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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Toxoplasma Infections
• Intervention / Treatment: Device: toxoplasma ICT IgG-IgM BK

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rima McLeod, M.D.; Phone Number: 7738344130; Email: rmcleod@uchicago.edu
• Study Contact Backup: Name: Ying Zhou, Ph.D.; Phone Number: 7738344120; Email: yzhou@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
      • Contact: Ying Zhou, Ph.D.; Phone Number: 7738344120; Email: yzhou@bsd.uchicago.edu
      • Contact: Rima McLeod, M.D.; Phone Number: 773-834-4130; Email: rmcleod@uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: single group; binary: positive or negative result	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Chicago

Publications and helpful links

General Publications

• 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-Ioannidis DG, Montoya JG, Maldonado Y, Ramirez R, Press C, Peyron F, McLeod R. Rapid, inexpensive, fingerstick, whole-blood, sensitive, specific, point-of-care test for anti-Toxoplasma antibodies. PLoS Negl Trop Dis. 2018 Aug 16;12(8):e0006536. doi: 10.1371/journal.pntd.0006536. eCollection 2018 Aug. No abstract available.
• 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-care testing for Toxoplasma gondii IgG/IgM using Toxoplasma ICT IgG-IgM test with sera from the United States and implications for developing countries. PLoS Negl Trop Dis. 2017 Jun 26;11(6):e0005670. doi: 10.1371/journal.pntd.0005670. eCollection 2017 Jun.
• 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. Open Forum Infect Dis. 2018 Oct 29;5(10):ofy215. doi: 10.1093/ofid/ofy215. eCollection 2018 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: feasibility; test; toxoplasma
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: IRB20-0442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No