Immunoglobulins and Subclasses

Immune Response

The immune system is composed of a variety of different cell types and proteins, each performing a special task aimed at recognizing and/or reacting with a foreign material such as bacteria, viruses, pollen and transplanted organs from other individuals.  When part of the immune system is absent or its function is impaired, an immunodeficiency may occur. 
Binding Site offers Immunoglobulin and IgG and IgA subclass immunoassays on many different platforms:

 

 

IgG, IgA and IgM concentrations can be measured reliably by a wide range of laboratory assays and are a useful screening method for the detection of agammaglobulinemia and hypogammaglobulinemia. The quantitation of IgD in serum samples is an important part in the diagnosis and monitoring of PID. 

SPAplus

Description Pack Code
IgG SPAplus kit 100 test NK004.S
IgA SPAplus kit 100 test NK010.S
IgM SPAplus kit 100 test NK012.S
IgD SPAplus kit 100 test LK013.S

 MININEPH

Description Pack Code
IgG MININEPH kit 50 test ZK004.R
IgG-LL MININEPH kit* 50 test ZK004.LL
IgA MININEPH kit 50 test ZK010.R
IgM MININEPH kit 50 test ZK012.R

  * Research use only 

 

 Siemens BN™II

Description Pack Code
IgD BN™II Latex kit 2 x 50 test LK013.T

 Radial Immunodiffusion

Description Pack Code
IgG RID kit - NL 3 plate kit RN004.3
IgG RID kit - ML* 3 plate kit RL004.3
IgG kit - UL* 3 plate kit GL004.3
IgM RID kit - NL 3 plate kit RN012.3
IgM kit - ML* 3 plate kit GM012.3
IgM kit - UL* 3 plate kit GL012.3
IgG, IgA, IgM COMBI RID kit - NL 3 plate kit RK002
IgA RID kit - NL 3 plate kit RN010.3
IgA RID kit - ML* 3 plate kit RL010.3
IgA RID kit - UL* 3 plate kit GL010.3
Secretory IgA RID kit - NL* 3 plate kit RN148.3
IgD RID kit - NL 3 plate kit RN013.3
 

 *Research Use Only

 

When developing assays to measure IgG subclasses, Binding Site has considered all the factors necessary to ensure that the assays will meet clinical requirements in terms of:

Sensitivity - The IgG3 and IgG4 assays utilize latex-enhanced liquid stable reagents especially useful in pediatric samples

Specificity - Patented technology for manufacturing highly specific, affinity purified, polyclonal antisera.

Standardization - Calibrated against the International Reference Material DA470k. For more information see below.

Binding Site IgG subclass assays are available on many platforms and methods including, SPAPLUS, BN™II, Immage©, Roche/Hitachi, RID, and MININEPH™. 

 

SPAPLUS

 Description  Pack  Code
IgG1 SPAPLUS kit 100 test NK006.S
IgG2 SPAPLUS kit 100 test NK007.S
IgG3 SPAPLUS Latex kit 100 test LK008.S
IgG4 SPAPLUS Latex kit 100 test LK009.S
IgG SPAPLUS kit 100 test NK004.S

 

Siemens BN™II 

Siemens BN™II subclass kits are available in two different configurations (measuring ranges) and have been formulated in latex and non-latex reagents to meet your sensitivity needs. In order to run Binding Site reagents on the Siemens BNII it is necessary to open specific channels on the analyzer and this may require the assistance of a Siemens engineer.

Please contact us for further information. An alternative to the pre-programmed protocol must be selected to run the following assays. Full details are provided in the product inserts.
 
 

 Description  Pack  Code
BN™II Latex COMBI kit
(Latex IgG3 & IgG4, non-latex IgG1 & IgG2)
2 x 48 test
2 x 40 test
LK001.TB 
IgG1 BN™II kit 4 x 40 test NK006.TB
IgG2 BN™II kit 4 x 40 test NK007.TB
IgG3 BN™II Latex kit 4 x 48 test LK008.TB
IgG4 BN™II Latex kit 4 x 48 test LK009.TB

   

Description
Pack
Code
BN™II COMBI kit
(IgG1, IgG2, IgG3, IgG4)
4 x 40 test
NK001.T
IgG1 BN™II kit
4 x 40 test
NK006.T
IgG2 BN™II kit
4 x 40 test
NK007.T
IgG3 BN™II kit
4 x 40 test
NK008.T
IgG4 BN™II kit
4 x 40 test
NK009.T

 Beckman Coulter Analyzers

These kits require the user to set up a user-defined reagent (UDR) for each assay.

