Objectives

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).

Methods

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).

Results

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.

Conclusions

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.

中文翻译：

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六种免疫分析检测抗SARS-CoV-2抗体的比较评估

目标

血清学技术可以作为诊断SARS-CoV-2感染的补充。我们研究的目的是比较六种免疫分析检测抗SARS-CoV-2抗体的诊断性能：三种侧向免疫分析（LFA），一种ELISA和两种化学发光分析（CLIA）。

方法

我们评估了3个LFAs（Alltest，一步一个脚印和SeroFlash），一个ELISA（直径。临）和两个CLIAs（Elecsys测定和COV2T）。为了评估特异性，使用了60种大流行前血清。为了评估敏感性，我们使用了来自阳性PCR患者SARS-CoV-2的80个血清样本。使用卡伯分数（k）评估技术之间的一致性。

结果

除SeroFlash（96.7％）外，所有免疫测定均显示100％的特异性。Alltest，One Step，SeroFlash，Dia.Pro，Elecsys和COV2T的总体灵敏度分别为61.3％，73.8％，67.5％，85.9％，88.0％和92.0％。从症状发作开始的前两周，敏感性提高，所有LFA从14天起的敏感性均达到85％以上，其中一步最敏感（97.6％），其次是SeroFlash（95.1％）。Dia.Pro，Elecsys和COV2T从14天开始显示超过97％的敏感性，对于COV2T。一步展示了LFA中最好的一致性结果，显示出与Dia.Pro（一致性= 94.2％，k  = 0.884），COV2T（99.1％，k  = 0.981）和Elecsys（97.3％，k  = 0.943）的一致性很好。Dia.Pro，COV2T和Elecsys也表现出了极好的一致性。

结论

一步，Dia.Pro，Elecsys和COV2T获得了最佳的诊断性能结果。所有这些技术从出现症状后的14天起显示出100％的特异性和97％以上的敏感性，以及极好的一致性。