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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.

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.

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).

CDC scientists have developed a novel enzyme immunoassay for the simultaneous detection of hepatitis C virus (HCV) core antigen and circulating HCV antibodies. Serological testing procedures for HCV circulating antibodies are well established. There is, however, a window of time between HCV infection and seroconversion that generates an opportunity for false negative results. This period varies from two months in immunocompetent subjects to six to twelve months in immunodeficient patients.

The core proteins of HIV-1 are secreted into the environment during replication in the human body. The detection of the core protein p24 (molecular mass of 24 kilodaltons) serves as an indicator of early HIV-1 infection, and assays detecting it have been available since the late 1980s. However, the development of a rapid assay for the detection of HIV-1 p24 has only recently become available.

Syphilis is a sexually transmitted disease (STD) that remains a global health threat. Syphilis rates in the United States have also been increasing. Left untreated, syphilis infection can span decades and have serious complications including blindness, dementia and paralysis. Syphilis in pregnancy causes prematurity, low birthweight, neonatal death, and infections in newborns. Improvements in syphilis detection are needed to facilitate early diagnosis of active infections and monitor treatment with antibiotics.

Syphilis, a genital ulcerative disease caused by the bacterium Treponema pallidum, is associated with significant complications if left untreated. Syphilis rates in the United States have been increasing.

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.

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.