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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 synthetic immunoreactive peptides, which are portions of the M proteins of the most prevalent Group A Streptococcus (GAS) serotypes in the United States. These peptides may be useful in development of a flexible, multivalent GAS vaccine. They can be recognized by M type-specific antibodies and are capable of eliciting functional opsonic antibodies. Additionally, the peptides or isolated antibodies raised in response to the peptides may be useful for GAS diagnostics.

This Intranasal Dry Powder Inhaler (DPI), developed with Creare, Inc., allows low-cost delivery of powder vaccines. Nasal delivery has numerous advantages compared to traditional injected vaccines, including: 1) safe, needle-less administration by minimally-trained staff or patient; 2) better protection due to mucosal and cross-protection; and 3) decreased biohazard waste.

Intranasal delivery is a simple, inexpensive and needle-free route for administration of vaccines and therapeutics. This intranasal delivery technology, developed with Creare LLC., includes low-cost, disposable drug cartridges (DDCs) that mate with a durable hand-held device. The rechargeable-battery-powered device transmits ultrasonic energy to the DDC to aerosolize the drug and is capable of performing for eight hours at 120 vaccinations per hour. Potential applications for this platform technology include intranasal vaccination (e.g.

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).