Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study.
Assessment of serological techniques for screening patients for COVID-19 (COVID-SER): a prospective, multicentric study.
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DOI：
10.1136/bmjopen-2020-041268
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发表时间：
2020-11-24
期刊：
影响因子：
2.9
通讯作者：
COVID-SER study group
中科院分区：
文献类型：
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作者：
Trouillet-Assant S;Albert Vega C;Bal A;Nazare JA;Fascia P;Paul A;Massardier-Pilonchery A;D Aubarede C;Guibert N;Pitiot V;Lahousse M;Boibieux A;Makhloufi D;Simon C;Rabilloud M;Trabaud MA;Gueyffier F;Fassier JB;COVID-SER study group
由SARS-CoV-2引起的COVID-19大流行威胁全球公共卫生，迫切需要评估对SARS-CoV-2的获得性免疫。血清学检测可能提供的结果可以补充或确认疑似COVID-19病例，并揭示既往感染。在一般人群中使用之前，必须对血清学检测试剂盒的性能（灵敏度和特异性）进行评价。还必须评价所产生抗体的中和能力。我们建立了一项前瞻性、多中心的临床研究，以评估血清学试剂盒在出现轻微症状提示SARS-CoV-2感染的医护人员人群中的性能。400名有症状的医护人员将被纳入COVID-SER研究。从大流行前纳入的对照队列中获得的数值将用作参考。建立了一个工作流程，以研究对SARS-CoV-2感染的血清学反应，并评估确诊SARS-CoV-2感染患者的抗体中和能力。将使用病毒的分子检测作为参考，评估检测的灵敏度和特异性。IgM和IgG抗体的测量将每周进行一次，连续6周，然后在诊断后6、12、18、24和36个月进行。IgM和IgG的动力学将决定进行血清学检测的最佳时期。将根据随后的血清转换确定有症状受试者中假阴性PCR检测的比例。已于2020年4月获得国家生物医学研究审查委员会（Comité de Protection des Personnes Sud Médiénée I，马赛，法国）的伦理批准（ID RCB 2020-A00932-37）。研究结果将通过在科学会议上的介绍和在同行评审的期刊上发表文章的方式传播。 NCT 04341142。
The COVID-19 pandemic caused by SARS-CoV-2 threatens global public health, and there is an urgent public health need to assess acquired immunity to SARS-CoV-2. Serological tests might provide results that can be complementary to or confirm suspected COVID-19 cases and reveal previous infection. The performance of serological assays (sensitivity and specificity) has to be evaluated before their use in the general population. The neutralisation capacity of the produced antibodies also has to be evaluated. We set up a prospective, multicentric clinical study to evaluate the performance of serological kits among a population of healthcare workers presenting mild symptoms suggestive of SARS-CoV-2 infection. Four hundred symptomatic healthcare workers will be included in the COVID-SER study. The values obtained from a control cohort included during the prepandemic time will be used as reference. A workflow was set up to study serological response to SARS-CoV-2 infection and to evaluate antibody neutralisation capacity in patients with a confirmed SARS-CoV-2 infection. The sensitivity and specificity of the tests will be assessed using molecular detection of the virus as a reference. The measurement of IgM and IgG antibodies will be performed once per week for 6 consecutive weeks and then at 6, 12, 18, 24 and 36 months after the diagnosis. The kinetics of IgM and IgG will determine the optimal period to perform serological testing. The proportion of false negative PCR tests in symptomatic subjects will be determined on the basis of subsequent seroconversions. Ethical approval has been obtained from the national review board for biomedical research in April 2020 (Comité de Protection des Personnes Sud Méditerranée I, Marseille, France) (ID RCB 2020-A00932-37). Results will be disseminated through presentations at scientific meetings and publications in peer-reviewed journals. NCT04341142.
影响因子：
82.9
作者：
Amanat F;Stadlbauer D;Strohmeier S;Nguyen THO;Chromikova V;McMahon M;Jiang K;Arunkumar GA;Jurczyszak D;Polanco J;Bermudez-Gonzalez M;Kleiner G;Aydillo T;Miorin L;Fierer DS;Lugo LA;Kojic EM;Stoever J;Liu STH;Cunningham-Rundles C;Felgner PL;Moran T;García-Sastre A;Caplivski D;Cheng AC;Kedzierska K;Vapalahti O;Hepojoki JM;Simon V;Krammer F
通讯作者：
Krammer F