Immunogenic Hepatitis E Virus Polypeptides for Vaccine and Diagnostics Development

This technology comprises specific hepatitis E virus (HEV) antigenic polypeptides. HEV causes epidemic and sporadic cases of hepatitis outbreaks with a mortality rate as high as 20% for pregnant women. In order to address this problem, CDC scientists carried out thorough HEV antigen screenings and subsequently developed recombinant proteins that efficiently model major HEV neutralization epitope(s). These recombinant proteins may be considered as candidates for the development of an HEV subunit vaccine, as well as for the development of highly sensitive and specific diagnostic tests.

Real-time PCR Assays for Human Bocavirus Detection and Diagnosis

CDC researchers have developed a real-time PCR assay for the detection and viral-load quantitative estimations of human bocavirus (HBoV) from clinical specimens. At present, there have been few reports on the epidemiology, geographic distribution or clinical features of HBoV infection. Additionally, symptoms affiliated with bocavirus infections overlap with numerous other respiratory illnesses. This CDC assay provides sensitive, specific, and quantitative detection of HBoV in patients with respiratory illness by a method of real-time PCR targeting the HBoV NS1 and NP-1 genes.

Detection of Retroviruses and HIV-1 Groups -M and -O Discrimination within Clinical Serum Samples

CDC researchers have developed methods for detecting retroviruses within a patient blood sample and discriminating HIV-1 samples within serum specimens. HIV-1 can be genetically classified into two major groups, group M (major) and Group O (outlier) with group O comprising all divergent viruses that do not cluster with group M. The identification of group O infections raised public health concerns about the safety of the blood supply because HIV-1 screening by group M-based serologic tests does not consistently detect group O infection.

Virus Microneutralization Assay Data Analysis for Vaccine Development, Enhancement and Efficacy Improvement

This CDC generated invention entails improved methods of analyzing microneutralization assays, especially for the purposes of determining specific antibody concentrations and optimizing vaccine formulation. More specifically, the invention is a set of SAS based programs using 4-parameter logistic curve fitting algorithms to interpolate between individual data points, allowing for enhanced accuracy and precision when establishing neutralization titers.

Stable, Early-stage Biomarker for Diagnosis of Bacillus anthracis Infection and Anthrax Vaccine Development

This invention comprises monoclonal antibodies, proteins, and related nucleic acid coding sequences that identify all or part of the antigenic anthrose oligosaccharide of Bacillus anthracis, the causative agent of anthrax toxicity in humans. It is imperative to identify virulent B. anthracis with speed and specificity, however there presently is substantial difficulty in early-stage recognition and diagnosis of anthrax inhalation.

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.

Human Influenza Virus Real-time RT-PCR Detection and Characterization Panel

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).

Improved Protein Quantification Process and Vaccine Quality Control Production

This CDC invention is a method for identifying and quantifying a group of proteins in a complex mixture by a liquid chromatography-tandem mass spectrometry assay. The technology was developed for influenza although it can be used for a wide variety of protein quantification applications. As specifically developed, conserved peptides from the proteins of influenza (hemagglutinin, neuramidase, matrix 1 and 2, and nucleoprotein) have been synthesized and labeled to be used as internal standards for the quantification of those proteins in a complex (biological or manufactured) matrix.

Controlled Expression and Assembly of Human Group-C Rotavirus-like Particles for Creation of Rotavirus Diagnostic Assays and Improved Vaccine Formulations

CDC researchers have developed methods of producing unlimited quantities of Group-C (GpC) rotavirus antigens. GpC rotaviruses are a major, worldwide cause of acute gastroenteritis in children and adults that is distinct from Group-A rotavirus. However, GpC rotaviruses cannot be grown in culture, resulting in a lack of tools for detection and treatment of GpC rotavirus disease.

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.