IgG Subclass 1–4 Immunoassays
The Comprehensive Solution for IgG Determination

IgG Subclass 1–4 Immunoassays
 
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IgG Subclass 1–4 Immunoassays

IgG Subclass 1–4 Immunoassays

The determination of IgG subclass concentrations is indicated for diagnostic clarification in patients with increased susceptibility to infection, malfunctioning immune defense systems, and abnormally frequent and/or prolonged or severe infections that cannot be explained by standard clinical and laboratory data. Siemens Healthineers solution for IgG determination combines high precision with the trusted performance of the BN™ Systems for a comprehensive solution you can rely on.

  • Comprehensive solution for IgG determination from one source
  • Optimally aligned innovative assays and analyzers
  • Assay protocols with pre-reaction for antigen-excess security
  • The ability to measure all four subclasses provides insight into deficiencies that may be masked in a total IgG measurement or predominant IgG1.

Características y Beneficios

Comprehensive solution for IgG determination from one source

  • Obtain reagents, supplementary reagents, analyzers, and service from one source
  • Reduce costs through a highly flexible and reagent-independent packaging concept: All components can be ordered separately, which helps to minimize waste and ensure supply of standard and controls.

Antigen-excess security for more accurate results

  • Feel more confident through detection of high-dose hook effects.
  • Improve cost-effectiveness due to fewer retests.

Precise results you can trust

  • Because IgG3 and IgG4 levels can dramatically rise in affected patients, a special cleaner solution is used to prevent carryover into the next sample measurement.

Uso Clínico

Deficiencies of IgG subclasses are an indication of a disturbed immune response and usually lead to clinical symptoms in the patient, although decreased levels of IgG subclasses may also be asymptomatic. However, several disease states are strongly associated with decreased or increased levels of IgG subclasses. Measuring total IgG may only mask deficiencies in subclasses 2, 3, and/or 4 due to a possible high concentration of predominant IgG1.

Therefore, the determination of IgG subclass concentrations has become increasingly important in clinical diagnostics. It is indicated for diagnostic clarification in patients with:

  • A malfunctioning immune defense
  • Immunoglobulin deficiencies
  • Increased susceptibility to infection
  • Abnormally frequent and/or prolonged or severe infections that cannot be explained by standard clinical and laboratory data

IgG4-related disease is a relatively new and growing entity of immune-mediated origin, often with multi-organ impairment. Although the diagnosis of this disease must be confirmed histopathologically, serum IgG4 is an important marker in the evaluation and longitudinal assessment. Diagnostic delays in the setting of IgG4-related disease can lead to cirrhosis, pancreatic failure, advanced renal dysfunction, and many other complications.

Therapy with glucocorticoids is considered a first choice with very good patient outcomes. If this therapy is used, it should be monitored over a certain period (12 months recommended by guidelines) by measuring serum IgG4 for evaluation of treatment or detection of relapse.

Detalles Técnicos


Assay characteristics

 N Antiserum IgG/Subclass 1N Antiserum IgG/Subclass 2N Latex IgG3N Latex IgG4
Assay principleLatex-enhanced immunonephelometry
Sample
types
Human serum, EDTA plasma, heparinized plasma
Reference ranges14.05 – 10.111.69 – 7.860.11 – 0.850.03 – 2.01
Initial measuring range0.85 - 270.35 - 110.033 - 2.10.052 - 3.3
Measuring time6122+6
incl. pre-reaction
2+6
incl. pre-reaction
Once-opened reagent stability2 weeks on BN ProSpec® System, 3 days (6 days with evaporation stoppers) on BN™ II System2 weeks on BN ProSpec® System, 3 days (6 days with evaporation stoppers) on BN™ II System2 weeks on BN ProSpec® System, 5 days (10 days with evaporation stoppers) on BN™ II System2 weeks on BN ProSpec® System, 5 days (10 days with evaporation stoppers) on BN™ II System
Calibration frequency4 weeks4 weeks4 weeks4 weeks
Precision
(total CV)
≤ 3% @ 3.6 g/L< 3.0% @ 1.8 g/L≤ 6% @ 0.84 g/L< 3% @ 0.507 g/L

 


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1. The above reference ranges (2.5th to 97.5th percentile in g/L) were established by testing samples from 279 apparently healthy adults from Central Europe (data on file). Please refer to the download section for pediatric reference ranges.