Toxoplasma Infections
Conditions
Keywords
toxoplasma, test, feasibility
Brief 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.
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
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| congruence of Toxoplasma ICT IgG-IgM test and standard predicate test | 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 |
Countries
United States
Contacts
Primary ContactRima McLeod, M.D.
Backup ContactMarcela Cid
Outcome results
None listed