Ann Lab Med.  2019 Jan;39(1):50-57. 10.3343/alm.2019.39.1.50.

Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples

• Kim JS
• Lee SK
• Ko DH
• Hyun J
• Kim HS

• KMID: 2420271
• DOI: http://doi.org/10.3343/alm.2019.39.1.50

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.

Keyword

Rotavirus; AFIAS rotavirus assay; Immunoassay; Performance; Genotype

MeSH Terms

Enzyme-Linked Immunosorbent Assay
Gangwon-do
Genotype
Immunoassay*
Immunochromatography
Korea
Limit of Detection
Polymerase Chain Reaction
Rotavirus Infections
Rotavirus*
Sensitivity and Specificity

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