文章基本信息

标题：Clinical evaluation of rapid fluorescent diagnostic immunochromatographic test for influenza A virus (H1N1)
本地全文：下载
作者：Seung-Taek Yu ; Cuc Thi Bui ; Do Thi Hoang Kim 等
期刊名称：Scientific Reports
电子版ISSN：2045-2322
出版年度：2018
卷号：8
期号：1
页码：13468
DOI：10.1038/s41598-018-31786-8
语种：English
出版社：Springer Nature
摘要：Rapid diagnostic tests (RDTs) have been developed to detect influenza A virus for the swift diagnosis and management of patients. However, despite the simplicity and convenience, the low sensitivity of RDTs remains a limitation for their use in point of care testing (POCT). In this study, we developed a rapid fluorescent immunochromatographic strip test (FICT) and the performance of FICT was confirmed by the real-time reverse transcription-polymerase chain reaction (rRT-PCR) of H1N1, compared with that of RDT. The limit of detection (LOD) of FICT was improved by 16-fold compared to RDT. FICT showed 85.29% sensitivity (29/34) (95% Confidence Interval [95% CI]: 68.94 to 95.05), 100% specificity (26/26) (95% CI: 86.78 to 100.00), and a strong correlation (kappa; 0. 92) compared with rRT-PCR (20 ≤ Ct ≤ 36). In contrast, RDT (Standard Diagnostics [SD] BIOLINE Influenza Ag A/ B/ A(H1N1) Pandemic) showed 55.88% sensitivity (19/34) (95% CI: 37.87 to 72.82), 100% specificity (26/26) (95% CI: 77.07 to 100), and had a fair correlation with rRT-PCR (kappa; 0. 75). FICT had better sensitivity than RDT ( P < 0.01; McNemar’s test). Therefore, FICT has the potential to improve the quality of current rapid POCT for the diagnosis of influenza A/H1N1 infection.