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

University of Chicago · NCT04474132

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
210
US sites recruiting
1
Study start
August 13, 2020
Record last updated
September 2, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: toxoplasma ICT IgG-IgM BK

Conditions: Toxoplasma Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • University of Chicago

    Chicago, IL 60637

    Site contact: Rima McLeod, M.D. · 312-513-6365 · rmcleod@uchicago.edu

Study contacts (from the official record)

  • Rima McLeod, M.D. · 312-513-6365 · rmcleod@uchicago.edu
  • Marcela Cid · 714-376-4412 · mcidrosas@uchicago.edu
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Point of Care Testing for Presence of Current and or Previous T.… (NCT04474132) | Bored Studies