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"System reagent for the Cedex Bio Analyzer", "ReferenceType": "Auxilliary", "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.", "Country": "XG", "Code": "Storage Conditions (Working Solution)", "Name": "Storage Conditions (Working Solution)" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Country": "XG", "Code": "CB - Order Information", "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 ", "Country": "XG", "Code": "Background Information - Help Corner", "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.", "Country": "XG", "Code": "Troubleshooting - Help Corner", "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.", "Country": "XG", "Code": "Product Description", "Name": "Product Description" }, { "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": "
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 DIL1white2 vials,
100 tests
each
Diluent (DIL1): Accelerator for sensitive IgG detection; polyethylene glycol, 1%; sodium chloride, 0.9%; preservative.
", "Country": "XG", "Code": "Content", "Name": "Content" }, { "Language": "en", "Value": "
Analyzer and accessories
  • Cedex Bio Analyzer*, including accessories and disposables
  • NaCl Diluent 9% Bio* (ACN 951)
  • Cleaner Alkaline Bio* (ACN 947)
  • Standard laboratory equipment
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\".
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": "Method: Immunoturbidimetric
Recovery: ±10%", "Country": "XG", "Code": "Specification", "Name": "Specification" }, { "Language": "en", "Value": "This product is intended for quantitative determination of human Immunoglobulin G (IgG) in aqueous solutions using the Cedex Bio Analyzer*.", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" }, { "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 test definition
Test definitionIGGLB
(923)
IGGHB
(926)
IGGHD
(908)
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 mg/L
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/last7/167/167/16
Antigen access checkYes (SR)Yes (SR)Yes (SR)
Unitµmol/L, mg/Lµmol/L, mg/Lµmol/L, mg/L
Pipetting parameters
Pipetting parametersIGGLB(1)
(923)
IGGHB
(926)
IGGHD
(908)
NaCl Diluent 0.9% Bio (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
Sample (S)25 µL2 μL + 20 μL water2 μL + 20 μL water
DIL1 (ACCB)30 µLNoNo
SR5 µL + 25 µL water5 μL + 5 μL water5 μL + 5 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, 599)
Calibration modeLogit/Log5
Calibration replicateDuplicate recommended
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 the 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.
Protocol IGGHB and IGGHD
  • Control A Level 2 Bio (CONA2, 112)
  • Control A Level 3 Bio (CONA3, 113)

Use the recommended control material. Other suitable control material can also be used.
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.
Extra wash cycle
In order to prevent any potential influence by carryover 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.
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 type 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 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
Mean3.90 µmol/L (585 mg/L)6.67 µmol/L (1.001 mg/L)
CV in-run [%]0.60.8
CV inter-run [%]0.91.7
Test protocol barcodes
IgG Low Range Bio with Extra Wash Cycle, IGGLB (923) v02Fig. 1: LightCycler® 8-Tube Strip Adapter Plate on top of a second LightCycler® 8-Tube Strip Adapter Plate.IgG High Range Bio, IGGHB (926) v03Fig. 2: LightCycler® 8-Tube Strip Adapter Plate on top of a standard multiwell plate 96 (MWP).IgG High Range Bio with Dilution, IGGHD (908) v04", "Country": "XG", "Code": "Protocols", "Name": "Protocols" } ] } } ] }

IgG Bio

Test kit for the Cedex Bio Analyzer

Cedex IgG

Ordering Information

Technical documents

for certificates, method sheets (instructions for use), safety data sheets and software downloads
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