BLACKSBURG, VA, United States
BLACKSBURG, VA, United States

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Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 599.26K | Year: 2012

DESCRIPTION (provided by applicant): The NIAID Category B priority pathogen Entamoeba histolytica is a public health threat, especially as a cause of diarrhea in travelers to and immigrants from endemic areas, men who have sex with men, and children in thedeveloping world where it is in the top 5 causes of severe diarrhea. It is also a biodefense threat to water and food supplies due to its resistance to chlorination and low infectious dose. Here we propose to develop a point-of-care (POC) fecal antigen diagnostic test. Successful completion of the project will produce the first POC test that detects E. histolytica in both fresh and formalin-fixe specimens]. Investigators: Dr. Herbein at TechLab is an expert in developing enteric diagnostics; having directed the FDA- clearance of diagnostics for Giardia and Cryptosporidia and having served as the PI for multiple Phase I/II SBIR/STTR projects. Dr. Petri at the University of Virginia is an international leader in clinical and basic investigation of amebiasis,and in collaboration with TechLab has developed the only FDA 510(k)-cleared diagnostic test for E. histolytica. [Innovation: Innovative aspects include: (1) development and manufacture of a POC test for amebiasis that can be multiplexed with that of othercategory B enteric parasites; and (2) production of the first diagnostic test for E. histolytica detection in both fresh and formalin-fixed samples]. [Approach: The following two Specific Aims are proposed to accomplish our goal of a new diagnostic test for amebiasis: 1) Produce monoclonal and polyclonal antibodies against the highly abundant Jacob protein of the E. histolytica cyst. 2) Apply these antibodies to produce a POC test for E. histolytica]. Environment: The proposal builds on the longstanding partnership of Dr. Petri at the University of Virginia with Dr. Herbein of TechLab, Inc. for amebiasis diagnostic test development. These two institutions are importantly only two hours apart and that have worked together successfully for over a decade.PUBLIC HEALTH RELEVANCE: Entamoeba histolytica is a biodefense threat and an important cause of diarrhea in: (a) travelers to, and immigrants from, endemic areas; (b) in men who have sex with men; and (c) in children in the developing world. We propose to produce a point-of-care assay for amebiasis that is rapid and easy to use, and that specifically detects E. histolytica (and not the non-pathogen E. dispar) in both fresh and fixed stool specimens.]


Patent
Techlab, Inc. | Date: 2016-06-16

The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.


Accurate and rapid differentiation of the outbreak strain ribotype 027 from other possible Clostridium difficile (C. difficile) strains, using stool samples, facilitates decision making for treatment options. Cell wall protein V (CwpV) contains a cell wall binding domain conserved among C. difficile strains and a variable domain which is antigenically different among C. difficile strains. In embodiments, antibodies against the 027-specific region in CwpV are used in diagnostic tests to detect ribotype 027 in culture or fecal samples.


Clostridium difficile disease involves a range of clinical presentations ranging from mild to self-limiting diarrhea to life-threatening pseudomembranous colitis and megacolon. Cases of C. difficile are treated differently depending on severity of disease. Mild and moderate cases may be treated with metronidazole while moderate-to-severe and relapsing cases are often treated with vancomycin or fidaxomicin. The presence of C. difficile disease is detected using a biomarker panel that includes C. difficile antigen (GDH), toxins A and B, and fecal lactoferrin. In patients suspected of C. difficile disease, if GDH is detected indicating the presence of C. difficile, and then toxins A and/or B are detected to indicate toxigenic C. difficile and support a diagnosis of C. difficile-associated disease, fecal lactoferrin concentrations are measured to determine severity of the disease by indicating the amount of intestinal inflammation.


Patent
Techlab, Inc. | Date: 2013-01-23

The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.


Patent
Techlab, Inc. | Date: 2015-01-27

The present invention provides assays and devices for detection of substances in liquid samples. The assays and devices utilize passive diffusion between a porous material and a porous membrane containing a specific binding pair member to enable detection of the substance of interest.


Nucleic acid amplification tests have been widely used in clinical laboratories. Nucleic acid extraction from biological materials is challenging because different unfavorable substances may co-extract and inhibit downstream applications. The present invention relates to a composition of and a method for treating the sample prior, during or post extraction of nucleic acid. More specifically, the claimed invention relates to a composition of and a method for using low concentrations of common organic solvents to remove inhibitors of nucleic acid amplification. The present invention can be used for extracting nucleic acids (DNA/RNA) from bacteria, viruses, parasites, and other biological materials or matrices, including but not limit to, stool samples, body fluids, plants and cultures. The method is rapid, low-cost, and easy to use in a laboratory setting. The nucleic acid extracted in accordance with the invention can be used for nucleic acid amplification reactions.


Patent
Techlab, Inc. | Date: 2016-02-17

The present invention discloses a device for detecting at least one substance of interest in a liquid sample, the device comprising:(a) a receptacle comprising a porous material for receiving the liquid sample, wherein the porous material is capable of absorbing and transmitting at least a portion of the liquid sample, and(b) a porous membrane that comprises a specific binding pair member that is specific for the substance of interest or a substance bound to the substance of interest, wherein the specific binding pair member is an antibody,wherein the receptacle and porous membrane are each shaped to permit the porous membrane to be in direct contact with the porous material over at least a portion of the porous membrane that comprises the specific binding pair member,wherein the porous material is in physical contact with a bottom side of the porous membrane comprising the specific binding pair member, the specific binding pair member being located above the porous material, the porous membrane being in direct contact with the porous material at a site where the specific binding pair member is located.


Accurate and fast detection of the presence of Campylobacter disease is important for the proper treatment of patients with Campylobacter infection. Present tests depend upon culture of viable bacteria and identification by microscopy, which requires care, skill, and two or more days for conclusive results. The current invention improves the ease of use and overcomes the limitations of loss of viability and delay inherent in Campylobacter bacterial culture and provides a more rapid alternative for the identification and diagnosis of Campylobacter and campylobacteriosis. The invention provides a new method of detecting Campylobacter by utilizing an outer membrane protein (OMP 18) to develop antibodies for use in immunoassays of bacterial cultures or human fecal samples.


Accurate and fast detection of the presence of Campylobacter disease is important for the proper treatment of patients with Campylobacter infection. Present tests depend upon culture of viable bacteria and identification by microscopy, which requires care, skill, and two or more days for conclusive results. The current invention improves the ease of use and overcomes the limitations of loss of viability and delay inherent in Campylobacter bacterial culture and provides a more rapid alternative for the identification and diagnosis of Campylobacter and campylobacteriosis. The invention provides a new method of detecting Campylobacter by utilizing an outer membrane protein (OMP 18) to develop antibodies for use in immunoassays of bacterial cultures or human fecal samples.

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