Multiplexed Immunoassay for Rapid Serological Diagnosis of a Specific Viral Infection in Clinical Samples


CDC researchers have developed a multiplexed diagnostic assay for sensitive detection and distinction between viral group members based on the presence/absence of infection-generated antibodies within a clinical serum sample. For example, this assay can be used for rapid discrimination of a clinical unknown as specifically a West Nile or St. Louis encephalitis viral infection. This is particularly beneficial as these two viruses are typically difficult to distinguish by standard serological assays.

This new technique uses microsphere/microbead-based flow-analysis as a platform. Because of a basis in a pre-existing technology, the technique can be easily incorporated into current state and health department diagnostic testing protocols. The method is particularly unique because the assay-generated data can be standardized and then classified via discriminant analysis to determine the presence or absence of antibodies of interest within the clinical sample tested.

Furthermore, along with allowances for single-result generation, data manipulation and classification algorithms allow for assay output comparisons to the original large data set references used in development. In this way, results from different laboratories can now be directly compared to one another, provided that the same controls are used.



Potential Commercial Applications: Competitive Advantages:
  • Clinical diagnostics for specific identification and discrimination of viral infections
  • Research tool for evaluation of vaccine candidates
  • Assay standardization and quality control
  • Public health and viral outbreak surveillance programs
 
  • Increased efficiency compared to single-antibody diagnostic approaches
  • Easily implemented and integrated into present protocols and techniques, as this technology is based on current, widely used flow-analysis platforms
  • Can be formatted as customizable kits for detection of viral group antibodies
  • Rapid and precise
  • Ideal for high-throughput analyses


Development Stage:
In vitro data available

Inventors:

Alison Basile (CDC)  ➽ more inventions...

Bradley Biggerstaff (CDC)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 7,933,721 issued 2011-04-26
U.S. Pat: 8,433,523 issued 2013-04-30
US Application No. 13/093,671
Various international patent applications pending or issued

Publications:
Basile AJ, et al. PMID 19923570
Basile AJ, et al. PMID 24086608

Licensing Contact:
Tara Kirby, Ph.D.
Email: tara.kirby@nih.gov
Phone: 240-669-5128

OTT Reference No: E-302-2013/0
Updated: Jan 17, 2014