Technology Bundle ID
TAB-3306

Real-time PCR Detection of <em>Streptococcus pneumoniae</em> with High Sensitivity and Specificity

Linked ID
E-288-2013-0
Lead Inventors
Maria Da Gloria Carvalho (CDC)
Co-Inventors
Lesley McGee (CDC)
Maria-Lucia Tondella (CDC)
Development Stages
Pre-clinical (in vivo)
ICs
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.
Commercial 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
Competitive Advantages
  • High throughput
  • High sensitivity and specificity
  • Low limit of detection
  • Rapid, accurate, and cost-effective
  • Easily adapted for use in kits

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