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EXENT® GAM Assay

The Immunoglobulin Isotypes (GAM) for the EXENT® Analyser (EXENT® GAM Assay) aids in confirmatory diagnosis and monitoring of monoclonal gammopathies

Overview

What is the EXENT GAM Assay?

The EXENT GAM Assay is a sensitive and specific immunoassay that identifies and quantifies M-proteins based on their unique molecular mass. Sample preparation uses paramagnetic beads specific to human IgG, IgA, IgM, total Kappa and total Lambda to isolate immunoglobulins from patient serum. The isolated immunoglobulins are analysed by MALDI-ToF mass spectrometry to specifically measure the monoclonal protein component. The assay is used in conjunction with the Binding Site Optilite® IgG, IgA and IgM assays to enable quantification of the identified monoclonal proteins.​

A new paradigm for the detection & quantification of M-proteins

   
(A) When immunoglobulins are isolated from the serum of a healthy individual, by specific immunopurification, the resulting MALDI-ToF mass spectrometry resolves three normally distributed peaks that are representative of the polyclonal Lambda, Kappa and heavy Kappa free light chains derived from the intact immunoglobulins.1                         
   
(B) In a patient with a monoclonal gammopathy, the presence of a sharp peak within the polyclonal background is indicative of the presence of a monoclonal immunoglobulin. The molecular weight of the identified peak can be used to specifically track the monoclonal protein and the peak area ratio of the monoclonal to polyclonal can be combined with the Optilite IgG, IgA or IgM assay to derive a quantification.                     

When a monoclonal protein is identified, a simple calculation is applied to provide quantification based on the total immunoglobulin value derived from the Optilite IgG, IgA or IgM assay. ​

How can the EXENT GAM Assay be used?​

Can aid the diagnosis of monoclonal gammopathies i.e:​

  • MGUS (Monoclonal Gammopathy of Undetermined Significance)​ 
  • SMM (Smoldering Multiple Myeloma)​ 
  • MM (Multiple Myeloma)​ 
  • Waldenström’s Macroglobulinemia​ 
  • AL Amyloidosis

Can aid the monitoring of:​

  • MM (Multiple Myeloma)​
  • Waldenström’s Macroglobulinemia​

EXENT System Assay Menu

Description Product Code    
Immunoglobulin Isotypes (GAM) for the EXENT Analyser  MSR801.M​
EXENT System
Instruments
EXENT System
The EXENT System is an automated solution that enables M-protein identification and measurement in serum with enhanced sensitivity beyond conventional methods
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Instruments
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The Optilite Analyser utilizes proven turbidimetric technology, which is known to be fast, robust and versatile, becoming the main technology for protein diagnostics worldwide
Product availability is subject to country specific regulatory requirements. Contact your local representative for availability in your country.
This product is not commercially available in the USA or China. Future commercial availability cannot be guaranteed.
EXENT and Optilite are registered trademarks of The Binding Site Group Limited (Birmingham, UK) in certain countries.
The EXENT® System combines EXENT® Analyser with Immunoglobulin Isotypes (GAM) for the EXENT® Analyser.
EXENT GAM Assay refers to Immunoglobulin Isotypes (GAM) for the EXENT® Analyser.
 
The EXENT® System consists of the following CE marked products:
  • EXENT Analyser, IE800 (IVDR Class A, nonsterile);
  • Immunoglobulin isotypes (GAM) for the EXENT Analyser - MSR801.M (IVDR Class C),
  • EXENT Immunoglobulin Isotypes (GAM) Control Pack - MSQ801.M (IVDR Class C).
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References
  1. Barnidge DR, et al. Subset of kappa and lambda germline sequences result in light chains with a higher molecular mass phenotype. J Proteome Res 2015; 14:5283-90