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

Not Applicable

Active, not recruiting

• Conditions: Toxoplasma Infections
• Interventions: Device: toxoplasma ICT IgG-IgM BK

• Registration Number: NCT04474132
• Lead Sponsor: University of Chicago

Brief 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.

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 Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2020-08-13
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single group	toxoplasma ICT IgG-IgM BK	binary: positive or negative result

Primary Outcome Measures

Name	Time	Method
congruence of Toxoplasma ICT IgG-IgM test and standard predicate test	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

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States