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Internal Control to Remove Background in Multiplex Immunoassays

The US Army Research Institute of Infectious Diseases has developed a method to eliminate immunoassay inconsistency due to background effects. Immunological-based assays, such as ELISA (planar) or bead-based, suspension microsphere assays, are plagued with background issues. Almost all clinical and environmental samples will generate a background signal, and this signal can vary tremendously from sample to sample. These background effects greatly reduce the sensitivity of multiplexed immunoassays. It is very difficult to identify a sample positive for a target antigen when presented in the background of a variety of negative sample effects. This is particularly a concern when detecting samples with small amounts of antigen.

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The Technology: 

Current attempts to correct for background effects include adding blocking agents that are expensive and/or running multiple negative controls for each sample that can be prohibitive as the number of multiplexed assays increase. The inexpensive Army technology does not require such measures and is more effective at removing background.

Benefits: 

• Increased sensitivity: Can significantly decrease the lower limit of detection
• Decreased variability: %CoV < 10% can be achieved using a population of samples containing equivalent concentrations of target
• Simple: Requires no or minimal changes to previously developed assays
• Low cost: Avoids the usage of many additional reagents and does not use expensive blocking agents
• Multiple applications: Can be applied to immunoassays used in many industries such as human diagnostics, veterinary diagnostics as well as environmental testing applications

The Opportunity: 

• A pending US patent application is available for license
• Potential for collaboration with the US Army Research Institute of Infectious Diseases
Additional information available at techlinkcenter.org/ internal control immunoassay

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