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

NCT04474132 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-09-02

No results posted yet for this study

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.

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

  • Toxoplasma Infections

Interventions

DEVICE

toxoplasma ICT IgG-IgM BK

a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Rima McLeod, M.D. · University of Chicago

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2026-08-20
Completion
2026-08-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474132 on ClinicalTrials.gov