IgG Subclass 1–4 Immunoassays

The Comprehensive Solution for IgG Determination

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.
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Features & Benefits

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.

Clinical Use

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.

Technical Details


 

N Antiserum IgG/Subclass 1

N Antiserum IgG/Subclass 2

N Latex IgG3

N Latex IgG4

Assay principle

Latex-enhanced immunonephelometry

Sample
types

Human serum, EDTA plasma, heparinized plasma

Reference ranges1

4.05 – 10.11

1.69 – 7.86

0.11 – 0.85

0.03 – 2.01

Initial measuring range

0.85 - 27

0.35 - 11

0.033 - 2.1

0.052 - 3.3

Measuring time

6

12

2+6
incl. pre-reaction

2+6
incl. pre-reaction

Once-opened reagent stability

2 weeks on BN ProSpec® System, 3 days (6 days with evaporation stoppers) on BN™ II System

2 weeks on BN ProSpec® System, 3 days (6 days with evaporation stoppers) on BN™ II System

2 weeks on BN ProSpec® System, 5 days (10 days with evaporation stoppers) on BN™ II System

2 weeks on BN ProSpec® System, 5 days (10 days with evaporation stoppers) on BN™ II System

Calibration frequency

4 weeks

4 weeks

4 weeks

4 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