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 - 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 -