Technology Bundle ID: TAB-3306

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

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

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.

  • 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


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


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PMID 17537936
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PMID 23805203
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PMID 21471348
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PMID 23224094
Wu H., et al.
PMID 23339355


Jul 10, 2018

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