Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples
Annals of Laboratory Medicine
; : 50-57, 2019.
Article
em En
| WPRIM
| ID: wpr-719648
Biblioteca responsável:
WPRO
ABSTRACT
BACKGROUND: The Automated Fluorescent Immunoassay System (AFIAS) rotavirus assay (Boditech Med Inc., Chuncheon, Korea) is a new rapid antigen test for rotavirus detection. We evaluated the performance of this assay for detecting rotaviruses and their specific genotypes in clinical stool samples. METHODS: AFIAS rotavirus assay was performed in 103 rotavirus-positive and 103 rotavirus-negative stool samples (confirmed by both PCR and ELISA), and its results were compared with those of PCR, ELISA, and immunochromatographic assay (ICA). We evaluated diagnostic sensitivity/specificity, the detectability of rotavirus subtypes, lower limit of detection (LLOD), reproducibility, cross-reactivity, and interference of AFIAS rotavirus assay. RESULTS: Based on PCR and ELISA results, diagnostic sensitivity and specificity of the AFIAS rotavirus assay were both 99.0%. LLOD results showed that the AFIAS assay had sensitivity similar to or greater than ICA and ELISA. High reproducibility was confirmed, and no cross-reactivity or interference was detected. This assay could detect genotypes G1P[8], G2P[4], G3P[8], G4P[6], G4P[8], G8P[4], G8P[8], G9P[4], and G9P[8]. CONCLUSIONS: The AFIAS rotavirus assay showed high reproducibility, sensitivity, and specificity as well as excellent agreement with ELISA, PCR, and ICA. It detected the most common as well as unusual genotypes of rotavirus prevalent in Korea. It could be a useful on-site assay for rapid, convenient, and cost-effective detection of rotavirus infection.
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Texto completo:
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Base de dados:
WPRIM
Assunto principal:
Infecções por Rotavirus
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Ensaio de Imunoadsorção Enzimática
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Imunoensaio
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Reação em Cadeia da Polimerase
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Cromatografia de Afinidade
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Sensibilidade e Especificidade
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Rotavirus
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Limite de Detecção
/
Genótipo
/
Coreia (Geográfico)
Tipo de estudo:
Diagnostic_studies
País/Região como assunto:
Asia
Idioma:
En
Revista:
Annals of Laboratory Medicine
Ano de publicação:
2019
Tipo de documento:
Article