Monoclonal Antibody to Detect the Antiretroviral Drug Emtricitabine – for HIV Drug Adherence Monitoring

The U.S. Food and Drug Administration and World Health Organization (WHO) approved the antiretroviral drug emtricitabine (FTC)/ tenofovir disoproxil fumurate (TDF) combination for HIV pre-exposure prophylaxis (PrEP) in high risk populations. Efficacy of PrEP depends strongly on adherence to taking the FTC/TDF pill daily. In the US, the Centers for Disease Control and Prevention (CDC) estimates that 1.2 million Americans will benefit from PrEP. FTC is also a key component of antiretroviral therapy (ART) regimens of HIV-infected persons and significantly associated with adherence.

Simian T-Cell Lymphotropic Virus Strain Type 3 (STLV-3) Subtype D Variant, a Highly Divergent STLV-3, for Development of Diagnostics, Therapeutics, Vaccines and Research Tools

Simian T-cell lymphotropic viruses (STLV) are nonhuman primate retroviruses closely related to the human T-lymphotropic virus (HTLV). Types I, II, and III of HTLV have been found in humans and are believed to have originated from cross-species transmission of STLV from infected nonhuman primates. The HTLV viruses are known to cause leukemia, lymphoma, and neurological disorders.

Monoclonal Antibodies for the Detection of Antiretroviral Integrase Inhibitors

Pre-exposure prophylaxis (PrEP) is a critical component in the fight against HIV but is only effective if persons prescribed PrEP are adhering to the regimens to maintain appropriate drug levels. As PrEP regimens have moved from daily pills to longer lasting injections, the ability to quickly measure and monitor the circulating drug levels of PrEP drugs has increased importance.

Detection of Hepatitis C Virus for point of care kit

Hepatitis C virus (HCV) is a major global health problem with an estimated 58 million infections in 2019.  However, most HCV infections go undiagnosed due to the lack of clinical symptoms or for lack of access to simple and affordable diagnostic testing. It is estimated that only 21% and 61% of people with a chronic HCV infection have been diagnosed, worldwide and in the United States, respectively.

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.

Sensitive Method for Detection and Quantification of Anthrax, Bordetella pertussis, Clostridium difficile, Clostridium botulinum and Other Pathogen-Derived Toxins in Human and Animal Plasma

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.

Exposure and Activity Detection Assays for Anthrax Lethal Factor and Lethal Toxin

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.

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
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