Point-of-care test for current or past Toxoplasma gondii infection
Official title: Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection
Run by University of Chicago · NCT04474132 · Data updated 2026-11-12
This project will test a rapid point-of-care blood test to see if it can detect current or past Toxoplasma infection in adults, including pregnant people.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | August 13, 2020 |
| Main results expected | August 20, 2026 |
| Study ends | August 20, 2026 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT04474132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults willing to provide blood samples, including pregnant and non-pregnant people, except pregnant people between 17 and 27 weeks' gestation who are excluded.
✕Probably not a fit
Children, adults unwilling to provide blood samples, and pregnant people in the 17–27 week window are not eligible and would not receive direct benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This feasibility effort compares the LD Bio Diagnostic Toxoplasma ICT IgG-IgM BK point-of-care test to a standard FDA-cleared predicate assay using both serum and whole blood. About 70 adults, including pregnant and non-pregnant participants but excluding pregnant people at 17–27 weeks' gestation, will provide samples for parallel testing. Sensitivity and specificity will be calculated for serum and fingerstick/whole-blood specimens, and results will be provided to the FDA to support potential 510(k) clearance and a dual CLIA waiver. The work is conducted at the University of Chicago clinical site.
Why it matters
Potential benefit: If successful, a cleared point-of-care test could give faster, clinic-based detection of Toxoplasma infection and help speed counseling and management.
How similar studies have gone: Similar rapid immunochromatographic IgG/IgM tests for Toxoplasma have shown promising sensitivity and specificity in prior research, though whole-blood point-of-care performance is less well established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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University of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Rima McLeod, M.D. — University of Chicago
- Study coordinator: Rima McLeod, M.D.
- Email: rmcleod@uchicago.edu
- Phone: 312-513-6365
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.