TY - JOUR
T1 - Use of a Latent Class Analysis in the Diagnosis of Chronic Chagas Disease in the Washington Metropolitan Area
AU - Castro-Sesquen, Yagahira E.
AU - Saldaña, Antonella
AU - Patino Nava, Dhayanna
AU - Bayangos, Tabitha
AU - Paulette Evans, Diana
AU - Detoy, Kelly
AU - Trevino, Alexia
AU - Marcus, Rachel
AU - Bern, Caryn
AU - Gilman, Robert H.
AU - Talaat, Kawsar R.
N1 - Funding Information:
Potential conflicts of interest. Y. E. C.-S. reports nonfinancial support from InBios International Inc. during the conduct of the study and outside the submitted work. C. B. reports grants from Mundo Sano Foundation, personal fees from UpToDate, both outside the submitted work. R. H. G. reports grants, nonfinancial support and other from InBios International during the conduct of the study and outside the submitted work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.
Publisher Copyright:
© 2020 The Author(s). Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - Background: The diversity of individuals at risk for Trypanosoma cruzi infection in the United States poses challenges for diagnosis. We evaluated the diagnostic accuracy of Food and Drug Administration (FDA)-cleared tests in the Washington Metropolitan area (WMA). Methods: In total, 1514 individuals were evaluated (1078 from Mexico, Central and northern South America [TcI-predominant areas], and 436 from southern South America [TcII/V/VI-predominant areas]). Optical density (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 2 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 <. 001, 93.1%, P =. 014, and 84.9%, P =. 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% confidence interval [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. Conclusions: 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 United States.
AB - Background: The diversity of individuals at risk for Trypanosoma cruzi infection in the United States poses challenges for diagnosis. We evaluated the diagnostic accuracy of Food and Drug Administration (FDA)-cleared tests in the Washington Metropolitan area (WMA). Methods: In total, 1514 individuals were evaluated (1078 from Mexico, Central and northern South America [TcI-predominant areas], and 436 from southern South America [TcII/V/VI-predominant areas]). Optical density (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 2 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 <. 001, 93.1%, P =. 014, and 84.9%, P =. 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% confidence interval [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. Conclusions: 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 United States.
KW - Chronic Chagas disease
KW - Latent class analysis
KW - Latin American immigrants
KW - Serodiagnosis
KW - Test accuracy
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U2 - 10.1093/cid/ciaa1101
DO - 10.1093/cid/ciaa1101
M3 - Article
C2 - 32766826
AN - SCOPUS:85106068935
SN - 1058-4838
VL - 72
SP - E303-E310
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 9
ER -