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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• congruence of Toxoplasma ICT IgG-IgM test and standard predicate test [Срок оценки: two weeks for initial result and a year for whole study]

Критерии участия

Критерии включения

• any adult who is willing to participate in the study

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• University of Chicago — Chicago

Публикации

• 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 PMID 30114251
• 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 cou PMID 28650970
• 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
• 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 accu PMID 38805559

Идентификаторы

NCT: NCT04474132 · IRB20-0442

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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