Encapsulated Streptococcus Compositions and Methods for Pneumococcal Vaccine, Probiotic, and Diagnostic Assay Development

Streptococcus pneumoniae (S. pneumoniae) bacteria, or pneumococcus, can cause many types of illnesses. These range from ear and sinus infections to life-threatening conditions such as pneumonia, bloodstream infections, and meningitis. Pneumococci are surrounded by a polysaccharide capsule, which is thought to help it evade the immune system. Presently, over 90 known serotypes of S. pneumoniae have been identified, of which only a minority produce the majority of pneumococcal infections; a serotype is defined by a unique pneumococcal capsule structure.

One-Step Random Amplification Method to Detect Extremely Low Input Nucleic Acids for Virome, Microbiome, and Metagenomics in Clinical and Biological Specimens

Clinical and biological specimens often contain microbial nucleic acid in extremely low quantities, presenting a significant challenge for the detection of viral and bacterial pathogens. This also prevents direct sequencing of non-culturable samples using next-generation sequencing (NGS). Currently, NGS library preparation on most platforms requires 0.1 ng to 10 µg of DNA or cDNA, while microbial or viral nucleic acids in clinically relevant specimens, such as blood, serum, respiratory secretions, cerebral spinal fluid, and stool, often contain less than 0.1 ng.

Hybridomas to Human Immunoglobulins for SARS-CoV-2 Diagnostics and Additional Indications

Immunoglobulins play a key role in the immune system. CDC has developed and tested hybridoma cell lines (monoclonal antibody (mAb) clones) for human IgG and other immunoglobulins. The mAbs generated from those hybridomas could be used as a reagent (second Ab) of anti-human immunoglobins in a diagnostic assay for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes COVID-19 (coronavirus disease 2019) and other assays that detect antigen specific antibodies from human sera.

Diagnostic Assay to Detect Group C Rotavirus in Humans and Animals—Monoclonal Antibody-based ELISA (Enzyme-linked Immunosorbent Assay)

Rotaviruses cause severe gastroenteritis in humans and animals globally. Currently, there are eight known serogroups (A-H) of rotaviruses. Group C rotavirus (GpC RV) causes sporadic cases and outbreaks of acute diarrhea in children and adults worldwide. GpC RV is also associated with diarrhea in swine. Currently, no simple and reliable diagnostic test exists for GpC RV, so disease prevalence remains unknown.

A Diagnostic Kit for Assessing Exposure or Infection by the Koala Family of Retroviruses

This invention relates to a diagnostic kit for assessing exposure to or infection by a koala retrovirus. The kit consists of specific primers and probes for the detection of three distinct subtypes of infectious koala retrovirus and may be useful in various species, including humans, primates, and koalas.

Multiplexing Homocysteine in Primary Newborn Screening Assays Using Maleimides as Select Derivatization Agents

Homocystinuria (HCU), a group of inherited disorders, causes symptoms ranging from failure to thrive and developmental delays in infants or young children to abnormal blood clots with onset in adults.1 Approximately 1 in 200,000 to 335,000 people have HCU globally.2

A Rapid Method for Producing Antibodies

Antibodies are specialized proteins produced by the immune system which target and neutralize foreign materials, such as viruses or bacteria. Antibodies have a variety of useful applications in diagnostics, therapeutics, and as research reagents. Despite their widespread use there is no standard method to produce antibodies, and currently available methods are labor and time intensive.

Novel Inactivated Zika Vaccine Candidate Based on Purified Wild-type Zika Virus — for Zika Vaccine and Diagnostic Assay Development

Zika virus (ZIKV) spreads to people primarily through bite by infected Aedes mosquitoes. ZIKV infection during pregnancy can cause stillbirths or affect the fetus by causing serious birth defects, such as microcephaly and other brain defects. Although uncommon, adults with ZIKV can also develop Guillain-Barre syndrome and other neurological disorders. According to the World Health Organization’s July 2019 report, a total of 87 countries and territories have had evidence of mosquito-borne transmission of ZIKV.

Monoclonal Antibodies for Detection of Stachybotrys chartarum (a Fungus)

CDC NIOSH researchers have developed a simple and rapid detection technique for Stachybotrys chartarum (a type of mold that commonly grows on wet building materials) by producing monoclonal antibodies which reacts with proteins in Stachybotrys chartarum. These antibodies can be used in immunologic detection assays to detect and possibly quantify Stachybotrys chartarum in environmental samples, and to our knowledge, they do not cross react with other fungi.

Nucleic Acid Detection of the Fungal Pathogen Histoplasma capsulatum from Clinical and Environmental Samples

This invention relates to detecting Histoplasma capsulatum by PCR using oligonucleotide probes specific for the fungus. Histoplasmosis is a mycotic infection of varying severity, usually localized in the lungs. Caused by H. capsulatum, infections are usually symptomatic but can develop into chronic disease, especially in immunocompromised individuals.