Immunoassay for the Simultaneous Detection of Functional Antibodies against Multiple Serotypes of Streptococcus pneumoniae and Other Bacteria Types


Streptococcus pneumoniae, or pneumococcus, is a type of bacteria that causes pneumococcal disease. Pneumococcal infections can range from ear and sinus infections to pneumonia and bloodstream infections. Children younger than 2 years old and adults 65 years or older are among those most at risk for disease.

CDC inventors have developed a simple, rapid flow, cytometric opsonophagocytic (mOPA) assay for the detection of functional antibodies against Streptococcus pneumoniae (S. pneumoniae)<. This in vitro assay measures functional antibody activity (of the phagocytes ingesting and eliminating pathogens) in samples from a subject vaccinated with a multivalent vaccine or after exposure to a bacterial pathogen. This assay can use a metabolic dye indicator that provides a colorimetric indicator of bacterial growth. As a result, neither growing bacteria into colonies, nor colony counting is needed, hence minimizing handling of viable bacteria. Alternately, the assay can also use fluorescently labelled beads conjugated with bacterial antigens, allowing rapid readout by flow cytometry. CDC’s technology demonstrates high reproducibility, detects up to 90 different S. pneumoniae serotypes, and can be adapted easily for automation.

Additionally, CDC’s technology will save time and resources versus the standard opsonophagocytic killing assay (OPK), a singleplex resource-intensive cell-based assay. At present time, OPK stands as the only in vitro correlate accepted by regulatory agencies for pneumococcal vaccine licensure. CDC’s mOPA addresses this major bottleneck in the pneumococcal vaccine evaluation by demonstrating efficacy of multivalent (i.e., 13-valent) vaccines. With more countries including pneumococcal vaccines in their immunization schedules, there is a strong need for this technique.

Potential Commercial Applications: Competitive Advantages:
  • Medical diagnostic for detection of multiple (up to 90) Streptococcus pneumoniae serotypes
  • Evaluate immune responses to vaccines or pathogens
  • Large-scale immunogenicity studies
  • Evaluation of existing or new pneumococcal vaccines for vaccine efficacy
  • mOPA can be used with other types of bacteria, such as Neisseria meningitidis and Hemophilus influenzae
  • Monitoring and public health surveillance
 
  • Multiple (up to 90 different) serotypes can be evaluated in a single multivalent assay versus the current singleplex standard assay
  • Reduced assay time and reduced amount of serum
  • Minimizes handling of viable bacteria
  • High reproducibility
  • Can be automated


Related Invention(s):
E-329-2013-0


Inventors:

Sandra Steiner (CDC)  ➽ more inventions...

Patricia Holder (CDC)  ➽ more inventions...

George Carlone (CDC)  ➽ more inventions...

GowriSankar Rajam (CDC)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 7,642,068 issued 2010-01-05
PCT Application No. PCT/US2006/015499
US Application No. 11/910,517
US Application No. 12/620,772
National Patents Issued in Australia, Canada, and Europe

Publications:
Martinez JE, et al. PMID: 10391867
Romero-Steiner S., et al. PMID: 14607861
Bieging KT, et al. PMID: 16210490
Martinez J, et al. PMID: 11874898
Martinez JE, et al. PMID: 16603613
Romero-Steiner S., et al. PMID: 9220157
Romero-Steiner S., et al. PMID: 16467321

Collaboration Opportunity:

The CDC Technology Transfer Office (TTO) is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize: Immunoassay for the Simultaneous Detection of Functional Antibodies against Multiple Serotypes of Streptococcus pneumoniae and Other Bacteria Types. For collaboration opportunities, please contact CDC TTO at tto@cdc.govor 1-404-639-1330


Licensing Contact:
Karen Surabian, J.D., M.B.A.
Email: karen.surabian@nih.gov
Phone: 301-594-9719

OTT Reference No: E-227-2013-0
Updated: Jun 26, 2018