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CDC researchers have developed an in vitro model system designed to simulate early-stage Mycobacterium tuberculosis infection and induced granuloma formation. This modeling platform can be used for studying tuberculosis pathogenicity, identifying phenotypically-interesting clinical isolates, studying early-stage host cytokine/chemokine responses, and in vitro candidate-drug screening.

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.

HIV and AIDS remain persistent problems for the United States and countries around the world. In 2015, nearly 40,000 people were diagnosed with HIV in the US alone. Pre-exposure prophylaxis (PrEP) can help prevent HIV infections in people who are not infected with HIV but are at high risk of becoming infected with HIV. PrEP involves taking daily medications and is the most effective when medications are taken consistently. However, many people find it challenging to adhere to a daily pill schedule and cannot fully benefit from PrEP.

Cancer represents the leading cause of morbidity and mortality worldwide, with approximately 14 million new cases and 8.2 million cancer related deaths in 2012. This number is predicted to rise by approximately 70% over the next two decades according to the World Health Organization. Prognosis depends heavily on both early detection and frequent monitoring of the patient's response to treatment. Cancerous tumors shed nucleic acids into blood, which can be detected by ultra-deep sequencing of mitochondrial DNA (mtDNA).