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The Zika virus (ZIKV) can be passed from a pregnant woman to her fetus. Resulting infection by this virus can cause early miscarriage and a pattern of severe birth defects in fetuses and infants. Therefore, a rapid diagnostic assay that can be performed throughout pregnancy in a clinical setting is vital for prenatal care of women living in areas where this virus may be transmitted.

Antibiotic resistance is one of the world's most pressing health concerns. ß-lactamases, such as carbapenemases, are enzymes produced by bacteria that provide resistance to multiple ß-lactam antibiotics (e.g., penicillins, cephamycins, and carbapenems) by breaking down the antibiotic molecules and deactivating their antibacterial properties. Carbapenems are broad-spectrum antibiotics often prescribed to treat serious infections in hospitalized patients, and infections with carbapenem-resistant Enterobacteriaceae (CRE) have become a challenge in healthcare settings.

Rabies occurs in more than 150 countries and territories, resulting in at least 55,000 human deaths per year worldwide according to World Health Organization estimates. Rabies is a vaccine-preventable viral disease caused by numerous lyssaviruses that are found in a variety of animal species throughout the world. Rabies virus infects the central nervous system, causing disease in the brain with almost 100% mortality once clinical symptoms manifest.

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.

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 researchers have developed improved Loop-Mediated Isothermal Amplification (LAMP) assays for the nucleic acid-based diagnosis of malaria in field settings. The approach employs Plasmodium genus-specific LAMP primers and a portable tube scanner to run the LAMP reaction and measure fluorescence signal (e.g., SYBR green) as a measure of DNA amplification in real time. Using this platform, the researchers were able to detect several different species of the human malaria parasites.

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 researchers have identified and characterized discrete flavivirus cross-reactive epitopes useful for improving serodiagnosis and vaccination of flaviviruses, such as dengue virus, yellow fever virus, Japanese encephalitis virus, West Nile virus and the tick-borne encephalitis viruses.

CDC researchers have developed a bead-based nucleic acid assay for serotyping members of the Salmonella genus; this assay will identify serotypes for approximately 95% of all human-obtained Salmonella isolates in the United States.

This CDC-developed technology entails novel compositions and methods related to the diagnosis of Lyme disease. Lyme disease, caused by the Borrelia burgdorferi bacterium, is the most common tick-borne infectious disease in the US and Europe. Diagnosis of Lyme disease is particularly challenging as symptoms often appear long after exposure. At present, the only FDA-approved diagnostic for Lyme disease involves patient blood tests for particular antibodies; these include an ELISA to measure patient antibody levels and a Western blot assay to detect antibodies specific to B.