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APPLICABLE" } ] }, { "ProductID": "3.8.10.2.3.6", "BrandName": "Cleaner Alkaline Bio", "ProductNameAddition": "System reagent for the Cedex Bio Analyzer", "ReferenceType": "Reagent", "Classification": [ { "IdentifierofStructureSystem": "OWP_Organization", "NameofStructureSystem": "Organization", "StructureNodeID": "01-01-01-07-00", "StructureGroupPath": "Roche Diagnostics Solution (RDS)->Customer Areas->Core lab->CustomBiotech and LifeScience", "StructureGroupName": "CustomBiotech and LifeScience" }, { "IdentifierofStructureSystem": "Product_Grouping", "NameofStructureSystem": "Product Grouping", "StructureNodeID": "02-0009", "StructureGroupPath": "CustomBiotech->Cedex Bio Analyzer Products", "StructureGroupName": "Cedex Bio Analyzer Products" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "40-000-00", "StructureGroupPath": "Accessories", "StructureGroupName": "Accessories" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "490", "StructureGroupPath": "Cedex", "StructureGroupName": "Cedex" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "520", "StructureGroupPath": "CustomBiotech", "StructureGroupName": "CustomBiotech" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "180-00", "StructureGroupPath": "Manufacturing", "StructureGroupName": "Manufacturing" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "NOT APPLICABLE", "StructureGroupName": "NOT APPLICABLE" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "Chapters": [ { "Language": "en", "Value": "Store at +2 to +8°C and at +2 to +10°C for on-board use.
\nOn-board stability: After first use on the analyzer, the reagents are stable for up to 4 weeks.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Conversion Factors
\nConversion factors for IgG concentration:\n
    \n\t
  • 1 mmol/L = 150.0 g/L
  • \n\t
  • 1 g/L = 6.67 μmol/L
  • \n
\n(typical value for human IgG, molecular weight may vary depending on type of IgG and glycosylation grade).
\n
\nTraceability
\nThis method has been standardized against net weight of a reference material of subtype IgG1.
\n
\nPrecision
\nRepresentative performance data on Cedex Bio Analyzers are shown. Results obtained in individual laboratories may differ.
\nPrecision 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).
\n
\n \n\n\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\t\n\t\t\t\n\t\t\t\n\t\t\t\n\t\t\n\t\n
 Level 1Level 2
Mean3.90 \u0003µmol/L
\n\t\t\t(585 mg/L)
6.67 µmol/L
\n\t\t\t(1001 mg/L)
CV in-run0.6 %0.8 %
CV inter-run0.9 %1.7 %
\n
\n ", "Name": "Background Information - Help Corner" }, { "Language": "en", "Value": "Result differences between IGGLB, IGGHB and IGGHD
\nIGGLB, 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.
\n 
\nPotentially increased inaccuracy near the upper limit of the IGGHB test range
\nUnder 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.", "Name": "Troubleshooting - Help Corner" }, { "Language": "en", "Value": "This product is intended for quantitative determination of human Immunoglobulin G (IgG) in aqueous solutions using the Cedex Bio Analyzer.", "Name": "Product Description" }, { "Language": "en", "Value": "
Immunoturbidimetric assay
Human IgG forms a precipitate with a specific antiserum. The precipitation is determined turbidimetrically at 340 nm. For low IgG concentrations, the protocol IGGLB uses the Accelerator reagent to boost the precipitation.", "Name": "Principle" }, { "Language": "en", "Value": "
VialCapContentFunction/ Composition
1 IGGB R1white2 vials,
100 tests
each
Reagent 1 (R1): Anti-IgG antiserum (rabbit) specific for human IgG; phosphate buffer; preservative.
2 IGGB SRblack2 vials,
100 tests
each
Start Reagent (SR): For antigen excess check; recombinant IgG; preservative.
3 ACCB DIL 1white2 vials,
100 tests
each
Diluent (DIL): Accelerator for sensitive IgG detection; polyethylene glycol, 1%; sodium chloride, 0.9%; preservative.
", "Name": "Content" }, { "Language": "en", "Value": "
Analyzer and accessories
  • Cedex Bio Analyzer*, including accessories and disposables
  • Standard laboratory equipment
Calibrators and Controls
  • NaCl Diluent 9% Bio* (ACN 951)
  • Cleaner Alkaline Bio* (ACN 947)
  • Calibrator A Bio*
  • Control A Level 2 Bio*
  • Control A Level 3 Bio*
The NaCl Diluent 9% Bio* 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* 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\".
", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "Applications IGGLB (923), IGGHB (926), IGGHD (908)

Test protocols and measuring ranges
IgG concentrations can be determined in 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\" or \"> test range\", then the analysis of the sample should be repeated with the appropriate test protocol.

Test definitionIGGLB (923)IGGHB (926)IGGHD (908)
RangeLow range
10 - 80 mg/L
67 - 533 nmol/L
High range
80 - 1600 mg/L
0.53 - 10.7
\u0003µmol/L
High + dilution
0.4 - 8 g/L
2.7 - 53.4 µ\u0003mol/L
Measuring modeAbsorbanceAbsorbanceAbsorbance
Abs. calculation modeEndpointEndpointEndpoint
Extra wash cycle (EWC)YesNoNo
Sample PredilutionNoNo1 : 5
Reaction modeR1-DL-S-SRR1-S-SRR1-S-SR
Reaction directionIncreaseIncreaseIncrease
Wavelength A/B340/652 nm340 nm340 nm
Calculation first/last7/167/167/16
Antigen access checkYes (SR)Yes (SR)Yes (SR)
Displayed unitµ\u0003mol/L, mg/Lµ\u0003mol/L, mg/Lµ\u0003mol/L, mg/L

Pipetting parametersIGGLB (923)IGGHB (926)IGGHD (908)
Cleaner Alkaline (EWC)100 \u0003µL--
NaCl Diluent 9% (Sample Predilution)--1:5
R1100 µ\u0003L
+ 5 µ\u0003L H2O
140 \u0003µL
+ 5 \u0003µL H2O
140 µL
+ 5 \u0003µL H2O
Sample25 µL2 \u0003µL
+ 20 µ\u0003L H2O
2 \u0003µL
+ 20 µ\u0003L H2O
DIL1 (ACCB)30 µ\u0003L--
SR5 \u0003µL
+ 25 µ\u0003L H2O
5 µ\u0003L
+ 5 µ\u0003L H2O
5 µ\u0003L
+ 5 µL H2O
Total volume190 µL177 µL177 µL

Calibration
Calibrator                   Calibrator A Bio (CAL A, 599)
Calibration mode        Logit/log 5
Calibration replicate   Duplicate recommended
Calibration intervall    Each new lot, and if recalibration is required due to QC results

Quality control
Controls
  • Control A Level 2 Bio (CONA2, 112)
  • Control A Level 3 Bio (CONA3, 113)
Use the recommended control material. Other suitable control material can be used in addition.
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 % Bio' 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.
Intervals / limits:
           Control intervals and acceptance limits should be adapted to each laboratory's individual requirements.
If values do not fall into 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.
 ", "Name": "Protocols - Help Corner" }, { "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.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Immunoturbidimetric
Recovery: ±10%", "Name": "Specification" } ] } } ] }

IgG Bio

Test kit for the Cedex Bio Analyzer

Cedex IgG

Overview

Ordering

Technical documents

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