Assay for Early Diagnosis of Anthrax Using Monoclonal Antibodies Against Anthrax Toxin

Anthrax is a serious infectious disease caused by bacteria known as Bacillus anthracis. Anthrax-contaminated spores can be found naturally in soil and they commonly affect domestic and wild animals around the world. Although rare in the United States, people can get sick with anthrax if they come in contact with infected animals or contaminated animal products.

Method to Remove Mycoplasma Contamination from Virus Stocks

Mycoplasma are a form of bacteria that are commonly found as contaminants in cell cultures. They adversely affect cell line growth rates and viral vaccine production. Mycoplasma contamination is a challenge for the vaccine industry and virology researchers. Current commercial reagents or kits only temporarily inhibit the growth of mycoplasma, but cannot eliminate the contaminants.

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.

Personalized Cancer Evaluation (PERCEVAL) Method and Software

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).

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).

Heartland Virus Humanized Monoclonal Antibodies for Diagnostic and Therapeutic Development

Heartland virus (HRTV) is a novel tick-borne virus first discovered in 2009 that causes flu-like symptoms such as fever, headaches, fatigue, muscle aches, and diarrhea. Patients with HRTV often have low white blood cell counts, low platelet counts, and abnormal liver function tests which can become severe. Cases of Heartland virus disease have been identified in the Midwestern and southern United States. There are no vaccines to prevent or medications to treat Heartland virus infections.

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.