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Optimization and evaluation of the ARCHITECT Chagas assay and in-house ELISA for Chagas disease in clinical settings in Japan
- Source :
- Parasitology international. 80
- Publication Year :
- 2020
-
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.
- Subjects :
- 0301 basic medicine
Chagas disease
Diagnostic methods
Trypanosoma cruzi
030231 tropical medicine
Clinical settings
Enzyme-Linked Immunosorbent Assay
Sensitivity and Specificity
03 medical and health sciences
0302 clinical medicine
Japan
parasitic diseases
Medicine
Humans
Chagas Disease
biology
business.industry
Diagnostic Tests, Routine
Diagnostic test
030108 mycology & parasitology
biology.organism_classification
medicine.disease
Serum samples
Virology
Infectious Diseases
Parasitology
business
Subjects
Details
- ISSN :
- 18730329
- Volume :
- 80
- Database :
- OpenAIRE
- Journal :
- Parasitology international
- Accession number :
- edsair.doi.dedup.....2e39e337aaecfcf8c7a40cd6cb41821f