Multiplexed Immunoassay for Rapid Serological Diagnosis of a Specific Viral Infection in Clinical Samples

CDC researchers have developed a multiplexed diagnostic assay for sensitive detection and distinction between viral group members based on the presence/absence of infection-generated antibodies within a clinical serum sample. For example, this assay can be used for rapid discrimination of a clinical unknown as specifically a West Nile or St. Louis encephalitis viral infection. This is particularly beneficial as these two viruses are typically difficult to distinguish by standard serological assays.

This new technique uses microsphere/microbead-based flow-analysis as a platform.

Novel Epitopes of Bacillus anthracis Lethal Factor for Development of Diagnostics and Therapeutics

CDC researchers have characterized epitopes of Bacillus anthracis Lethal Factor (LF), a critical component of the B. anthracis lethal toxin. These epitopes may allow for development of therapeutics for the treatment or prevention of B. anthracis infection. They may also allow screening for B. anthracis LF in a sample and development of a peptide anthrax vaccine.

Diagnostics, Vaccines, and Delivery-Vehicles Related to Novel Phlebovirus

This CDC invention relates to primers and probes that specifically hybridize with Heartland virus (HRTLDV), a unique member of the genus Phlebovirus. It further relates to polyclonal antibodies specific for HRTLDV proteins. Serological detection assays using HRTLDV nucleic acid molecules, proteins, probes, primers, and antibodies are provided. Importantly, the HRTLDV genome can be engineered using reverse genetics to be attenuated, allowing development of a vaccine for other viruses within the Phlebovirus genus or Bunyaviridae family.

Human lgA Monoclonal Antibody that Targets a Conserved Site on the Plasmodium Falciparum Circumsporozoite Protein

Scientists at NIAID have isolated MAD2-6, an IgA antibody active against Plasmodium falciparum sporozoites, the infectious agent of malaria. In 2019, the majority of the 229 million cases resulted from P. falciparum infections. Because P. falciparum has a complex lifecycle during human infection, most advanced malaria vaccine candidates and current chemoprophylaxis drugs can confer only partial, short-term protection in malaria-endemic areas. Thus, the MAD2-6 antibody could be used alone or in combination with current technology.

A Broadly Protective Human Antibody for GI Genogroup Noroviruses

Norovirus is a leading cause of vomiting, diarrhea, and foodborne illness worldwide, with 700 million cases and 200,000 deaths occurring each year. Despite decades of work in the field, there are no preventive or therapeutic strategies specifically approved for even the most prevalent forms of human norovirus (i.e., GI, GII genogroups), which are highly contagious and carry an increased risk of severe complications in children, older adults, and those with immunocompromising conditions. 

Recombinant Polypeptides for Clinical Detection of Taenia solium and Diagnosis of Cysticercosis

CDC scientists have developed synthetic/recombinant polypeptides that can be used for the creation of inexpensive, high-quality cysticercosis diagnostic assays. Taenia solium is a species of pathogenic tapeworm. Intestinal infection with this parasite is referred to as taeniasis and it is acquired by ingestion of T. solium cysticerci found in raw and undercooked pork, or food contaminated with human or porcine excrement. Many infections are asymptomatic, but infection may be characterized by insomnia, anorexia, abdominal pain and weight loss.

Novel One-Well Limiting-Antigen Avidity Enzyme Immunoassay to Detect Recent HIV-1 Infection Using a Multi-subtype Recombinant Protein

This CDC developed Limiting-Antigen avidity Enzyme Immunoassay (LAg-avidity-EIA) provides an easy way to measure increasing binding strength (avidity) of HIV antibodies as part of maturation HIV antibodies after seroconversion, providing a method to distinguish early-stage from long-term HIV-1 infection. Surveillance of HIV-1 provides information on prevalence rates of the disease, but determination of new infection rates (HIV-1 incidence) is difficult to deduce. Longitudinal follow up is expensive and can be biased.

Diagnostic Antigens for the Identification of Latent Tuberculosis Infection

CDC researchers have developed technology for sero-diagnosis of typically symptomless latent stage tuberculosis disease, posing a threat to individuals under immunosuppressive or anti-inflammatory therapies. Specifically, this diagnostic approach exploits M. tuberculosis secreted latency specific antigens, such as alpha-crystallin, in the blood or urine of patients.

Multiple Antigenic Peptide Assays for Detection of HIV and SIV Type Retroviruses

CDC scientists have developed multiple antigenic peptide immunoassays for the detection of human immunodeficiency virus (HIV) and/or simian immunodeficiency virus (SIV). HIV can be subdivided into two major types, HIV-1 and HIV-2, both of which are believed to have originated as result of zoonotic transmission. Humans are increasingly exposed to many different SIVs by wild primates. For example, human exposure to SIVs frequently occurs as a consequence of the bush meat hunting and butchering trade in Africa.

Multivalent, Multiple-Antigenic-Peptides for Serological Detection of HIV-1 Groups -M, -N, -O, and HIV-2

This CDC-developed invention pertains to multivalent antigenic peptides (MAPs) that can be used in a variety of HIV/AIDS diagnostics. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is subdivided into groups M, N, and O, while HIV-2 is subdivided into subtypes A and B. Within HIV -1 group M, several different subtypes and numerous forms of recombinant viruses exist. To detect all types, groups, and subtypes of HIV by serological methods, a mixture of antigens derived from different viral strains representing different HIV types and subtypes is needed.
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