Mulder Leontine, Carrères Benoit, Muggli Franco, Zollinger Alix, Corthésy John, Klijn Adrianne, Togni Giuseppe
Clinical Laboratory, Medlon BV, P.O. Box 50000, 7500 KA Enschede, The Netherlands.
Clinical Chemistry, Ziekenhuis Groep Twente, P.O. Box 7600, 7600 SZ Almelo, The Netherlands.
J Clin Med. 2022 Apr 8;11(8):2100. doi: 10.3390/jcm11082100.
Since the SARS-CoV-2 pandemic, lateral flow assays (LFA) detecting specific antibodies have entered the market in abundance. Despite being CE-IVD-labeled, the antigenic compounds of the assays are often unknown, the performance characteristics provided by the manufacturer are often incomplete, and the samples used to obtain the data are not detailed.
To perform a comparative evaluation of nine lateral flow assays to detect IgG responses against SARS-CoV-2. For the evaluation, a carefully designed serum panel containing post-infection samples and post-vaccination (both mRNA vaccine and inactivated virus vaccine) samples was used.
The sensitivity of the assays overall ranged from 9 to 90.3% and the specificity ranged from 94.2 to 100%. Spike protein-containing assays performed generally better than the assays with only nucleocapsid protein. The sensitivity of some assays was higher on post-infection samples, while other assays had a higher sensitivity to post-vaccination samples.
A comparative approach in the verification of LFAs with an adequately designed serum panel enabled the identification of the antigens used in the assays. Sensitivities differed between post-infection and post-vaccination samples, depending on the assays used. This demonstrates that the verification of assays must be performed with samples representative of the intended use of the assay.
自新冠疫情以来，检测特定抗体的侧向流动分析（LFA）大量进入市场。尽管这些分析已获得CE-IVD认证，但其抗原成分往往不明，制造商提供的性能特征常常不完整，且用于获取数据的样本也未详细说明。
对九种检测针对新冠病毒IgG反应的侧向流动分析进行比较评估。评估时使用了精心设计的血清样本组，其中包含感染后样本以及接种疫苗后（包括mRNA疫苗和灭活病毒疫苗）的样本。
这些分析的总体灵敏度在9%至90.3%之间，特异性在94.2%至100%之间。含刺突蛋白的分析总体表现优于仅含核衣壳蛋白的分析。一些分析对感染后样本的灵敏度较高，而其他分析对接种疫苗后样本的灵敏度较高。
采用精心设计的血清样本组对侧向流动分析进行比较验证，能够识别分析中使用的抗原。感染后样本和接种疫苗后样本的灵敏度因所使用的分析方法而异。这表明必须使用代表分析预期用途的样本进行分析验证。
