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

August 25, 2025 updated by: University of Chicago

Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will determine the feasibility of using the point of care Toxoplasma ICT IgG-IgM BK test produced by LD Bio Diagnostic to detect Toxoplasma gondii in clinical settings. The result of testing from Toxoplasma ICT IgG-IgM BK test will be compared with the standard predicate test. These results will be provided to FDA for consideration for clearance of this test.

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: single group
binary: positive or negative result
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
congruence of Toxoplasma ICT IgG-IgM test and standard predicate test
Time Frame: two weeks for initial result and a year for whole study
Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test
two weeks for initial result and a year for whole study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Rima McLeod, M.D., University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2020

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

August 20, 2026

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB20-0442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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