NCT04474132

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Toxoplasma Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-08-13
• Primary completion: 2026-08-20
• Completion: 2026-08-20
• First posted: 2020-07-16
• Last updated: 2025-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study