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

Recruiting now · Not applicable

Conditions studied: Toxoplasma Infections

In brief

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.

Key facts

Study ID

NCT04474132

Run by

University of Chicago

People needed

210

Starts

2020-08-13

Expected to finish

2026-08-20

Last updated by the study team

2025-09-02

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• any adult who is willing to participate in the study

You may not qualify if…

• pregnant women who are in their 17-27 weeks of gestation.

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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