This CDC-developed technology entails novel compositions and methods related to the diagnosis of Lyme disease. Lyme disease, caused by the Borrelia burgdorferi bacterium, is the most common tick-borne infectious disease in the US and Europe. Diagnosis of Lyme disease is particularly challenging as symptoms often appear long after exposure. At present, the only FDA-approved diagnostic for Lyme disease involves patient blood tests for particular antibodies; these include an ELISA to measure patient antibody levels and a Western blot assay to detect antibodies specific to B.

Sjögren’s is a chronic autoimmune disease characterized by dry mouth and eyes, fatigue, and musculoskeletal pain resulting from the attack of the moisture-producing glands by the body’s own white blood cells. The subject invention is based on the discovery of an association between infection by a novel clade 1 variant of hepatitis delta virus (HDV) and primary Sjögren’s syndrome.

In order to develop a simple detection assay for field use, CDC researchers cloned and sequenced the Taenia solium T24 diagnostic protein. The T24 sequences can be used to detect and diagnose T. solium infection or can be formulated into a pharmaceutical composition. T. solium is a species of tapeworm. Intestinal infection with T. solium is referred to as taeniasis. Many taeniasis infections are asymptomatic but may be characterized by insomnia, anorexia, abdominal pain and weight loss. Cysticercosis infection, which can be fatal, may develop if T.

This invention relates to synthetic immunoreactive peptides, which are portions of the M proteins of the most prevalent Group A Streptococcus (GAS) serotypes in the United States. These peptides may be useful in development of a flexible, multivalent GAS vaccine. They can be recognized by M type-specific antibodies and are capable of eliciting functional opsonic antibodies. Additionally, the peptides or isolated antibodies raised in response to the peptides may be useful for GAS diagnostics.

B. burgdorferi-infected ticks can cause Lyme disease in mammalian hosts. This technology relates to the use of B. burgdorferi outer surface proteins (BBA64 and BBA66) as Lyme disease vaccine candidates. In vivo animal studies demonstrate these outer surface proteins inhibit tick-to-host B. burgdorferi transmission. Presently, there is no vaccine approved for Lyme disease.

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.

The vast majority of people infected with Hepatitis C Virus (HCV) will have chronic infection. Over decades, this can lead to liver disease and liver cancer. In fact, HCV infection is the leading cause of liver transplants in the U.S. Several new drugs have recently come into the market that will likely change the HCV treatment paradigm. However, the effectiveness of these new drugs can vary depending on the HCV genotype. Thus, there is still the need for additional new therapeutics against HCV.

Chikungunya virus (CHIKV) is mosquito-borne alphavirus endemic in Africa, India, and Southeast Asia. In 2013 CHIKV infection has also emerged in the Caribbean and a pandemic of CHIKV has re-emerged in the Philippines following Typhoon Haiyan. Currently, there is no vaccine available for the prevention of CHIKV infection and no specific therapy exists to treat the illness.

CDC researchers have developed improved Loop-Mediated Isothermal Amplification (LAMP) assays for the nucleic acid-based diagnosis of malaria in field settings. The approach employs Plasmodium genus-specific LAMP primers and a portable tube scanner to run the LAMP reaction and measure fluorescence signal (e.g., SYBR green) as a measure of DNA amplification in real time. Using this platform, the researchers were able to detect several different species of the human malaria parasites.

CDC scientists have developed a device for simultaneous rapid diagnosis of HIV infection and for identification of recent HIV-1 infection. The device utilizes immunochromatographic or flow-through principles to detect HIV antibodies within clinical samples. This device may be used for diagnosis of HIV infection, as well as to distinguish between recent infection (6 months) and long-term infection (>1 year).