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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
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• any adult who is willing to participate in the study

Locations
United States
Illinois
University of Chicago
RECRUITING
Chicago
Contact Information
Primary
Rima McLeod, M.D.
rmcleod@uchicago.edu
312-513-6365
Backup
Marcela Cid
mcidrosas@uchicago.edu
714-376-4412
Time Frame
Start Date: 2020-08-13
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 210
Treatments
Other: single group
binary: positive or negative result
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov