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

被引:8
|
作者
Kim, Jae-Seok [1 ]
Lee, Su-Kyung [2 ]
Ko, Dae-Hyun [2 ]
Hyun, Jungwon [2 ]
Kim, Hyun Soo [2 ]
机构
[1] Hallym Univ, Coll Med, Kangdong Sacred Heart Hosp, Dept Lab Med, Seoul, South Korea
[2] Hallym Univ, Coll Med, Dongtan Sacred Heart Hosp, Dept Lab Med, 7 Keunjaebong Gil, Hwaseong 18450, South Korea
基金
新加坡国家研究基金会;
关键词
Rotavirus; AFIAS rotavirus assay; Immunoassay; Performance; Genotype; STOOL SPECIMENS; ANTIGEN; GASTROENTERITIS; GENOTYPE; CHILDREN; KITS;
D O I
10.3343/alm.2019.39.1.50
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
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.
引用
收藏
页码:50 / 57
页数:8
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