Use of a Latent Class Analysis in the diagnosis of chronic Chagas disease in the Washington Metropolitan area.

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Citation: Clinical Infectious Diseases. 2020 Aug 07PMID: 32766826Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: IN PROCESS -- NOT YET INDEXEDYear: 2020ISSN:
  • 1058-4838
Name of journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaAbstract: BACKGROUND: The diversity of individuals at risk for Trypanosoma cruzi infection in the U.S. poses challenges for diagnosis. We evaluated the diagnostic accuracy of FDA-cleared tests in the Washington Metropolitan area (WMA).CONCLUSION: Deficiencies in current FDA-cleared assays were observed. Low antibody levels are the main type of seropositives in individuals from TcI-predominant areas, the most frequent immigrant group in the U.S. Copyright (c) The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected]: 1514 individuals living were evaluated (1078 from Mexico, Central and northern South America [TcI-predominant areas], and 436 from southern South America [TcII/V/VI-predominant areas]). OD values from the Hemagen EIA and Chagatest v.3 Wiener, and categorical results of the IgG-TESA-blot (Western Blot with Trypomastigote Excretory-Secretory Antigen), and the Chagas Detect Plus (CDP), as well as information of area of origin were used to determine T. cruzi serostatus using Latent Class Analysis.RESULTS: We detected two latent class (LC) of seropositives with low (LC1) and high (LC2) antibody levels. A significantly lower number of seropositives were detected by the Wiener, IgG-TESA-blot, and CDP in LC1 (60.6%, p<0.001, 93.1%, p=0.014, and 84.9%, p=0.002, respectively) as compared to LC2 (100%, 100%, and 98.2%, respectively). LC1 was the main type of seropositives in TcI-predominant areas, representing 65.0% of all seropositives as opposed to 22.8% in TcII/V/VI-predominant areas. The highest sensitivity was observed for the Hemagen (100%, 95% CI: 96.2-100.0), but this test has a low specificity (90.4%, 95% CI: 88.7-91.9). The best balance between positive (90.9%, 95% CI: 83.5-95.1), and negative (99.9%, 95% CI: 99.4-99.9) predictive values was obtained with the Wiener.All authors: Bayangos T, Bern C, Castro-Sesquen YE, Chagas Working Group in Peru and the U.S., DeToy K, Gilman RH, Marcus R, Patino Nava D, Paulette Evans D, Saldana A, Talaat KR, Trevino AFiscal year: FY2021Digital Object Identifier: Date added to catalog: 2020-09-02
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Journal Article MedStar Authors Catalog Article 32766826 Available 32766826

BACKGROUND: The diversity of individuals at risk for Trypanosoma cruzi infection in the U.S. poses challenges for diagnosis. We evaluated the diagnostic accuracy of FDA-cleared tests in the Washington Metropolitan area (WMA).

CONCLUSION: Deficiencies in current FDA-cleared assays were observed. Low antibody levels are the main type of seropositives in individuals from TcI-predominant areas, the most frequent immigrant group in the U.S. Copyright (c) The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: [email protected].

METHODS: 1514 individuals living were evaluated (1078 from Mexico, Central and northern South America [TcI-predominant areas], and 436 from southern South America [TcII/V/VI-predominant areas]). OD values from the Hemagen EIA and Chagatest v.3 Wiener, and categorical results of the IgG-TESA-blot (Western Blot with Trypomastigote Excretory-Secretory Antigen), and the Chagas Detect Plus (CDP), as well as information of area of origin were used to determine T. cruzi serostatus using Latent Class Analysis.

RESULTS: We detected two latent class (LC) of seropositives with low (LC1) and high (LC2) antibody levels. A significantly lower number of seropositives were detected by the Wiener, IgG-TESA-blot, and CDP in LC1 (60.6%, p<0.001, 93.1%, p=0.014, and 84.9%, p=0.002, respectively) as compared to LC2 (100%, 100%, and 98.2%, respectively). LC1 was the main type of seropositives in TcI-predominant areas, representing 65.0% of all seropositives as opposed to 22.8% in TcII/V/VI-predominant areas. The highest sensitivity was observed for the Hemagen (100%, 95% CI: 96.2-100.0), but this test has a low specificity (90.4%, 95% CI: 88.7-91.9). The best balance between positive (90.9%, 95% CI: 83.5-95.1), and negative (99.9%, 95% CI: 99.4-99.9) predictive values was obtained with the Wiener.

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