Point of Care Testing for Presence of Current and or Previous T. Gondii Infection

Study overview

This is part of a feasibility study to compare the predicate standard FDA cleared test for serum to a point of care test Toxoplasma ICT IgG-IgM BK produced by LD Bio Diagnostic. The specificity and sensitivity in testing serum and whole blood will be compared. This study includes 70 persons either pregnant or non pregnant. This is being done in accordance with FDA requirements for clearance of a testing device . The investigators will use a standard FDA cleared test in all studies. The FDA has suggested that the investigators submit a pre subQ for a 510K and dual CLIA waiver. This allows the investigators also to determine feasibility of use of the predicate test in conjunction with the experimental test with volunteers, including men, women, and pregnant women.

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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Collaborators and Investigators

University of Chicago,

Rima McLeod, M.D., PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2026-08-20