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

NCT04474132 | Recruiting DMC FDA Device

• 1 other identifier: IRB20-0442
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Toxoplasma Infections

Keywords

toxoplasma; test; feasibility

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

single group

OTHER

binary: positive or negative result

Device: toxoplasma ICT IgG-IgM BK

Interventions

toxoplasma ICT IgG-IgM BK DEVICE

a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody

single group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any adult who is willing to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 30114251 RESULT

• 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.

  PMID: 28650970 RESULT

• 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.

  PMID: 30393749 RESULT

• Zhou Y, Leahy K, Grose A, Lykins J, Siddiqui M, Leong N, Goodall P, Withers S, Ashi K, Schrantz S, Tesic V, Abeleda AP, Beavis K, Clouser F, Ismail M, Christmas M, Piarroux R, Limonne D, Chapey E, Abraham S, Baird I, Thibodeau J, Boyer KM, Torres E, Conrey S, Wang K, Staat MA, Back N, L'Ollivier C, Mahinc C, Flori P, Gomez-Marin J, Peyron F, Houze S, Wallon M, McLeod R. Novel paradigm enables accurate monthly gestational screening to prevent congenital toxoplasmosis and more. PLoS Negl Trop Dis. 2024 May 28;18(5):e0011335. doi: 10.1371/journal.pntd.0011335. eCollection 2024 May.

  PMID: 38805559 DERIVED

Study Officials

• Rima McLeod, M.D.

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rima McLeod, M.D.

CONTACT

312-513-6365; rmcleod@uchicago.edu

Marcela Cid

CONTACT

714-376-4412; mcidrosas@uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: August 13, 2020
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)