临床样本中轮状病毒检测的自动化荧光免疫分析系统性能评估。
Performance Evaluation of the Automated Fluorescent Immunoassay System Rotavirus Assay in Clinical Samples.
机构信息
Department of Laboratory Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.
出版信息
Ann Lab Med. 2019 Jan;39(1):50-57. doi: 10.3343/alm.2019.39.1.50.
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.
背景
自动荧光免疫分析系统（AFIAS）轮状病毒检测（Boditech Med Inc.，韩国春川）是一种用于检测轮状病毒的新型快速抗原检测方法。我们评估了该检测方法在检测临床粪便样本中的轮状病毒及其特定基因型方面的性能。
方法
在 103 份轮状病毒阳性和 103 份轮状病毒阴性粪便样本（通过 PCR 和 ELISA 均确认）中进行 AFIAS 轮状病毒检测，并将其结果与 PCR、ELISA 和免疫层析检测（ICA）进行比较。我们评估了 AFIAS 轮状病毒检测的诊断灵敏度/特异性、轮状病毒亚型的检测能力、最低检测限（LLOD）、重复性、交叉反应性和干扰性。
结果
基于 PCR 和 ELISA 结果，AFIAS 轮状病毒检测的诊断灵敏度和特异性均为 99.0%。LLO 结果表明，AFIAS 检测法的灵敏度与 ICA 和 ELISA 相似或更高。高重复性得到了确认，并且没有检测到交叉反应或干扰。该检测法可以检测到基因型 G1P[8]、G2P[4]、G3P[8]、G4P[6]、G4P[8]、G8P[4]、G8P[8]、G9P[4]和 G9P[8]。
结论
AFIAS 轮状病毒检测法具有高重复性、灵敏度和特异性，并且与 ELISA、PCR 和 ICA 具有良好的一致性。它可以检测到韩国流行的最常见和不常见的轮状病毒基因型。它可以作为一种有用的现场检测方法，用于快速、方便且具有成本效益的检测轮状病毒感染。
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