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Point of Care Testing for Presence of Current and or Previous T. Gondii Infection
Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection
Who can join
Ages 18 to 90 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * any adult who is willing to participate in the study Exclusion Criteria: * pregnant women who are in their 17-27 weeks of gestation.
About the study
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.
What is being tested
- toxoplasma ICT IgG-IgM BK (device)
Sponsor: University of Chicago · Participants: 210 · Started: Aug 13, 2020
Contact the study team
- Rima McLeod, M.D. · Phone: 312-513-6365
- Marcela Cid · Phone: 714-376-4412
Official record on ClinicalTrials.gov — NCT04474132
Locations in the U.S.
| Illinois | University of Chicago, Chicago |
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.