Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples.
AFIAS rotavirus assay
Genotype
Immunoassay
Performance
Rotavirus
Journal
Annals of laboratory medicine
ISSN: 2234-3814
Titre abrégé: Ann Lab Med
Pays: Korea (South)
ID NLM: 101571172
Informations de publication
Date de publication:
Jan 2019
Jan 2019
Historique:
received:
22
11
2017
revised:
05
04
2018
accepted:
16
08
2018
entrez:
15
9
2018
pubmed:
15
9
2018
medline:
24
11
2018
Statut:
ppublish
Résumé
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. 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. 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]. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 30215230
pii: 39.50
doi: 10.3343/alm.2019.39.1.50
pmc: PMC6143470
doi:
Substances chimiques
Antigens, Viral
0
Reagent Kits, Diagnostic
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
50-57Subventions
Organisme : Ministry of Trade, Industry and Energy
ID : 10047748
Organisme : National Research Foundation of Korea
ID : NRF-2017R1D1A3 B03031940
Informations de copyright
© The Korean Society for Laboratory Medicine.
Déclaration de conflit d'intérêts
No potential conflicts of interest relevant to this article were reported.
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