A point of care test for babesia microti

The National Institute of Allergy and Infectious Diseases awarded L2 Diagnostics LLC $567,852 on September 21, 2025, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to develop a rapid diagnostic test for Babesia microti infection.

L2 Diagnostics is developing a point-of-care lateral flow assay that detects BMGPI12 (BMSA1), a secreted protein expressed by the Babesia parasite during active infection. The test is intended for use by physicians at the point of patient care and by blood collection agencies at donor blood draws to prevent Babesia entry into the blood supply. Current diagnostic confirmation through reference laboratory testing takes several days, creating a critical window of diagnostic uncertainty; rapid diagnostic tests for babesiosis do not currently exist.

This is a Phase I Small Business Innovation Research award. The period of performance runs through August 31, 2027, with performance taking place in New Haven, Connecticut. L2 Diagnostics LLC is a for-profit limited liability company based in Woodbridge, Connecticut, specializing in biomedical research and development of diagnostics, therapeutics, and vaccines for infectious diseases, particularly tick-borne pathogens.

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.