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This invention relates to methods and compositions for rapid detection of HIV nucleic acids in a biological sample. Specifically, it involves the use of the loop-mediated isothermal amplification (LAMP) for rapid detection of HIV-1 and/or HIV-2. The use of rapid HIV tests is highly attractive for screening of patient samples, especially in developing countries where resources are limited, because they are quick, easy to perform, and do not require any special equipment.

CDC scientists have developed a one-step TaqMan quantitative/real-time reverse transcription-polymerase chain reaction (qRT-PCR) assay for detecting hepatitis D virus (HDV) RNA. Additionally, a quantifiable synthetic RNA control to determine viral load has been created.

CDC scientists developed immunogenic multi-clade, multivalent (HIV1MCMV) recombinant constructs for use as HIV-1 vaccines. These polypeptides include immunogenic CTL, T- and/or B-cell determinants that are capable of eliciting broad and effective immune responses against diverse subtypes of HIV-1. It is believed that these HIV-1 constructs provide universal vaccines, capable of effective use in any part of the world affected by the HIV-1 epidemic.

CDC researchers have isolated and characterized the novel primate T-lymphotropic viruses denoted human T-lymphotropic viruses 3 and 4 (HTLV-3 and HTLV4), that are believed to have resulted from cross-species transmission at some point in the past. It has been previously established that HTLV-1 causes adult T cell leukemia and other inflammatory diseases; HTLV-2 is considered less pathogenic than HTLV-1 and has been associated with a neurologic disease similar to HTLV-1-associated myelopathy.

One of the problems with the development of current therapies for HIV infection is that the virus rapidly develops resistance to drugs such as reverse transcriptase (RT) inhibitors.

This CDC-developed technology relates to novel vaccines or boosters directed against pulmonary tuberculosis. There is currently only a single vaccine against tuberculosis, the (Bacillus Calmette-Guérin) BCG vaccine. Reports suggest widely variable effectiveness for the BCG vaccine and that BCG administration has very limited success against prevention of the primary pulmonary form of the disease.

This invention provides materials, methods, and assays for detecting HIV-1 groups M and O and optionally HIV-1 group N and simian immunodeficiency virus-cpz (SIV-cpz). Specific nucleic acid primers for hybridization, amplification, and detection of HIV-1 are also provided for. The nucleic acid amplification assays can detect small concentrations of HIV-1 and are also useful for quantitative examinations of viral load concentrations within biological samples.

This novel assay features real-time PCR reagents and methods for detecting drug-resistance related mutations in HIV, for newly diagnosed patients and those individuals currently receiving antiretroviral therapies. As the use of antiretroviral compounds to treat HIV infection proliferates, viruses adapt and evolve mutations limiting the efficacy of these drugs and disrupting the success of treatment.

This CDC developed Limiting-Antigen avidity Enzyme Immunoassay (LAg-avidity-EIA) provides an easy way to measure increasing binding strength (avidity) of HIV antibodies as part of maturation HIV antibodies after seroconversion, providing a method to distinguish early-stage from long-term HIV-1 infection. Surveillance of HIV-1 provides information on prevalence rates of the disease, but determination of new infection rates (HIV-1 incidence) is difficult to deduce. Longitudinal follow up is expensive and can be biased.

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.