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Legionella pneumophila is the causative species in most cases of Legionnaires' disease (LD). CDC scientists have developed a real-time PCR assay capable of detecting all Legionella species and discriminating L. pneumophila from other Legionella species. LD is typically difficult to diagnose from a clinical standpoint as it confers no unique clinical features or symptoms. This assay provides a rapid and accurate alternative to laborious PCR assays, prone to aberrant results.

This invention relates to selective detection of human rhinovirus (HRV) in biological media. Specifically, this invention discloses a real-time TaqMan RT-PCR assay targeting the 5'-noncoding region of the HRV genome. This is a one-step, real-time nucleic acid assay that offers rapid, sensitive, and quantitative results. The assay is validated against all 100 recognized HRV prototype strains.

CDC researchers developed a simple target-specific isothermal nucleic acid amplification technique, termed Genome Exponential Amplification Reaction (GEAR). The method employs a set of four primers (two inner and two outer). The outer primer pair targets three specific nucleic acid sequences at a constant 60°C, while the inner pair of primers accelerates and improves the sensitivity of the assay. The GEAR technique is an improvement over loop-mediated isothermal amplification (LAMP) in three ways.

This invention relates to methods and compositions for rapid detection of HIV nucleic acids in a biological sample. Specifically, it involves the use of the loop-mediated isothermal amplification (LAMP) for rapid detection of HIV-1 and/or HIV-2. The use of rapid HIV tests is highly attractive for screening of patient samples, especially in developing countries where resources are limited, because they are quick, easy to perform, and do not require any special equipment.

Bacillus anthracis is a gram-positive, spore-forming bacteria that causes anthrax infection in humans. CDC inventors have identified epitope sequences of B. anthracis protective antigen (PA) that may be useful for development of peptide-based anthrax vaccines. This invention also relates to methods for determining whether post-vaccination protection is achieved. Specifically, this invention relates to a screening method for determining protection against B.

This invention relates to a genetically modified hemorrhagic fever virus that can be used as an effective live vaccine agent. Hemorrhagic fever evades the human immune response using the viral ovarian tumor domain (vOTU) protease, which inhibits critical host-immunity functions. The present genetically modified virus has a vOTU protease with decreased ability to remove ubiquitin (Ub) and ISG15 tags from proteins in cells it infects. Thus, the virulence is reduced, creating an immunogenic and non-pathogenic virus for use as a live vaccine against Crimean-Congo hemorrhagic fever (CCHF) virus.

This technology relates to a method of generating artificial compositions that can be used as positive controls in a genetic testing assay, such as a diagnostic assay for a particular genetic disease. Such controls can be used to confirm the presence or absence of a particular genetic mutation. The lack of easily accessible, validated mutant controls has proven to be a major obstacle to the advancement of clinical molecular genetic testing, validation, quality control (QC), quality assurance (QA), and required proficiency testing.

Our technology describes unique genetic signatures in patients with digestive diseases and liver disorders. Using comprehensive analysis of 735 microRNAs and 19,000 mRNAs, we have identified a unique set of microRNAs and/or mRNAs which predict disease phenotypes in patients with digestive and liver disorders. The identification of such point-of- care genetic signatures is significant for both personalized biomarkers and novel targeted biotherapeutics. These microRNAs and mRNAs function either together or separately thus modulating protein expressions in one or more signaling pathways.

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 more efficient method of assessing rabies vaccine potency using an antigen-capture electrochemiluminescent (ECL) assay. This assay utilizes SULFO-NHS-Ester labeled murine monoclonal antibodies to quantify glycoprotein concentration, which is an indicator of vaccine potency. Currently, the potency of rabies vaccines is determined by the effective-dose (ED50) mouse study evaluation method, which is more than 50 years old.