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两种快速侧向流动免疫层析检测法预测血清中 SARS-CoV-2 中和活性的适用性。

Suitability of two rapid lateral flow immunochromatographic assays for predicting SARS-CoV-2 neutralizing activity of sera.

机构信息

Microbiology Service, Hospital Clínico Universitario, INCLIVA Health Research Institute, Valencia, Spain.

Institute for Integrative Systems Biology (I2SysBio), Universitat de Valencia-CSIC, Valencia, Spain.

出版信息

J Med Virol. 2021 Apr;93(4):2301-2306. doi: 10.1002/jmv.26697. Epub 2020 Dec 17.

Abstract

Assessment of commercial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassays for their capacity to provide reliable information on sera neutralizing activity is an emerging need. We evaluated the performance of two commercially available lateral flow immunochromatographic assays (LFIC; Wondfo SARS-CoV-2 Antibody test and the INNOVITA 2019-nCoV Ab test) in comparison with a SARS-CoV-2 neutralization pseudotyped assay for coronavirus disease 2019 (COVID-19) diagnosis in hospitalized patients and investigate whether the intensity of the test band in LFIC associates with neutralizing antibody (NtAb) titers. Ninety sera were included from 51 patients with moderate to severe COVID-19. A green fluorescent protein (GFP) reporter-based pseudotyped neutralization assay (vesicular stomatitis virus coated with SARS-CoV-2 spike protein) was used. Test line intensity was scored using a 4-level scale (0 to 3+). The overall sensitivity of LFIC assays was 91.1% for the Wondfo SARS-CoV-2 Antibody test, 72.2% for the INNOVITA 2019-nCoV IgG, 85.6% for the INNOVITA 2019-nCoV IgM, and 92.2% for the NtAb assay. Sensitivity increased for all assays in sera collected beyond day 14 after symptoms onset (93.9%, 79.6%, 93.9%, and 93.9%, respectively). Reactivities equal to or more intense than the positive control line (≥2+) in the Wondfo assay had a negative predictive value of 100% and a positive predictive value of 96.4% for high NtAb titers (≥1/160). Our findings support the use of LFIC assays evaluated herein, particularly the Wondfo test, for COVID-19 diagnosis. We also find evidence that these rapid immunoassays can be used to predict high SARS-CoV-2-S NtAb titers.

摘要

评估商业严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)免疫测定法在提供血清中和活性可靠信息方面的能力是当前的需求。我们评估了两种市售侧向流动免疫层析测定法(LFIC;万孚 SARS-CoV-2 抗体检测和 INNOVITA 2019-nCoV Ab 检测)与用于诊断 2019 年冠状病毒病(COVID-19)的 SARS-CoV-2 中和假型测定法的性能,并研究 LFIC 检测带的强度是否与中和抗体(NtAb)滴度相关。共纳入 51 例中重度 COVID-19 住院患者的 90 份血清。采用基于绿色荧光蛋白(GFP)报告基因的假型中和测定法(用 SARS-CoV-2 刺突蛋白包裹的水疱性口炎病毒)。使用 4 级评分(0 至 3+)对检测线强度进行评分。Wondfo SARS-CoV-2 抗体检测的 LFIC 测定法的总体敏感性为 91.1%,INNOVITA 2019-nCoV IgG 为 72.2%,INNOVITA 2019-nCoV IgM 为 85.6%,NtAb 测定法为 92.2%。在症状出现后第 14 天及以后采集的血清中,所有检测的敏感性均增加(分别为 93.9%、79.6%、93.9%和 93.9%)。在 Wondfo 检测中,与阳性对照线等强度或更强烈(≥2+)的反应的阴性预测值为 100%,对高 NtAb 滴度(≥1/160)的阳性预测值为 96.4%。我们的研究结果支持使用本文评估的 LFIC 检测法,特别是 Wondfo 检测法,用于 COVID-19 诊断。我们还发现证据表明,这些快速免疫测定法可用于预测高 SARS-CoV-2-S NtAb 滴度。

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