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对中国杭州医护人员和患者进行的大规模新冠病毒分子和血清学筛查:在医院环境中未发现RNA检测证据、血清阳性率低且暴露风险有限。

Mass SARS-CoV-2 molecular and serological screening of medical staff and patients in Hangzhou, China: no evidence of RNA detection, low seroprevalence, and limited exposure risk in the hospital setting.

作者信息

Huang Jun, Zhang Lu, Wu Shengjun, Lu Jie, Li Fengying, Cheng Yulan, Zhang Qi, Li Guiling, Yu Haitao, Le Zhian, He Xiaowen, Ding Yanjun, Candotti Daniel, Xie Xinyou, Zhang Jun

机构信息

Department of Clinical Laboratory, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.

Key Laboratory of Biotherapy of Zhejiang Province, Hangzhou, China.

出版信息

Ann Transl Med. 2021 Apr;9(7):552. doi: 10.21037/atm-20-7163.

Abstract

BACKGROUND

To assess and limit the SARS-CoV-2 exposure risk from symptomless individuals in the hospital setting, molecular and serological screening of staff and patients attending a tertiary hospital in China was conducted.

METHODS

SARS-CoV-2 RNA was tested by quantitative RT-PCR. Anti-SARS-CoV-2 IgM and IgG were screened initially with two lateral flow immunoassays (LFIs) and further confirmed with three chemiluminescence immunoassays (CLIAs). The assay performance was assessed using archived samples from 32 confirmed COVID-19 cases and 80 healthy individuals.

RESULTS

Between April 24 and May 8, 2020, 16,043 subjects (7,392 medical staff, 4,714 inpatients, 1,209 chaperones, 1,705 outpatients, and 1,023 fever clinic patients) were screened. No subject tested positive for viral RNA. Seventy-three (0.46%) tested positive for IgM or IgG on the initial LFI screening, of whom 63 were investigated with CLIAs: 2 (0.01%) were confirmed as seroreactive and 18 (0.11%) were indeterminate. Unconfirmed seroreactivity was significantly more frequent in fever clinic patients. The CLIAs showed similar (95.0-100%) IgM or IgG specificity but higher IgG sensitivity (93.75-96.88% . 31.25-81.25%) than the LFIs. The confirmed seropositive cases included a previously discharged COVID-19 patient and an undiagnosed symptomless patient showing detectable IgM and IgG over 35 days of follow-up. No transmission was evidenced within the corresponding family cluster.

CONCLUSIONS

Low SARS-CoV-2 prevalence and limited exposure risk were observed. Seroprevalence varied between 0.012% and 0.12% according to the testing algorithm and the confirmation criteria used, indicating that quality standards for serological tests are needed. Protective immunity in asymptomatic COVID-19 patients who recovered needs to be investigated further, but the associated risk of transmission appeared limited.

摘要

背景

为评估并限制医院环境中无症状个体感染严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的风险,对中国一家三级医院的工作人员和患者进行了分子和血清学筛查。

方法

采用定量逆转录聚合酶链反应(RT-PCR)检测SARS-CoV-2 RNA。最初使用两种侧向流动免疫分析法(LFI)筛查抗SARS-CoV-2 IgM和IgG,并进一步用三种化学发光免疫分析法(CLIA)进行确认。使用来自32例确诊新型冠状病毒肺炎(COVID-19)病例和80名健康个体的存档样本评估检测性能。

结果

在2020年4月24日至5月8日期间,对16043名受试者(7392名医务人员、4714名住院患者、1209名陪护人员、1705名门诊患者和1023名发热门诊患者)进行了筛查。没有受试者的病毒RNA检测呈阳性。73名(0.46%)受试者在初次LFI筛查中IgM或IgG检测呈阳性,其中63名接受了CLIA检测:2名(0.01%)被确认为血清反应阳性,18名(0.11%)结果不确定。未确诊的血清反应阳性在发热门诊患者中更为常见。CLIA显示出相似的(95.0 - 100%)IgM或IgG特异性,但IgG敏感性高于LFI(93.75 - 96.88% 对31.25 - 81.25%)。确诊的血清阳性病例包括一名先前出院的COVID-19患者和一名未确诊的无症状患者,该无症状患者在35天的随访中IgM和IgG均可检测到。在相应的家庭聚集性病例中未发现传播证据。

结论

观察到SARS-CoV-2感染率较低且暴露风险有限。根据所使用的检测算法和确认标准,血清阳性率在0.012%至0.12%之间,这表明需要血清学检测的质量标准。康复的无症状COVID-19患者的保护性免疫需要进一步研究,但相关的传播风险似乎有限。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d346/8105841/47a2aea08bf9/atm-09-07-552-f1.jpg

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