Description
Pack
Code
IgG1 IMMAGE® kit
58 test
NK006.IM
IgG2 IMMAGE® kit
58 test
NK007.IM
IgG3 IMMAGE® Latex kit
58 test
LK008.IM
IgG4 IMMAGE® Latex kit
58 test
LK009.IM
IgG1 AU® kit
100 test
NK006.AU
IgG2 AU® kit
100 test
NK007.AU
IgG3 AU® Latex kit
100 test
LK008.AU
IgG4 AU® Latex kit
100 test
LK009.AU

 Roche/Hitachi Analyzers

The IgG subclass kits below have been developed for use on the following Roche/Hitachi Modular P, Hitachi 911, Hitachi 912 and Hitachi 917 analyzers.

Description
Pack Code
Hitachi COMBI kit (Latex IgG3 & IgG4, non-latex IgG1, IgG2 & IgG) 5 x 45 test LK001.H
IgG1 Hitachi kit 4 x 45 test NK006.H
IgG2 Hitachi kit 4 x 45 test NK007.H
IgG3 Latex Hitachi kit 4 x 45 test LK008.H
IgG4 Latex Hitachi kit 4 x 45 test LK009.H

 

Radial Immunodiffusion (RID)

 Description
 Pack
 Code
IgG Subclass COMBI kit – SD
(one plate each of IgG1, IgG2, IgG3, IgG4)
4 plate kit
RK021
IgG1 Subclass – SD+
3 plate kit
RN106.3
IgG2 Subclass – SD+
3 plate kit
RN107.3
IgG3 Subclass – SD
3 plate kit
RN108.3
IgG4 Subclass – SD
3 plate kit
RN109.3

+Diluted sample applied – assay range may be extended using neat sample.

 

MININEPH™

Description
Pack
Code
IgG1 MININEPH™ kit 10 tests ZK006.R
IgG2 MININEPH™ kit 10 tests ZK007.R
IgG3 MININEPH™ Latex kit 2 x 5 tests ZK008.L.R
IgG4 MININEPH™ Latex kit 2 x 5 tests ZK009.L.R

 

Normal serum concentrations of both IgA subclasses may be very low; therefore a sensitive, reproducible assay is essential, particularly for pediatric samples. Binding Site IgA subclass assays utilize highly specific high affinity, polyclonal antisera and latex-enhanced reagents to enable accurate quantitation to very low levels.

These immunoassays are available on several platforms including SPAPLUS, BN™II  and RID.

SPAPLUS 

Description
 Pack  Code
IgA1 SPAplus kit 50 test NK087.S
IgA2 SPAplus kit 50 test LK088.S

Instructions on how to set up these protocols are provided in the product inserts. 

 Description  Pack  Code
IgA1 BN™II kit 40 test NK087.1T
IgA2 BN™II  Latex kit 40 test LK088.1T
IgA subclass BN™II COMBI kit (Latex IgA2, non-latex IgA1) 2 x 40 test LK003.T

Radial Immunodiffusion (RID)

This IgA subclass RID kit has been developed for the quantitation of IgA subclasses in human serum and cerebrospinal fluid.
 

Description
Pack Code
IgA subclass COMBI kit - NL (two plates each of IgA1 and IgA2) For serum and CSF 4 plate kit RK015

 

Calibration of an assay against an internationally recognized reference preparation ensures that sample results remain accurate and consistent.

A new international reference material, ERM®-DA470k/IFCC (DA470k; Institute for Reference Materials and Management) has been produced and all of the Binding Site immunoglobulin assays are now calibrated to this reference material. This reference material is equivalent to the CRM470 and Binding Site assays have been shown to give accurate results when evaluated against this material.

  1. Wood P. Primary antibody deficiency syndromes. Ann Clin Biochem 2009; 46:99-108
  2. Bonilla FA, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol 2005; 94:S1-63
  3. Aghamohammadi A, et al. Predominantly Antibody Deficiencies. Primary immunodeficiency diseases 2008; 5:97-130 
  4. De Vries E. Patient-centred screening for primary immunodeficiency: a multi-stage diagnostic protocol designed for non-immunologists. Clin Exp Immunol 2006; 145:204-214
  5. Vladutiu AO. Immunoglobulin D: properties, measurement, and clinical relevance. Clin Diagn Lab Immunol 2007; 2:131-140
  6. Williams DR, et al. Assignment of IgG Subclass Values to the Protein Reference Preparation DA470k. Clin Chem 2009; 55 Supplement:A132

BN™II is a trademark of Siemens Healthcare Diagnostics Inc.
IMMAGE® and AUTM are registered trademarks of Beckman-Coulter Instruments Inc.
MININEPH™ and IMMPROVE™ are trademarks of The Binding Site Group Ltd, Birmingham, UK.