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CDC research scientists have developed a method to identify and quantify the activity of pathogenic bacterial adenylate cyclase toxins by liquid chromatography tandem mass spectrometry (LC-MS/MS). Bacterial protein toxins are among the most potent natural poisons known, causing paralysis, immune system collapse, hemorrhaging and death in some cases.

This CDC developed invention identifies an assay for extremely fast and sensitive detection of Bacillus anthracis lethal toxin (LTx), the toxin responsible for the lethal effects of anthrax infection. This assay has already been successfully tested in animals and will allow for early detection of anthrax exposure and screening of lethal factors to monitor anthrax toxicity, for example for vaccine trial candidates.

CDC researchers have improved upon a prior, HHS patented mass spectrometry-based Endopep-MS assay that is able to rapidly detect and differentiate all seven botulinum neurotoxin (BoNT) types A to G. This current improvement comprises the addition of two optimized substrate peptides that increases the assay's sensitivity,relative to prior substrates, for botulinum neurotoxin type-E (BoNT/E) by greater than 100 fold.

Homocystinuria (HCU), a group of inherited disorders, causes symptoms ranging from failure to thrive and developmental delays in infants or young children to abnormal blood clots with onset in adults.1 Approximately 1 in 200,000 to 335,000 people have HCU globally.2

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 nucleic acid assay employs Light Upon Extension (LUX) chemistry and High Resolution Melt (HRM) analysis to detect and distinguish the different genotypes of Chlamydophila psittaci. C. psittaci is an atypical pathogen which may result in severe pneumonia upon infection of birds, mammals and humans (depending on inter-relationships between host and pathogen genotypes). Presently, C. psittaci clinical identification is achieved by a cumbersome and time-intensive mix of ompA gene sequencing, microarray analysis, RFLP and/or serological testing.

This CDC developed invention pertains to Streptococcus pneumoniae protein "pneumococcal fimbrial protein A (PfpA)," as well as the encoding pfpA gene. S. pneumoniae linked pneumococcal disease is prevalent among the very young, the elderly and also immunocompromised individuals. This invention covers the breadth of directly PfpA-related technology that might be employed for development of diagnostic tests for S. pneumoniae and/or vaccines directed against the pathogen.

Disease caused by Streptococcus pneumoniae (pneumococcus) is an important cause of morbidity and mortality in the United States and developing countries. Pneumococcal disease is prevalent among the very young, the elderly and immunocompromised individuals. This invention is an improved, immunogenic peptide construct consisting of a combination of antigenic epitopes of the PsaA (37-kDa) protein from S. pneumoniae.

CDC researchers have developed a reverse transcription/semi-nested polymerase chain reaction (RT-snPCR) assay for diagnosis of enterovirus infections within clinical specimens. Clinical laboratories currently identify enteroviruses by virus isolation and subsequent virus neutralization tests, or serological assays. In addition to being time consuming, these approaches are labor, cost and material intensive.

CDC researchers have developed a method of simultaneously detecting and distinguishing multiple antigens within a biological sample. Epidemiological and vaccine studies require species serotype identification. Current methods of serotyping are labor intensive and can easily give subjective, errant results. This technology utilizes serotype specific antibodies bound to fluorescent beads, allowing for simultaneous single tube capture and detection of multiple antigens in one rapid, high-throughput flow cytometry assay.