University of Chicago
Chicago, Illinois, 60637, United States
Location status: Recruiting
Location contact
Marcela Cid
CONTACT
Rima McLeod, M.D.
CONTACT
Recruiting
NCT Number: NCT04474132
Point of Care Testing for 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–90 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
toxoplasma ICT IgG-IgM BK
Devicea point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody
Primary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Marcela Cid
CONTACT
Rima McLeod, M.D.
CONTACT
Sponsors and collaborators
Lead sponsor
University of Chicago
Other
Registry information
Official study title
Feasibility Study for Finger Prick Testing of Presence of Current and or Previous T. Gondii Infection
Important dates
- Study start
- 2020
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 16, 2020
- Registry last updated
- Sep 2, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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