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Counterfeit drugs (also known as “fake or falsified medicines”) have become a major world-wide public health concern. Falsified medicines may contain toxic substances, the wrong active ingredients, suboptimal amounts of active ingredients, or no active ingredients at all. CDC researchers developed a portable (handheld), battery-operated, and relatively inexpensive device that non-trained personnel can use quickly to evaluate a particular branded tablet for authenticity.

A major challenge to sequencing eukaryotic parasites present in clinical samples is the abundance of ‘contaminating’ human DNA in samples. CDC has developed a method to reduce host DNA from biological samples prior to sequencing of the 18s gene, a universal gene which allows scientists to detect any parasitic organism by one DNA test.

CDC researchers have developed a patented set of RT-PCR and sequencing primers based on HIV-1 group M sequences. Evaluation of the primers using samples collected around the world demonstrated broad detection capacity for multiple HIV-1 group subtypes and predominant circulating recombinant forms. Commercially available HIV-1 drug resistance (HIVDR) genotyping assays are expensive and have limited ability to detect non-B subtypes. This optimized assay is broadly sensitive in genotyping HIV-1 group M viral strains and more sensitive than other assays in detecting mixed viral populations.

Micro-Screen is a CDC developed software program designed to capture images and archive and display a compiled image(s) from a portion of a microscope slide in real time. This program allows for the re-creation of larger images that are constructed from individual microscopic fields captured in up to five focal planes and two magnifications. This program may be especially useful for the creation of data archives for diagnostic and teaching purposes and for tracking histological changes during disease progression.

Within recent years, point-of-care (POC) testing has allowed for many individuals to be screened for and provided with HIV test results. It is critical to be able to accurately detect acute HIV infections as this is a stage where the risk of transmission is great. Additionally, early HIV detection could lead to less high-risk behavior, thereby reducing transmission. Currently, there are no rapid, cost-effective diagnostic tests sensitive enough to detect acute HIV-1 infections for the POC setting.

CDC scientists have developed a rapid, sensitive, and specific real-time PCR assay that is capable of detecting the presence of Mycobacterium tuberculosis and determining its resistance profile to antibiotics, such as rifampicin and isoniazid. Currently, there are few assays available that are capable of both detecting M. tuberculosis and determining the bacteria's drug resistance. This assay incorporates multiple fluorescent chemistries, providing a simple and cost-effective method of determining the bacteria's drug resistance.

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.