Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
NCT04474132
This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Toxoplasma Infections
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Sponsor
- University of Chicago
- Last updated on ClinicalTrials.gov
- September 2, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Illinois · 1
- University of Chicago · Chicago, IL
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.