The complexities of SARS-CoV-2 serology.
The complexities of SARS-CoV-2 serology.
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DOI：
10.1016/s1473-3099(20)30699-x
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Beale R
中科院分区：
文献类型：
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作者：
Houlihan CF;Beale R
诊断既往呼吸道病毒感染具有挑战性。我们对严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）的个体和人群水平免疫力的了解仍然不完整，开发可靠的血清学检测方法来检测既往感染一直是全球科学工作的重点。对于公共卫生规划，我们需要对来自已证实季节性（非严重急性呼吸系统综合征）冠状病毒的个体以及具有良好特征的症状和无症状确诊SARS-CoV-2感染的个体的大型样本库进行验证的可扩展检测。由于与季节性冠状病毒的交叉反应性而导致的假阳性结果是必须避免的，特别是如果血清阳性个体认为自己具有免疫力。在The Lancet Infectious Diseases中，国家SARS-CoV-2血清学检测评估组1首次对四种广泛使用的商业检测方法和一种内部检测方法的性能进行了大型比较研究。针对SARS-CoV-2的抗体反应主要针对病毒进入所需的刺突糖蛋白和结合病毒RNA基因组的核衣壳蛋白。SARS-CoV-2 IgG检测试剂盒（Abbott，芝加哥，IL，USA）和Elecsys Anti-SARS-CoV-2检测试剂盒（Roche，巴塞尔，瑞士）检测核蛋白抗体，而LIAISON SARS-CoV-2 S1/S2 IgG检测试剂盒（DiaSorin，萨卢贾，意大利）和SARS-CoV-2 Total检测试剂盒（Siemens，慕尼黑，德国）检测刺突糖蛋白抗体。Abbott和Diasorin检测试剂盒仅检测IgG，而Roche和Siemens检测总抗体。四种商业检测方法所采取的不同方法突出了实验室面临的选择挑战：所有制造商都报告了类似的高灵敏度和特异性。作者比较了这四种检测方法和一种新的384孔ELISA检测总IgG与三聚体刺突蛋白，并对2014年至2016年收集的976份假定为阴性的大流行前样本使用了所有五种检测方法，以及536份来自英国牛津研究中实验室确诊的COVID-19患者或血浆捐献者的血清样本。作者报告称，所有检测方法均具有较高的灵敏度（92.7 - 99.1%）和特异性（98.7 - 99.9%）。评估的最敏感的检测是内部ELISA。雅培罗氏
Diagnosing previous infection with respiratory viruses is challenging. Our understanding of individual and population-level immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) remains incomplete and developing reliable serological assays to detect previous infection has been an intense focus of the global scientific effort. For public health planning we need scalable assays validated against large banks of samples from individuals who had proven seasonal (non-severe acute respiratory syndrome) coronaviruses and those who had well characterised symptomatic and asymptomatic confirmed SARS-CoV-2 infection. False-positive results, due to cross-reactivity with seasonal coronaviruses, are important to avoid, particularly if seropositive-individuals consider themselves immune. In The Lancet Infectious Diseases, the National SARS-CoV-2 Serology Assay Evaluation Group1 provide the first large comparative investigation of the performance of four widely available commercial assays and a single in-house assay. Antibody responses to SARS-CoV-2 are predominantly directed at the spike glycoprotein, which the virus requires for entry, and the nucleocapsid protein, which binds the viral RNA genome. The SARS-CoV-2 IgG assay (Abbott, Chicago, IL, USA) and Elecsys Anti-SARS-CoV-2 assay (Roche, Basel, Switzerland) assays detect antibody to the nucleoprotein, whereas the LIAISON SARS-CoV-2 S1/S2 IgG assay (DiaSorin, Saluggia, Italy), and SARS-CoV-2 Total assay (Siemens, Munich, Germany) detect antibodies to the spike glycoprotein. The Abbott and Diasorin assays detect IgG only, whereas Roche and Siemens detect total antibody. The diverse approaches taken by the four commercial assays highlight the challenge of choice posed to laboratories: all manufacturers report similarly high sensitivity and specificity.The authors compared these four assays and a novel 384-well ELISA detecting total IgG to a trimeric spike protein and used all five assays on 976 pre-pandemic samples presumed to be negative, collected between 2014 and 2016, and 536 serum samples from patients with laboratory-confirmed COVID-19 from research studies in Oxford, UK, or plasma donors. The authors report that all assays had a high sensitivity (92· 7-99· 1%) and specificity (98· 7-99· 9%). The most sensitive test assessed was the in-house ELISA. The Abbott, Roche,