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CDC researchers have developed a real-time PCR assay for the detection of Neisseria meningitidis sodC within clinical specimens. The ability to detect all strains of N. meningitidis, regardless of individual serogroup, is the central innovation of this technology. Further, the assay is sensitive enough to detect even the very limited sample sizes of N. meningitidis that would typically be found in clinical specimens. This technology avoids potentially catastrophic false-negative results associated with current N.

CDC researchers developed a real-time PCR assay targeting insertion sequence (IS481) and pertussis toxin subunit 1 (ptxS1) of Bordetella pertussis. This real-time nucleic acid assay offers rapid, sensitive, and quantitative results. The employed primers have been validated through extensive diagnostic testing of 41 Bordetella and 64 non-Bordetella clinical isolates. This technology can be used to diagnose and distinguish B. pertussis, B. parapertussis and B.

CDC scientists have developed a real-time PCR assay for diagnosing pneumococcal disease using amplification of the bacterial gene encoding pneumococcal surface adhesin A (PsaA). Pneumococcal isolation and identification is often complicated by 1) antimicrobial suppression of growth in culture and 2) contamination by normal flora alpha-streptococci. Further, pneumococcal detection by culture and serological methods can be time-consuming, relatively expensive, laborious and, ultimately, indeterminate.

This invention describes materials and methods of detecting novel influenza virus in a sample. As highlighted by the recent H1N1 pandemic strain, influenza viruses are constantly evolving and novel reassortments can quickly spread around the world.

The CDC developed a real-time reverse transcription polymerase chain reaction (RT-PCR) Taqman assay and an RT-semi nested PCR (RT-snPCR) assay for the detection of parechoviruses. Similar to enteroviruses, parechoviruses are responsible for gastrointestinal, respiratory and central nervous system infections. All tests target conserved regions in the 5'-nontranslated region (5-'NTR) of the parechovirus genome and share forward and reverse primers. The Taqman probe and RTsnPCR nested primer target the same conserved site but vary in length.

In order to address a global need for rapid, cost-effective, sensitive, and specific assays for many pathogens, CDC scientists have developed a broad-use, multiplexed RT-PCR assay. This comprehensive assay covers numerous pathogens that are common causes of infection in neonates and also important to food-safety.

CDC researchers have developed a single-tube, real-time PCR assay for the simultaneous detection of three bacterial respiratory pathogens (Mycoplasma pneumoniae, Chlamydiophila pneumoniae and Legionella spp.). The assay has an internal control testing for presence of human DNA. This four-plex real-time PCR assay could potentially become a routine screening test for patients with respiratory illness. Ninety four clinical specimens (in a 96-well format) can be tested at once. This assay is non-invasive, rapid and cost-effective.

Haemophilus influenzae is responsible for life-threatening respiratory infections including meningitis. This assay allows for the qualitative detection of the bacterial meningitis pathogen H. influenzae serotype A (Hia) and serotype B (Hib) in fluid samples, without detecting any of the other serotypes of H. influenzae. This invention is capable of detecting even the very small numbers of Hia or Hib within clinical specimens.

This invention relates to methods of rapidly detecting influenza, including differentiating between type and subtype. Unlike culture and serological tests requiring 5 to 14 days for completion, CDC researchers developed a rapid, accurate assay, which is easily adapted to kit form. This assay also requires less labor input than immunoassays. These methods can be used to quickly identify a broad variety of influenza types and subtypes, including viruses that may be involved in pandemics (such as H5N1, for example).

Progressive multifocal leukoencephalopathy (PML) is a rare, fatal demyelinating disease of the brain caused by the polyomavirus JC (JCV) under immunosuppressive conditions. It is pathologically characterized by progressive damage of white matter of the brain by destroying oligodendrocytes at multiple locations. Clinically, PML symptoms include weakness or paralysis, vision loss, impaired speech, and cognitive deterioration. The prognosis of PML is generally poor. No effective therapy for PML has been established.