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

Toxoplasma Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04474132
• Other study ID #: IRB20-0442
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Toxoplasma Infections

Intervention

Device:
• toxoplasma 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

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (3)

Begeman IJ, Lykins J, Zhou Y, Lai BS, Levigne P, El Bissati K, Boyer K, Withers S, Clouser F, Noble AG, Rabiah P, Swisher CN, Heydemann PT, Contopoulos-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Stillwaggon E, Peyron F, McLeod R. Point-of- — View Citation

Gomez CA, Budvytyte LN, Press C, Zhou L, McLeod R, Maldonado Y, Montoya JG, Contopoulos-Ioannidis DG. Evaluation of Three Point-of-Care Tests for Detection of Toxoplasma Immunoglobulin IgG and IgM in the United States: Proof of Concept and Challenges. Ope — View Citation

Lykins J, Li X, Levigne P, Zhou Y, El Bissati K, Clouser F, Wallon M, Morel F, Leahy K, El Mansouri B, Siddiqui M, Leong N, Michalowski M, Irwin E, Goodall P, Ismail M, Christmas M, Adlaoui EB, Rhajaoui M, Barkat A, Cong H, Begeman IJ, Lai BS, Contopoulos — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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