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Abstract
Background
Rotavirus is a major pathogen causing enteritis worldwide in children under five years of age. In recent years, immunochromato-graphic assay (ICA) has been widely used as a diagnostic test for rotavirus detection. This study aimed to compare and evaluate the performance of ICA-based rotavirus rapid test kits from two manufacturers.
Methods
Residual stool samples from a total of 130 children with acute enterocolitis from November 2017 to January 2018 were used. We compared the results of the two immunochromatographic methods (SD BIOLINE Rotavirus kit and GENEDIA Rotavirus Ag Rapid Test) with those of the currently used enzyme immunoassay method.
Results
Positive agreement, negative agreement, and total agreement rates between the SD BIOLINE rotavirus kit and the enzyme immunoassay were 98.0%, 100%, and 99.2%, respectively. Positive agreement, negative agreement, and total agreement rates between the GENEDIA Rotavirus Ag Rapid Test and the enzyme immunoassay were 96.0%, 100%, and 98.4%, respectively.
References
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Table 1.
Comparison of rotavirus detection results of SD BIOLINE Rotavirus kit and GENEDIA Rotavirus Ag Rapid Test with those obtained by ELISA
| ELISA | ||||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| ICA (SD) | Positive | 49 | 0 | 49 |
| Negative | 1 | 80 | 81 | |
| Total | 50 | 80 | ||
| ICA (GENEDIA) | Positive | 48 | 0 | 48 |
| Negative | 2 | 80 | 82 | |
| Total | 50 | 80 | ||
SD, Positive agreement rate: 98.0% (95% confidence interval: 89.4–99.9%); negative agreement rate: 100% (95% confidence interval: 95.5–100.0%); total agreement rate: 99.2% (95% confidence interval: 95.8–99.9%); Kappa coefficient=0.984 (95% confidence interval: 0.953–1.015).
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