L2 DIAGNOSTICS LLC — Department of Health and Human Services STTR Phase I: NIAID

Description

ABSTRACT Borrelia miyamotoi is a tick transmitted spirochete recently shown to cause infection and disease in the United StatesEurope and AsiaA member of the relapsing fever group of Borreliathis pathogen has been proven to cause most commonly a nonspecificflu like illness with feverfatiguemyalgiaand headacheDisease can be particularly severe and involve the central nervous system in immunocompromised patientsThe true extent of disease due to this bacterium is difficult to assess because of the lack of a fully validated diagnostic assayConverselydevelopment of a clinically useful test is difficult because of the lack of a large cohort of clinically well characterized patients infected with BmiyamotoiWe have access to two populations of well characterized patients from which we can identify cases of active diseaseOur goal over Phases I and II of this project is to assemble a collection of up toserum samples from patients known to have been exposed to and or infected with BmiyamotoiThe first cohort of patients consists of individuals who have been bitten by ticks and who have submitted these ticks for analysis to our collaborator DrRichIf the tick is found to be infected with Borrelia miyamotoiwe will contact the patient and obtain blood and serum samplesThe second group of patients will consist of individuals who consulted their healthcare professional with symptoms of febrile illness in the spring and summer and who are suspected of having a tickborne illnessWe have developed a prototype multiplexed serological assay for Borrelia miyamotoi infection based on seven published or proprietary antigensWe propose to validate this assay by analyzing serum samples from both cohorts of infected patientsStatistical methods will be used to identify the most useful diagnostic antigens and to develop an algorithm optimizing the sensitivity and specificity of the assayPatients infected with Borrelia miyamotoi will be identified by a PCR reaction that is positive for this pathogenor by evidence of seroconversion between acute and convalescent samplesA statistical approach will allow us to identify those antigens that are diagnostically informative and to develop validated criteria to correctly diagnose Bmiyamotoi infection using our multiplex assay