Technology ID
              TAB-3306
          Real-time PCR Detection of <em>Streptococcus pneumoniae</em> with High Sensitivity and Specificity
E-Numbers
          E-288-2013-0
              Lead Inventor
          Carvalho, Maria Da Gloria
              Lead IC
          CDC
              Co-Inventors
          McGee, Lesley
          Tondella, Maria-Lucia
              ICs
          CDC
              Applications
          Therapeutics
          Research Materials
          Occupational Safety and Health
          Diagnostics
          Consumer Products
              Therapeutic Areas
          Infectious Disease
              Development Stages
          Pre-Clinical (in vitro)
              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.
      
  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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