Immune ResponseThe 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. |
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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.
- Wood P. Primary antibody deficiency syndromes. Ann Clin Biochem 2009; 46:99-108
- Bonilla FA, et al. Practice parameter for the diagnosis and management of primary immunodeficiency. Ann Allergy Asthma Immunol 2005; 94:S1-63
- Aghamohammadi A, et al. Predominantly Antibody Deficiencies. Primary immunodeficiency diseases 2008; 5:97-130
- 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
- Vladutiu AO. Immunoglobulin D: properties, measurement, and clinical relevance. Clin Diagn Lab Immunol 2007; 2:131-140
- 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.








