Novel UNEX Buffer and Disk for Safe Storage and Transport at Ambient Temperatures of Clinical Specimens for Molecular Testing of Pathogens

The development of genomic approaches and nucleic acid based techniques has led to a large number of biological samples, including DNA, RNA, cells, tissues, and environmental samples that require storage. Typically, microbial DNA and RNA samples are stored long-term in laboratory freezers at temperatures ranging from -20°C to -196°C, the lower ranges utilizing liquid nitrogen. This often requires the use of several freezer boxes that can take up space and become difficult to sort through.

Novel Fourth Human Ebolavirus species, <em>Bundibugyo ebolavirus</em> – Compositions and Methods for Vaccine, Therapeutics and Highly Sensitive Diagnostic Assay Development

Ebola Virus Disease (EVD) is a disease caused by infection with viruses from the family Filoviridae, genus Ebolavirus. Ebola virus was first discovered in 1976 in Africa and has since caused numerous outbreaks throughout the continent including the largest outbreak in history in West Africa during 2014-2016. Previously, there were three identified Ebolavirus species which were known to cause disease in humans: Ebola virus (Zaire ebolavirus); Sudan virus (Sudan ebolavirus); and Tai Forest virus (Tai Forest ebolavirus).

Monoclonal Antibodies for Specific Detection of Dengue Virus Sub-type 4 in Human Serum

Dengue Virus (DENV) non-structural protein 1 (NS1) is secreted in blood during the acute phase of viremic DENV infection. While there are commercially available ELISA assays for DENV NS1 detection, these tests have limited sensitivity (50-70%), do not determine the serotype of the infecting DENV, do not detect all four serotypes equally, or are less sensitive in subsequent DENV infections. There is a critical need for serotype specific diagnostics to inform public health and potentially clinical care interventions.

Zika Virus NS1 Protein Monoclonal Antibodies for Research, Development, and Novel Diagnostics

Zika virus is a flavivirus that is spread by the bite of infected Aedes mosquitoes. The current outbreak and swift dissemination/spread of Zika virus (ZIKV) and its linkage to birth defects and neurological syndromes has prompted the development of novel diagnostic tests. Because ZIKV is serologically similar to other flaviviruses such as dengue virus (DNV), cross-reactivity occurs in diagnostic tests and can result in misdiagnoses. This is especially evident in populations that live in dengue-endemic regions or have received heterologous flaviviral vaccines (i.e., yellow fever 17D).

Portable Laser-Operated Counterfeit Drug Identifier (CoDI) for Tablets

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.

West Nile/Zika Virus Chimeras for Inactivated Zika Vaccine and Diagnostic Assay Development

Zika virus (ZIKV) is a flavivirus primarily transmitted by infected Aedes mosquitoes. Infection with ZIKV during pregnancy can affect the fetus causing microcephaly, neurological complications, and other birth defects. Adults are also at risk of developing Guillain-Barre syndrome and other neurological disorders from ZIKV infection. In response to the 2015-2016 Zika outbreak, CDC researchers developed new Zika virus chimeras that can be used for inactivated Zika vaccine candidates and faster Zika antibody (Ab) neutralization assay testing.

Rapid Colorimetric Detection of Zika Virus from Serum and Urine Specimens by RT-LAMP (Reverse Transcription Loop-Mediated Isothermal Amplification).

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.

Real-Time PCR Assay for Detection of Carbapenem Antibiotic Resistance Genes of the IMP-type

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.

Real-Time RT-PCR Assay for the Rapid Detection of Rabies and Other Lyssaviruses

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.