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Diagnostic Assays for early Lyme Borreliosis using in-vivo expressed antigens

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI096598-02
Agency Tracking Number: R44AI096598
Amount: $1,655,122.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA13-234
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-07-01
Award End Date (Contract End Date): 2016-06-30
Small Business Information
BOX 8175
New Haven, CT 06530-0175
United States
DUNS: 142406110
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (203) 507-5304
Business Contact
Phone: (203) 393-9439
Research Institution

DESCRIPTION provided by applicant Current testing for Lyme disease is suboptimal because it requires two assay platforms including one with subjective interpretation of results and because it has lower sensitivity in the early stage of the illness Infection with Borrelia burgdorferi the causative agent of Lyme disease is transmitted by the bite of an Ixodid tick and results in uniformly low pathogen burdens with only a transient bloodborne phase so that the sensitivity of direct detection assays of the bacteria in easily accessible tissues such as the blood is low Diagnostic testing therefore relies on serologic assays to detect antibodies to the bacteria The CDC currently recommends a two tier assay with an initial ELISA and positive or equivocal results must be confirmed by immunoblot Historically both assays were performed with whole cell sonicate of in vitro cultured bacteria even though it is now known that B burgdorferi spirochetes alter their protein expression when they move from the tick to the mammalian host and when they are cultured in vitro More recently an ELISA for the C peptide from the VlsE protein has been developed and is now sometimes used instead of the lysate ELISA The results of this assay which is based on just one antigen are still often confirmed by immunoblot that is time consuming subjective and expensive We have developed a new one step rapid multiplex assay using the Luminex xMAP Technology platform that improves upon both the assay platform of the current tests and the antigens used We identified a panel of antigens that are expressed by spirochetes within the mammalian host and to which early IgG responses are generated We have developed a multiplex assay that has a much larger dynamic range than ELISA or immunoblot and can be completed more rapidly and objectively The use of multiple but specific antigens also obviates the need for two tier testing Preliminary results from our Phase I study also suggest that our assay has improved sensitivity for detecting early infections particularly when the current assays fail PUBLIC HEALTH RELEVANCE Lyme disease is the most common vector borne disease in the United States and is a major public health concern Current tests for Lyme disease require multiple stages that take up to a week to complete and are not sensitive during the early stages of infection We have developed a new rapid one step test that overcomes many of the problems with the currently available tests Our primary objective is to determine how well our assay works compared to current tests

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

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