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Cleavage Coupled Lateral Flow Immunoassay for Rapid Endotoxin Testing

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI118147-01
Agency Tracking Number: R43AI118147
Amount: $214,428.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA14-071
Solicitation Year: 2015
Award Year: 2015
Award Start Date (Proposal Award Date): 2015-03-01
Award End Date (Contract End Date): 2016-08-31
Small Business Information
San Diego, CA 92122-4126
United States
DUNS: 068800915
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (858) 455-9976
Business Contact
Phone: (858) 248-9253
Research Institution

DESCRIPTION provided by applicant Bacterial endotoxins namely lipopolysaccharide LPS are common contaminants of many pharmaceutical medical device and food products that can elicit very strong immune responses in people and animals sometimes resulting in septic shock As such monitoring for endotoxin in medical and food products is essential and a $ billion annual market Current methods for detecting endotoxin are complex expensive and difficult to standardize Hence there is an unmet need for rapid simple assays that can be used to quickly assess endotoxin levels in field or point of care settings Lateral flow based assays LFAs are ideally suited for end users that require frequent rapid and straightforward endotoxin testing LFAs require very little sample no equipment or additional reagents and are simple robust and produced for $ each at scale We will develop a novel cleavage coupled competitive lateral flow assay C LFA that will enable inexpensive lateral flow devices that require no external instrumentation or skilled personnel to use The basis of the assay technology is a novel peptide construct that incorporates the cleavage site for an endotoxin activated protease between mimetope peptides that are specifically recognized by a particular monoclonal antibody The intact dimer form of this construct has high affinity for the antibody but the monovalent affinity of the cleaved form is considerably weaker Thus activity can unmask the antibodyandapos s antigen binding sites previously blocked by the dimer peptide construct by cleavage to low affinity monomers The specific aims of this Phase I application are to Optimize the dimer peptide and Develop the LPS C LFA prototype The long term goal of this project is to develop lateral flow immunoassays that can rapidly determine endotoxin levels above or below set thresholds We have previously developed these mimetope peptides as lateral flow based sensors for their cognate antibody and are thus well poised to leverage that technique for the unique problem of enzyme activity via lateral flow PUBLIC HEALTH RELEVANCE Bacterial endotoxins are common contaminants of many drugs medical devices and food products that can trigger very strong immune responses in people and animals sometimes resulting in septic shock We will develop a rapid simple and low cost lateral flow test that anyone can use to quickly monitor endotoxin levels in field or point of care settings with no need for equipment or additional reagents

* Information listed above is at the time of submission. *

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