Actively Recruiting
Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
Led by University of Chicago · Updated on 2025-09-02
210
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any adult who is willing to participate in the study
You will not qualify if you...
- Pregnant women who are in their 17-27 weeks of gestation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
R
Rima McLeod, M.D.
CONTACT
M
Marcela Cid
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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