RecruitingNot ApplicableNCT04474132

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


Sponsor

University of Chicago

Enrollment

210 participants

Start Date

Aug 13, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria1

  • any adult who is willing to participate in the study

Exclusion Criteria1

  • pregnant women who are in their 17-27 weeks of gestation.

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Interventions

DEVICEtoxoplasma 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


Locations(1)

University of Chicago

Chicago, Illinois, United States

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NCT04474132