{ "ProductData": { "RelatedLinks": "", "RegulatoryDisclaimer1": "For use in quality control / manufacturing process only.", "RegulatoryDisclaimer2": "", "StainLocalization": [ "" ], "DisclaimerGroup2": null, "ProductNameGlobal": "IgG Bio HT", "DisclaimerGroup1": "", "ControlTissue": [ "" ], "BrandName": "IgG Bio HT", "LicenseDisclaimers": [ ], "Isotypes": "", "RegulatoryDisclaimer3": "", "ID": "3.8.10.3.4.7", "ProductNameAddition": "Test kit for the Cedex Bio HT Analyzer", "Species": [ "" ], "Clone": "" }, "ProductSpec": { "ProductSpecVariant": { "Chapters": [ { "Language": "English", "Value": "
On-board stability: After first use on the analyzer, the kit is stable for up to 12 weeks on board.", "Name": "Storage Conditions (Working Solution)" }, { "Language": "English", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "English", "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.", "Name": "Troubleshooting - Help Corner" }, { "Language": "English", "Value": "Conversion Factors
\nConversion factors for IgG concentration:
\n• 1 mmol/L = 150.0 g/L
\n• 1 g/L = 6.67 μmol/L
\n(typical value for human IgG, molecular weight may vary depending on source of IgG and glycosylation grade).
\nTraceability
\nThis method has been standardized against net weight of a reference material of subtype IgG1.
\nPrecision
\nRepresentative 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.
\nCoefficients of variation (CV) were calculated for in-run precision (n=21) and inter-run precision (on 10 days).\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 1	Level 2
Mean	3.80 \u0003mol/L (570 mg/L)	6.95 \u0003mol/L (1043 mg/L)
CV in-run	0.7 %	0.6 %
CV inter-run	1.5 %	1.2 %

\n
\n
\n
\n ", "Name": "Background Information - Help Corner" }, { "Language": "English", "Value": "Method: Immunoturbidimetric
Recovery: ±10%", "Name": "CB - Specification" }, { "Language": "English", "Value": "This product is intended for quantitative determination of human Immunoglobulin G (IgG) in aqueous solutions using the Cedex Bio HT Analyzer.", "Name": "Product Description" }, { "Language": "English", "Value": "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": "English", "Value": "

Vial	Content	Composition
IGGB	Reagent 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.

", "Name": "Content" }, { "Language": "English", "Value": "

• Cedex Bio HT Analyzer*, including accessories and disposables
• Standard laboratory equipment

• NaCl Diluent 9%*
• Accelerator*
• Cleaner Alkaline Bio HT*
• Calibrator A Bio*
• Activator Bio*
• Control A Level 2 Bio*
• Control A Level 3 Bio*

", "Name": "Additional Equipment and Reagent Required" }, { "Language": "English", "Value": "Test protocols
IgG concentrations can be determined in following ranges depending on the selected test protocol, 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.

Test definition	IGGLB (919)	IGGHB (926)	IGGHD (722)
Range	Low range 10 - 80 mg/L 0.067 - 0.533 μmol/L	High range 80 - 1600 mg/L 0.53 - 10.7 µmol/L	High + dilution 0.4 - 8 g/L 2.7 - 53.4 μmol/L
Measuring mode	Absorbance	Absorbance	Absorbance
Abs. calculation mode	Endpoint	Endpoint	Endpoint
Extra wash cycle (EWC)	Yes	No	No
Sample Predilution	No	No	1:5
Reaction mode	R1-DL-S-SR	R1-S-SR	R1-S-SR
Reaction direction	Increase	Increase	Increase
Wavelength A/B	340/652 nm	340 nm	340 nm
Calculation first/last	18/33	18/33	18/33
Antigen access check	Yes (R2)	Yes (R2)	Yes (R2)
Displayed unit	µmol/L, mg/L	µmol/L, mg/L	µmol/L, mg/L

Pipetting parameters	IGGLB (919)	IGGHB (926)	IGGHD (722)
Cleaner Alkaline (EWC)	100 µL	-	-
NaCl Diluent 9%	-	-	1:5
R1	100 µL + 5 µL H2O	140 µL + 5 µL H2O	140 μL + 5 μL H2O
Accelerator	30 µL	-	-
Sample	25 µL	2 µL + 20 µL H2O	2 μL + 20 μL H2O
SR	5 µL + 25 µL H2O	5 µL + 5 µL H2O	5 μL + 25 μL H2O
Total volume	190 µL	177 µL	177 μL

Calibration
Calibrator                   Calibrator A Bio (CAL A, 07-1100-4)
Calibration mode        Logit/log 5
Calibration intervall    Each new lot, and if recalibration is required due to QC results

Quality control
Controls

• 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 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 % with water. The IgG concentration of the original control level 2 has to be divided by 10 for entering the lotspecific 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 (EWC) with the alkaline cleaner for the pipetting device.", "Name": "Protocols - Help Corner" }, { "Language": "English", "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": "English", "Value": "Kit for determination of human IgG.", "Name": "Positioning" }, { "Language": "English", "Value": "Method: Immunoturbidimetric
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