An evaluation of a rapid portable gold-nanotechnology measuring SARS-CoV-2 IgM, IgA and IgG antibody concentrations against spike 1 (S1), spike 2 (S) and nucleocapsid (N) was conducted using serum samples from 74 patients tested for SARS-CoV-2 RNA on admission to hospital, and 47 historical control patients from March 2019. 59 patients were RNA(+) and 15 were RNA(−). A serum (±) classification was derived for all three antigens and a quantitative serological profile was obtained. Serum(+) was identified in 30% (95% CI 11–48) of initially RNA(−) patients, in 36% (95% CI 17–54) of RNA(+) patients before 10 days, 77% (95% CI 67–87) between 10 and 20 days and 95% (95% CI 86–100) after 21 days. The patient-level diagnostic accuracy relative to RNA(±) after 10 days displayed 88% sensitivity (95% CI 75–95) and 75% specificity (95% CI 22–99), although specificity compared with historical controls was 100% (95%CI 91–100). This study provides robust support for further evaluation and validation of this novel technology in a clinical setting and highlights challenges inherent in assessment of serological tests for an emerging disease such as COVID-19.

中文翻译：

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一种新型技术的实时评估，该技术可对同时出现COVID-19综合征的患者群中的多种SARS-CoV-2抗原同时进行定量抗体检测。

使用来自74名接受SARS检验的患者的血清样本进行了快速便携式金纳米技术评估，该技术可测量SARS-CoV-2 IgM，IgA和IgG对刺1（S1），刺2（S）和核衣壳（N）的抗体浓度。 -CoV-2 RNA自2019年3月起入院，并有47名历史对照患者.59名患者为RNA（+），15名患者为RNA（-）。获得所有三种抗原的血清（±）分类，并获得定量的血清学特征。在最初的RNA（-）患者中，有30％（95％CI 11-48）患者中发现了血清（+），在10天之前，在RNA（+）患者中有36％（95％CI 17-54）中发现了血清，（77％（95在10到20天之间的百分比CI 67–87）和21天后95％（95％CI 86-100）。10天后相对于RNA（±）的患者水平的诊断准确性显示出88％的敏感性（95％CI 75–95）和75％的特异性（95％CI 22–99），尽管与历史对照相比特异性为100％（95％CI 91-100）。这项研究为在临床环境中进一步评估和验证该新技术提供了有力的支持，并突出了评估新兴疾病（例如COVID-19）的血清学检测所固有的挑战。