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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Toxoplasma Infections

Intervention / Treatment
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* Device: toxoplasma ICT IgG-IgM BK


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: subjects are recruited continuously and being tested with the study device as well as with the standard cleared test for the presence of Toxoplasma gondii antibody.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single group<br>binary: positive or negative result | Device: toxoplasma ICT IgG-IgM BK<br>* a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| congruence of Toxoplasma ICT IgG-IgM test and standard predicate test | Toxoplasma ICT IgG-IgM test is feasible and the test result of the study device is same with the result of standard cleared test | two weeks for initial result and a year for whole study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toxoplasma, test, feasibility