Real-time PCR Detection of Streptococcus pneumoniae with High Sensitivity and Specificity


Streptococcus pneumoniae is the leading cause of community-acquired pneumonia and is also a frequent cause of bloodstream, brain and spinal cord, ear, and sinus infections. According to 2015 CDC data, an estimated 900,000 Americans get pneumococcal pneumonia each year and approximately 5-7% die from it annually. Accurate diagnosis and early treatment are important for improving patient outcomes.

Pneumonia is typically diagnosed by clinical examination, chest X-rays, and culture of patient blood and secretions. X-rays cannot identify the pathogen; blood cultures take several days to grow with limited reliability; and sputum and throat culture specimens collected may not contain isolates of the organism. CDC researchers developed a Taqman-based assay that uses real-time PCR to detect three specific gene regions of S. pneumoniaewith a very low limit of detection of 10 copies, and has shown high sensitivity and specificity against a panel of 67 CDC S. pneumoniae isolates. Targeting multiple genes, this technology would perform well in a multiplex diagnostic testing application.



Potential Commercial Applications: Competitive Advantages:
  • Diagnosis of respiratory disease from sterile clinical samples (e.g., serum, blood, CSF, pleural fluid)
  • Surveillance of pneumococcal carriage from non-sterile samples (e.g., nasopharyngeal swab)
  • Validation studies and proficiency testing
 
  • High throughput
  • High sensitivity and specificity
  • Low limit of detection
  • Rapid, accurate, and cost-effective
  • Easily adapted for use in kits


Inventors:

Lesley McGee (CDC)  ➽ more inventions...

Maria-Lucia Tondella (CDC)  ➽ more inventions...

Maria Da Gloria Carvalho (CDC)  ➽ more inventions...


Intellectual Property:
U.S. Pat: 8,357,488 issued 2013-01-22
PCT Application No. PCT/US2008/063954
US Application No. 12/600,568

Publications:

Carvalho M., et al.

PMID 17537936

Carvalho M., et al.

PMID 23825797

Diaz M., et al.

PMID 23805203

Pimenta F., et al.

PMID 23224094

Wu H., et al.

PMID 23339355

Kodani M., et al.

PMID 21471348

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: Real-time PCR Detection of Streptococcus pneumonia with High Sensitivity and Specificity. For collaboration opportunities, please contact CDC TTO at tto@cdc.gov or 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-288-2013-0
Updated: Aug 1, 2018