Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection spreaded rapidly worldwide, as far as it has become a global pandemic. Therefore, the introduction of serological tests for determination of IgM and IgG antibodies has become the main diagnostic tool, useful for tracking the spread of the virus and for consequently allowing its containment. In our study we compared point of care test (POCT) lateral flow immunoassay (FIA) vs automated chemiluminescent immunoassay (CLIA), in order to assess their specificity and sensibility for COVID-19 antibodies detection. We find that different specificities and sensitivities for IgM and IgG tests. Notably IgM POCT FIA method vs CLIA method (gold standard) has a low sensitivity (0.526), while IgG POCT FIA method vs CLIA method (gold standard) test has a much higher sensitivity (0.937); further, with respect of IgG, FIA and CLIA could arguably provide equivalent information. FIA method could be helpful in assessing in short time, the possible contagiousness of subjects that for work reasons cannot guarantee “social distancing”.

中文翻译：

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COVID-19 的血清学决定因素

严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染在全球范围内迅速传播，已成为全球大流行。因此，引入血清学检测来测定 IgM 和 IgG 抗体已成为主要的诊断工具，可用于跟踪病毒的传播并从而控制病毒。在我们的研究中，我们比较了床旁检测 (POCT) 侧流免疫分析 (FIA) 与自动化学发光免疫分析 (CLIA)，以评估它们对 COVID-19 抗体检测的特异性和敏感性。我们发现 IgM 和 IgG 测试的特异性和敏感性不同。值得注意的是，IgM POCT FIA 方法与 CLIA 方法（金标准）的灵敏度较低（0.526），而 IgG POCT FIA 方法与 CLIA 方法（金标准）测试的灵敏度要高得多（0.937）；此外，对于 IgG，FIA 和 CLIA 可以说可以提供同等信息。FIA方法可能有助于在短时间内评估因工作原因无法保证“社交距离”的受试者可能的传染性。