Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Department of Transfusion Medicine and Haematology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Blood Transfus. 2021 May;19(3):181-189. doi: 10.2450/2021.0324-20. Epub 2021 Feb 3.
The Milan metropolitan area in Northern Italy was among the most severely hit by the SARS-CoV-2 outbreak. The aim of this study was to examine the seroprevalence trends of SARS-CoV-2 in healthy asymptomatic adults, and the risk factors and laboratory correlates of positive tests.
We conducted a cross-sectional study in a random sample of blood donors, who were asymptomatic at the time of evaluation, at the beginning of the first phase (February 24 to April 8 2020; n=789). Presence of IgM/IgG antibodies against the SARS-CoV-2-Nucleocapsid protein was assessed by a lateral flow immunoassay.
The test had a 100/98.3 sensitivity/specificity (n=32/120 positive/negative controls, respectively), and the IgG test was validated in a subset by an independent ELISA against the Spike protein (n=34, p<0.001). At the start of the outbreak, the overall adjusted seroprevalence of SARS-CoV-2 was 2.7% (95% CI: 0.3-6%; p<0.0001 vs 120 historical controls). During the study period, characterised by a gradual implementation of social distancing measures, there was a progressive increase in the adjusted seroprevalence to 5.2% (95% CI: 2.4-9.0; 4.5%, 95% CI: 0.9-9.2% according to a Bayesian estimate) due to a rise in IgG reactivity to 5% (95% CI: 2.8-8.2; p=0.004 for trend), but there was no increase in IgM (p=not significant). At multivariate logistic regression analysis, IgG reactivity was more frequent in younger individuals (p=0.043), while IgM reactivity was more frequent in individuals aged >45 years (p=0.002).
SARS-CoV-2 infection was already circulating in Milan at the start of the outbreak. The pattern of IgM/IgG reactivity was influenced by age: IgM was more frequently detected in participants aged >45 years. By the end of April, 2.4-9.0% of healthy adults had evidence of seroconversion.
意大利北部的米兰大都市区是受 SARS-CoV-2 爆发影响最严重的地区之一。本研究的目的是检测健康无症状成年人中 SARS-CoV-2 的血清流行趋势,以及阳性检测的风险因素和实验室相关性。
我们在评估时无症状的献血者随机样本中进行了一项横断面研究,该研究于 2020 年 2 月 24 日至 4 月 8 日第一阶段进行(n=789)。使用侧向流动免疫测定法检测针对 SARS-CoV-2-核衣壳蛋白的 IgM/IgG 抗体的存在。
该测试的灵敏度/特异性为 100/98.3(n=32/120 阳性/阴性对照,分别),并且 IgG 测试在一个子集中通过针对 Spike 蛋白的独立 ELISA 进行了验证(n=34,p<0.001)。在疫情爆发初期,SARS-CoV-2 的总体调整血清流行率为 2.7%(95%CI:0.3-6%;p<0.0001 与 120 个历史对照)。在此期间,随着社交距离措施的逐步实施,调整后的血清流行率逐渐增加至 5.2%(95%CI:2.4-9.0;4.5%,95%CI:0.9-9.2%,根据贝叶斯估计),这是由于 IgG 反应性上升至 5%(95%CI:2.8-8.2;p=0.004 趋势),但 IgM 没有增加(p=不显著)。在多变量逻辑回归分析中,IgG 反应性在年轻个体中更为常见(p=0.043),而 IgM 反应性在年龄>45 岁的个体中更为常见(p=0.002)。
SARS-CoV-2 感染在疫情爆发初期已在米兰流行。IgM/IgG 反应性的模式受年龄影响:IgM 在年龄>45 岁的参与者中更为常见。到 4 月底,有 2.4-9.0%的健康成年人有血清转化的证据。