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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.

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).

This CDC-developed technology entails a nucleic acid-based HIV-2 in vitro diagnostic assay that is well-suited for use in mobile testing units/vehicles or resource-limited settings, for example, many areas of West Africa. Because HIV-2 requires unique treatment regimens, accurate, early diagnosis is crucial for effective care and directing treatment. Recently, new HIV testing recommendations have been proposed for laboratory settings, which include the use of a HIV-1/HIV-2 discriminatory assay.

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.

A retrovirus can be any of a group of RNA viruses (i.e., HIV) that insert a DNA copy of their genome into the host cell in order to replicate. Retroviruses can cause persistent and often lifelong infections.

Syphilis is a highly contagious sexually transmitted disease caused by the bacterium, Treponema pallidum (T. pallidum). If left untreated, syphilis can cause serious complications including blindness, paralysis and dementia.

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.