Evaluation of the SD Bioline Norovirus rapid immunochromatography test using fecal specimens from Korean gastroenteritis patients.
Evaluation of the SD Bioline Norovirus rapid immunochromatography test using fecal specimens from Korean gastroenteritis patients.
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DOI：
10.1016/j.jviromet.2012.08.014
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发表时间：
2012-12
影响因子：
3.1
通讯作者：
Lee KM
中科院分区：
文献类型：
--
作者：
Kim HS;Hyun J;Kim JS;Song W;Kang HJ;Lee KM
► 对诺如病毒的新免疫层析测试进行了评估。 ► 该测试显示出卓越的重现性，无交叉反应且无干扰。 ► 与实时PCR相比，该测试显示出较高的一致性。 ► 该检测是快速筛查诺如病毒感染的有用工具。评估了新型快速免疫层析测试 SD Bioline 诺如病毒测试的分析和临床性能，用于检测粪便样本中的人类诺如病毒。对检测限、重现性、交叉反应性和干扰进行了分析性能研究。为了进行比较，使用了 92 份诺如病毒阳性粪便样本和 126 份诺如病毒阴性样本，并通过 2 种不同的实时 PCR 试剂盒确认了结果。快速免疫层析测试在粪便样本中检测到相当于 4.48 × 106 拷贝/mL 的诺如病毒基因组。在进行重复性/再现性测试时，高于此浓度的样品均提供阳性结果 (100%)，97.8% 略低于此浓度的样品 (2.45 × 106 拷贝/mL) 提供阴性结果。未检测到交叉反应或干扰。与实时 PCR 检测相比，快速免疫层析检测的阳性一致性百分比（敏感性）、阴性一致性百分比（特异性）和总体一致性百分比分别为 90.2%、100% 和 95.9%。此外，快速免疫层析测试在20分钟内完成。因此，与实时 PCR 相比，SD Bioline 诺如病毒检测更容易、更快速，并且表现出优异的重现性、无交叉反应性、无干扰且一致性高。因此，该测试可用于快速筛查以识别诺如病毒感染。
► The new immunochromatography test for norovirus was evaluated. ► This test showed excellence reproducibility, no cross-reactivity and no interference. ► This test showed high agreement rate compared with real-time PCR. ► The assay is a useful tool for rapid screening to identify of norovirus infection. The analytical and clinical performance of a new rapid immunochromatography test, the SD Bioline Norovirus test, was evaluated for the detection of human norovirus in fecal specimens. The analytical performance studies were performed for detection limit, reproducibility, cross-reactivity, and interference. For comparison, 92 norovirus-positive stool samples and 126 norovirus-negative samples for which the results were confirmed by 2 different real-time PCR kits were used. The rapid immunochromatography test detected the equivalent of 4.48 × 106 copies/mL of the norovirus genome in stool samples. On performing the repeatability/reproducibility test, samples above this concentration all provided positive results (100%) and 97.8% of the samples slightly below this concentration (2.45 × 106 copies/mL) provided negative results. No cross-reactivity or interference was detected. Positive percent agreement (sensitivity), negative percent agreement (specificity), and overall percent agreement of the rapid immunochromatography test compared with testing by real-time PCR were 90.2%, 100%, and 95.9%, respectively. In addition, the rapid immunochromatography test was completed within 20 min. The SD Bioline Norovirus test was, therefore, easier and more rapid to perform and showed excellent reproducibility, no cross-reactivity, no interference, and high agreement compared with real-time PCR. Thus, this test is useful for rapid screening to identity norovirus infection.
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影响因子：
4.9
作者：
Park KS;Baek KA;Kim DU;Kwon KS;Bing SH;Park JS;Nam HS;Lee SH;Choi YJ
通讯作者：
Choi YJ
影响因子：
8.8
作者：
Kirby, Andrew;Gurgel, Ricardo Q.;Cuevas, Luis E.
通讯作者：
Cuevas, Luis E.
影响因子：
12.7
作者：
Chung, Ju-Young;Han, Tae-Hee;Hwang, Eung-Soo
通讯作者：
Hwang, Eung-Soo
DOI：
10.1016/j.diagmicrobio.2011.08.023
发表时间：
2011-12-01
影响因子：
2.9
作者：
Monteiro Siqueira, Jones Anderson;Linhares, Alexandre da Costa;Gabbay, Yvone Benchimol
通讯作者：
Gabbay, Yvone Benchimol
影响因子：
3.1
作者：
de Bruin, Erwin;Duizer, Erwin;Koopmans, Marion P. G.
通讯作者：
Koopmans, Marion P. G.