商业侧向流动免疫分析与 ELISA 用于 SARS-CoV-2 抗体检测的比较。
Comparison of commercial lateral flow immunoassays and ELISA for SARS-CoV-2 antibody detection.
机构信息
Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.
Microbiology Department, Consorcio Hospital General Universitario. Address: Av. Tres Cruces s/n, 46014, Valencia, Spain.
出版信息
J Clin Virol. 2020 Aug;129:104529. doi: 10.1016/j.jcv.2020.104529. Epub 2020 Jun 29.
BACKGROUND
COVID-19 pandemic has spread worldwide since December 2019. Serological tests for SARS-CoV-2 antibody testing are needed for detection of current or past infections. A wide range of commercial tests is available. However, most of them need to be validated.
STUDY DESIGN
The aim was to compare a commercial IgG and IgA ELISA (Euroimmun) with three lateral flow immunoassays (LFI): Hangzhou Alltest Biotech, Wuhan UNscience Biotechnology and Guangzhou Wondfo Biotech. Specificity was calculated with 62 available serum samples from 2018/19. The study included 152 sera from patients of which 109 were RT-PCR positive. Sensitivities for ELISA anti SARS-CoV-2 IgG and IgA were 81.5 % and 93.1 % and specificities 100 % and 80.6 %, respectively. LFI showed variable performances, overall results being better for Guangzhou Wondfo Biotech.
CONCLUSIONS
Commercial serological tests are useful for detection of antibodies in patients with COVID-19. ELISA presented better results than LFI. The results allowed to incorporate the most sensitive LFI to the daily workflow, combining with ELISA. Careful validation is encouraged before clinical laboratories start using these tests.
背景
自 2019 年 12 月以来，COVID-19 疫情已在全球范围内蔓延。需要进行 SARS-CoV-2 抗体检测的血清学检测来检测当前或过去的感染。有各种各样的商业检测方法，但大多数都需要验证。
设计
本研究旨在比较一种商业 IgG 和 IgA ELISA（欧蒙）与三种侧向流动免疫测定法（LFI）：杭州艾康生物技术、武汉华大因源生物技术和广州万孚生物技术。特异性用 2018/19 年的 62 个血清样本计算。该研究纳入了 152 例患者的血清，其中 109 例 RT-PCR 阳性。ELISA 抗 SARS-CoV-2 IgG 和 IgA 的灵敏度分别为 81.5%和 93.1%，特异性分别为 100%和 80.6%。LFI 表现出不同的性能，整体结果以广州万孚生物技术更好。
结论
商业血清学检测可用于检测 COVID-19 患者的抗体。ELISA 比 LFI 结果更好。这些结果允许将最敏感的 LFI 与 ELISA 结合，纳入日常工作流程。在临床实验室开始使用这些检测方法之前，鼓励进行仔细验证。
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