bio HT Analyzer
asparagine-bio-ht
Asn/Asp Bio HT Test kit for the Cedex Bio HT Analyzer
acetate
Acetate V2 Bio HT Test kit for the Cedex Bio HT Analyzer
cedex-ala-gln-bio-ht
Ala-Gln Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Ig Fab
Ig Fab Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Iron
Iron Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Formate
Formate Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex NH3
NH3 Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Glycerol
Glycerol Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Glutamine
Glutamine V2 Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Glucose
Glucose Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Galactose Arabinose
Galactose/Arabinose Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Glutamate
Glutamate V2 Bio HT Test kit for the Cedex Bio HT Analyzer
Optical Density Cedex Bio HT
OD Bio HT Test kit for the Cedex Bio HT Analyzer
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Total Protein Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex LDH
LDH Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Lactate
Lactate Bio HT Test kit for the Cedex Bio HT Analyzer
Potassium Bio HT
Potassium Bio HT Test kit for the Cedex Bio HT Analyzer
cedex-ethanol-bio-ht
Ethanol Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Mouse IgG
Mouse IgG Bio HT Test kit for the Cedex Bio HT Analyzer
Cedex Magnesium
Magnesium V2 Bio HT Test kit for the Cedex Bio HT Analyzer
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Sodium Bio HT Test kit for the Cedex Bio HT Analyzer
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Sucrose Bio HT Test kit for the Cedex Bio HT Analyzer
cedex-cholesterol-bio-ht
Cholesterol Bio HT Test kit for the Cedex Bio HT Analyzer
cedex-calcium-bio-ht
Calcium Bio HT Test kit for the Cedex Bio HT Analyzer
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