Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
Servicio de Microbiología Clínica, Hospital Universitario Príncipe de Asturias, Madrid, Spain; Departamento de Biomedicina y Biotecnología, Facultad de Medicina, Universidad de Alcalá de Henares, Spain.
J Virol Methods. 2021 Mar;289:114047. doi: 10.1016/j.jviromet.2020.114047. Epub 2020 Dec 15.
Serologic techniques can serve as a complement to diagnose SARS-CoV-2 infection. The objective of our study was to compare the diagnostic performance of six immunoassays to detect antibodies against SARS-CoV-2: three lateral flow immunoassays (LFAs), one ELISA and two chemiluminescence assays (CLIAs).
We evaluated three LFAs (Alltest, One Step and SeroFlash), one ELISA (Dia.Pro) and two CLIAs (Elecsys and COV2T). To assess the specificity, 60 pre-pandemic sera were used. To evaluate the sensitivity, we used 80 serum samples from patients with positive PCR for SARS-CoV-2. Agreement between techniques was evaluated using the kappa score (k).
All immunoassays showed a specificity of 100 % except for SeroFlash (96.7 %). Overall sensitivity was 61.3 %, 73.8 %, 67.5 %, 85.9 %, 88.0 % and 92.0 % for Alltest, One Step, SeroFlash, Dia.Pro, Elecsys and COV2T, respectively. Sensitivity increased throughout the first two weeks from the onset of symptoms, reaching sensitivities over 85 % from 14 days for all LFAs, being One Step the most sensitive (97.6 %), followed by SeroFlash (95.1 %). Dia.Pro, Elecsys and COV2T showed sensitivities over 97 % from 14 days, being 100 % for COV2T. One Step showed the best agreement results among LFAs, showing excellent agreement with Dia.Pro (agreement = 94.2 %, k = 0.884), COV2T (99.1 %, k = 0.981) and Elecsys (97.3 %, k = 0.943). Dia.Pro, COV2T and Elecsys also showed excellent agreement between them.
One Step, Dia.Pro, Elecsys and COV2T obtained the best diagnostic performance results. All these techniques showed a specificity of 100 % and sensitivities over 97 % from 14 days after the onset of symptoms, as well as excellent levels of agreement.
血清学技术可作为诊断 SARS-CoV-2 感染的补充手段。本研究旨在比较六种免疫分析方法检测抗 SARS-CoV-2 抗体的诊断性能：三种侧向流动免疫分析（LFAs）、一种酶联免疫吸附测定（ELISA）和两种化学发光免疫分析（CLIAs）。
我们评估了三种 LFAs（Alltest、One Step 和 SeroFlash）、一种 ELISA（Dia.Pro）和两种 CLIAs（Elecsys 和 COV2T）。为了评估特异性，我们使用了 60 份大流行前血清。为了评估敏感性，我们使用了 80 份来自 SARS-CoV-2 PCR 阳性患者的血清样本。使用kappa 评分（k）评估技术之间的一致性。
除 SeroFlash（96.7%）外，所有免疫分析的特异性均为 100%。总体敏感性分别为 Alltest、One Step、SeroFlash、Dia.Pro、Elecsys 和 COV2T 的 61.3%、73.8%、67.5%、85.9%、88.0%和 92.0%。从症状出现的前两周开始，敏感性逐渐升高，所有 LFAs 的敏感性均超过 85%，从第 14 天开始，One Step 的敏感性最高（97.6%），其次是 SeroFlash（95.1%）。Dia.Pro、Elecsys 和 COV2T 从第 14 天开始敏感性超过 97%，COV2T 的敏感性为 100%。One Step 在 LFAs 中显示出最佳的一致性结果，与 Dia.Pro（一致性=94.2%，k=0.884）、COV2T（99.1%，k=0.981）和 Elecsys（97.3%，k=0.943）具有极好的一致性。Dia.Pro、COV2T 和 Elecsys 之间也显示出极好的一致性。
One Step、Dia.Pro、Elecsys 和 COV2T 获得了最佳的诊断性能结果。所有这些技术的特异性均为 100%，从症状出现后第 14 天开始敏感性超过 97%，并且具有极好的一致性水平。
