Improved Botulism, Botulinum Neurotoxin Type-E Diagnostics

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.

Multiplexing Homocysteine in Primary Newborn Screening Assays Using Maleimides as Select Derivatization Agents

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 Nebulizer with Disposable Drug Cartridge for Improved Delivery of Vaccines and Therapeutics

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.

Real-time PCR and High Resolution Melt Analysis for Genotyping of Chlamydophila psittaci

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.

Antigen, Encoding Gene, Related Monoclonal Antibody and Hybridoma Clones for Streptococcus pneumoniae Serological Diagnostics

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.

Multi-Antigenic Peptide(s) Vaccine and Immunogen for Conferring Streptococcus pneumoniae Immunity

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.

Enterovirus Molecular Diagnostic Test Kit

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.

Methods for the Simultaneous Detection of Multiple Analytes

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.

Peptide Sequences for Chlamydophila pneumoniae Vaccine and Serological Diagnosis

CDC researchers have isolated select Chlamydophila pneumoniae peptide epitopes for development of vaccines and diagnostic assays. Currently, C. pneumoniae infection of humans has been linked to a wide variety of acute and chronic diseases, such as asthma, endocarditis, atherosclerotic vascular disease, chronic obstructive pulmonary disease, sarcoidosis, reactive arthritis and multiple sclerosis. There is presently no available peptide vaccine for the pathogen and reliable and accurate diagnostic methods are limited.

Human Influenza Virus Real-time RT-PCR: Detection and Discrimination of Influenza A (H3N2) Variant from Seasonal Influenza A (H3N2) Viruses, Including H3v and Seasonal H3 Assays

This invention relates to methods of rapidly detecting influenza, including differentiating between type and subtype. CDC researchers have developed a rapid, accurate, real-time RT-PCR assay that has several advantages over culture and serological tests, which require 5 to 14 days for completion; this assay can also be easily implemented in kit form. To date, hundreds of human cases of infection with the H3N2 variant virus have been confirmed.