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Optimization and evaluation of the ARCHITECT Chagas assay and in-house ELISA for Chagas disease in clinical settings in Japan.

Authors
  • Imai, Kazuo1
  • Murakami, Takashi2
  • Misawa, Kazuhisa3
  • Fujikura, Yuji3
  • Kawana, Akihiko3
  • Tarumoto, Norihito1
  • Maesaki, Shigefumi1
  • Maeda, Takuya4
  • 1 Department of Infectious Disease and Infection Control, Saitama Medical University, Saitama, Japan; Center for Clinical Infectious Diseases and Research, Saitama Medical University, Saitama, Japan. , (Japan)
  • 2 Department of Microbiology, Saitama Medical University, Saitama, Japan. , (Japan)
  • 3 Department of Infectious Diseases and Respiratory Medicine, National Defense Medical College, Saitama, Japan. , (Japan)
  • 4 Center for Clinical Infectious Diseases and Research, Saitama Medical University, Saitama, Japan; Department of Laboratory Medicine, Saitama Medical University, Saitama, Japan. Electronic address: [email protected] , (Japan)
Type
Published Article
Journal
Parasitology international
Publication Date
Feb 01, 2021
Volume
80
Pages
102221–102221
Identifiers
DOI: 10.1016/j.parint.2020.102221
PMID: 33137505
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Approximately 250,000 immigrants from Latin America live in Japan and it is estimated that 1500-3000 of them are potentially infected with Trypanosoma cruzi, the cause of Chagas disease. Therefore, the establishment of a standardized diagnostic method for Chagas disease in Japan is urgently needed. In this study, we optimized and evaluated the ARCHITECT Chagas assay and in-house ELISA for Chagas disease in clinical settings. In particular, we evaluated the performance of ARCHITECT Chagas as well as ELISA with whole-cell lysates and three recombinant proteins (TcF, TcBCDE, and CP1 + CP3) using 93 Chagas disease-positive serum samples and 108 Chagas disease-positive samples. The sensitivities of ARCHITECT Chagas, whole-cell lysate, TcF, TcBCDE, and CP1 + CP3 ELISA were respectively 100%, 100%, 98.9%, 98.9%, and 89.2% and the corresponding specificities were 100%, 99.1%, 99.1%, 100%, and 99.1%. False-positive results were obtained for whole-cell lysate, TcF, and CP1 ± CP3 ELISA. This is the first evidence that OD cut-off values optimized for in-house ELISA are similar in terms of sensitivity and specificity to those of the ARCHITECT Chagas test, supporting the use of these in-house assays as diagnostic tests for Chagas disease in the clinical setting in Japan. Copyright © 2020 Elsevier B.V. All rights reserved.

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