Technology Bundle ID: TAB-3306

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

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Licensing Contact:
Primary Inventors: 
Maria Da Gloria Carvalho (CDC)
Co-Inventors: 
Lesley McGee (CDC), Maria-Lucia Tondella (CDC)
Development Stage: 
Pre-clinical (in vivo)
Institute or Center: 
CDC

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.

Applications:
  • 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
Advantages:
  • High throughput
  • High sensitivity and specificity
  • Low limit of detection
  • Rapid, accurate, and cost-effective
  • Easily adapted for use in kits

Patents

PCT Application PCT/US2008/063954
Filed on 2008-05-16
US Application 60/938,799
Filed on 2007-05-18
US Pat 8,357,488

Issued 2013-01-22

Publications

Carvalho M., et al.
PMID 17537936
Carvalho M., et al.
PMID 23825797
Diaz M., et al.
PMID 23805203
Kodani M., et al.
PMID 21471348
Pimenta F., et al.
PMID 23224094
Wu H., et al.
PMID 23339355

Updated

Jul 10, 2018

Data Source: 
tts