Introduction

What are subclass assays?

For your laboratory's immunoglobulin (Ig) subclass testing needs, we offer a comprehensive range of tests. Additionally, we are proud to be the exclusive provider of an automated turbidimetric method for IgA 1-2.

There are four different IgG subclasses. The most obvious differences between the subclasses can be seen in the hinge regions, where for instance IgG1 has a short hinge region and IgG3 has a longer hinge region. 

These differences add up to partially explain why the individual subclass have slightly different functions and properties. IgG1 and IgG3 are strong mediators of both FcγR and complement-mediated functions, and are the predominant subclasses involved in the response to protein antigens. IgG2 is a weak mediator of FcγR and complement-mediated functions and is involved in the response to polysaccharide antigens. IgG4 has a minimal ability to activate effector cells or fix complement.

The reference material reflects the true biological distribution of the IgG1,2 (IgG1>IgG2>IgG3>IgG4)

Immunoglobulin immunoassays
Detect and quanitify immunoglobulins accurately to evaluate and diagnose humoral immune response and disorders

Ig subclass assays aid in the characterization of many immunodeficiency diseases including hypogammaglobulinaemia, hypergammaglobulinaemia.

Together with other tests, it provides a holistic view of the patient’s immune status

What is this test?

IgG subclass

  • Our IgG subclass calibration is traceable to the internationally recognised reference material ERM-DA470k, which is accepted by the International Federation of Clinical Chemistry (IFCC)
  • Our automated and optimized IgG subclass assays provide: 
    • Quantifiable test results for timely clinical decisions 
    • Full traceability for quality assurance boosting confidence in test results The reference material reflects the true biological distribution of the IgG1,2 (IgG1>IgG2>IgG3>IgG4)

*There is currently no consensus on what calibration material to use for measuring IgG subclasses. The Binding Site used CRM 470, which has now been replaced by ERM-DA470k due to stock depletion. The calibration used in The Binding Site IgG subclasses assays is internationally recognized and accepted by the International Federation of Clinical Chemists (IFCC), as it reflects the subclass biological distribution (IgG1>IgG2>IgG3>IgG4)

IgA subclasses Introduction

IgA Subclass

There are two different IgA subclasses. IgA is responsible for mucosal immunity and is therefore the first line of defence for the majority of infections. Normal serum concentrations of both IgA subclasses may be very low therefore a sensitive, reproducible assay is essential.

IgA subclass testing allows the laboratory to detect global changes in the production or stability of the IgA subclasses. Obtaining these results, together with other test results, allows for a more complete picture of the patient’s condition, and more detailed overall clinical picture.

Your laboratory's immunoglobulin subclass testing requirements are fully covered with our comprehensive range of tests. Notably, we offer the exclusive automated turbdimetric method for IgA 1-2.

Our automated and optimized IgA Subclass assays provide: 

  • Quantifiable test results for timely clinical decisions
  • Full traceability for quality assurance, boosting confidence in test results 
  • The reference material reflects the true biological distribution of the IgA2 subclasses: (IgA1 (85%) > IgA2 (15%). In secretions IgA2 can dominate, the exact ratio varies between location)

Assays on other instruments

Description Product Code Kit Size
Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BN ProSpec™ NK006.P 4 x 40 test
Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BN ProSpec™ NK007.P 4 x 40 test
Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BN ProSpec™ NK008.P 4 x 40 test
Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BN ProSpec™ NK009.P 4 x 40 test
Description Product Code Kit Size
Human IgG1 Subclass Liquid Reagent Kit for use on the Siemens BNII™  NK006.TB 4 x 40 test
Human IgG2 Subclass Liquid Reagent Kit for use on the Siemens BNII™   NK007.TB 4 x 40 test
Human IgG3 Subclass Liquid Reagent Kit for use on the Siemens BNII™   NK008.TB 4 x 40 test
Human IgG4 Subclass Liquid Reagent Kit for use on the Siemens BNII™   NK009.TB  4 x 40 test
Description Product Code Kit Size
Human IgG1 Subclass Liquid Reagent Kit for use on the Roche Cobas 6000™ NK006.CB 100 test
Human IgG2 Subclass Liquid Reagent Kit for use on the Roche Cobas 6000™ NK007.CB 100 test
Human IgG3 Subclass Liquid Reagent Kit for use on the Roche Cobas 6000™ NK008.CB 100 test
Human IgG4 Subclass Liquid Reagent Kit for use on the Roche Cobas 6000™ NK009.CB  100 test

 

 
BN ProSpec and BNII are trademarks of Siemens Healthcare Diagnostics Inc.
Cobas is a trademark of Roche, Basel, Switzerland.

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References
1. Wilson et al. 2013. Significant, quantifiable differences exist between IgG subclass standards WHO67/97 and ERM-DA470k and can result in different interpretation of results, Clin Biochem.
2. Schauer 2003, IgG Subclass Concentrations in Certified Reference Material 470 and Reference Values for Children and Adults Determined with The Binding Site Reagents, Clin Chem. 2003; 49:1924-9