A Point of Care Test for Babesia microti

L2 Diagnostics, Llc, New Haven CT

Investigators

Abstract

ABSTRACT Babesia microti is a parasite that is transmitted to humans by the same tick that transmits the agents of Lyme disease and human granulocytic anaplasmosis. The incidence of babesiosis due to tick bites is increasing, and it is also the most commonly reported blood transfusion-associated pathogen. Swift clinical diagnosis is paramount because patients can rapidly progress to severe infection potentially leading to acute respiratory failure, congestive heart failure, and renal failure. Rapid diagnostic tests for babesiosis do not exist. This is problematic because patients often present with flu-like symptoms, and physicians must make their initial diagnosis based on indirect clinical evidence and the patient's epidemiological risk factors. Confirmation by reference laboratory testing typically takes several days, leaving a critical window of diagnostic uncertainty. This Phase I project expands the aims of our work to develop an antigen capture ELISA that detects BmGPI12 (BmSA1), a secreted protein expressed in large amounts by the babesia parasite during active infection and released in the blood of the infected host. The goal of this project is a rapid diagnostic test (RDT) in a lateral flow assay (LFA) format that is rapid, highly sensitive and suitable for use by (i) physicians at the point of patient care for the rapid patient diagnosis, and (ii) blood collection agencies at the time of a donor blood draws to prevent Babesia entry into the donor blood supply.