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Measuring range

Mouse IgG concentration can be determined in the following ranges:
  • MIGLB: 10 to 200 mg/L
  • MIGHB: 200 to 1500 mg/L
  • MIGHD: 1000 to 7500 mg/L
Traceability
This method has been standardized against net weight of a typical Mouse IgG of subtype IgG1 with a molecular mass of about 160 kDa.
Precision
Representative performance data on Cedex Bio 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 10 days).

 Level 1  Level 2Level 3
Mean68 mg/L476 mg/L939 mg/L
CV in-run2.1%1.6%0.9%
CV inter-run1.2% 1.0%1.2%
", "Name": "Background Information - Help Corner" }, { "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)
  • Calibrator F Bio*
  • Control F Level 1 Bio*
  • Control F Level 2 Bio*
  • Control F 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 Mouse IgG protocols even if no dilution is ordered.
", "Name": "Additional Equipment and Reagent Required" }, { "Language": "en", "Value": "
VialCapContentComposition
1 MIGB R1white4 vials,
50 tests each
Reagent 1 (R1): Sodium chloride, 150 mmol/L; polyethylene glycol, 7%; TRIS, 50 mmol/L; preservative; pH 8.0.
2 MIGB SRblack4 vials,
50 tests each
Start Reagent (SR): Anti-IgG antiserum (sheep) specific for mouse IgG; sodium chloride, 150 mmol/L; TRIS, 50 mmol/L; preservative; pH 8.0.
", "Name": "Content" }, { "Language": "en", "Value": "Unit of measure is \"piece\".", "Name": "CB - Order Information" }, { "Language": "en", "Value": "Test protocols
Mouse IgG concentrations can be determined in the ranges shown in the table below, depending on the selected test protocol.
If a test result is flagged with the remark \"<Test Rng\" or \">Test Rng\", repeat the analysis of the sample using the appropriate test protocol.
IgG concentrations high above the valid test ranges may cause a prozone (hook) effect in the test, resulting in low signals that may lead to false low values without the flag \">Test Rng\". See table below for subclass IgG1 concentrations that may trigger a prozone effect.
Test definitionMIGLB (080)MIGHB (078)MIGHD (079)
Measuring rangeLow range
10 - 200 mg/L
High range
200 - 1500 mg/L
High range with dilution
1000 - 7500 mg/L
Measuring modeAbsorbanceAbsorbanceAbsorbance
Abs. calculation modeEndpointEndpointEndpoint
PredilutionNoNo1 : 5
ReactionmodeR1-S-SRR1-S-SRR1-S-SR
Reaction directionIncreaseIncreaseIncrease
Wavelength340 nm340 nm340 nm
Calculationfirst/last11/3011/3011/30
Displayed unitmg/Lmg/Lmg/L
Potential prozone effect (IgG1)> 6g/L> 10 g/L> 50 g/L

Pipetting parametersIGGLB (923)IGGHB (926)IGGHD (908)
R1125 µL125 µL125 µL
Sample15 µL
+ 15 µL H2O
4 µL
+ 16 µL H2O
4 µL
+ 16 µL H2O
SR50 µL75 µL75 µL
Total volume205 µL220 µL220 µL

Calibration
Calibrator Calibrator F Bio (CAL F, 301)
Calibration mode Logit/Log 5
Calibration interval 98 days, and if recalibration is required due to QC results
The antiserum in this kit enables detection of Mouse IgG subclassesIgG1, IgG2a and IgG2b. Nevertheless, the calibrator CAL F
is optimized for accurate test calibration for determination of IgG1.The affinity of the antiserum may be slightly different for other subclasses(IgG2a, IgG2b). Therefore, results for the other subclassesmay be less accurate. For optimal accuracy of the results for subclassesother than IgG1, use the specific IgG product for calibration.
Prepare a solution of the individual IgG product with anexactly defined concentration in the range of 1200 to 1500 mg/Land use this as a calibrator instead of CAL F. The threshold of theprozone effect for other subclasses than IgG1 (see table chaptertest protocols) may differ.
Quality control
MIGLB: Control F Level 1 Bio (CONF1, 302)
MIGHB: Control F Level 2 Bio (CONF2, 303)
Control F Level 3 Bio (CONF3, 304)
MIGHD: Use custom controls in the range of1250 - 6500 mg/L IgG(Control F Levels 1, 2 and 3 are belowthe range).

Use the recommended controls if the test is calibrated using CAL F.
With a custom IgG calibration, use the same IgG for generating controls.
Control intervals and acceptance limits should be adapted to each laboratory'sindividual requirements. If values do not fall into the definedlimits, corrective measures and recalibration are required.", "Name": "Protocols - Help Corner" }, { "Language": "en", "Value": "Monoclonal Mouse IgG antibodies are commonly used for specific detection of protein targets in research, in vitro diagnostics (IVD), and in early phase pharmaceutical development of therapeutic antibodies. In the production of recombinant Mouse IgG antibodies, there is the need for determination of the IgG concentration during the production process. The Cedex test kit enables automated determination of Mouse IgG with high precision, short time to result, and high convenience.", "Name": "Applications" }, { "Language": "en", "Value": "Method: Immunturbidimetric
Recovery: ± 15%", "Name": "Specification" } ] } } ] }

Mouse IgG Bio

Test kit for the Cedex Bio Analyzer

Cedex Mouse IgG

Overview

Ordering

Technical documents

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