McDonald Lindsay, Wise Helen, Muecksch Frauke, Poston Daniel, Mavin Sally, Templeton Kate, Furrie Elizabeth, Richardson Claire, McGuire Jaqueline, Jarvis Lisa, Malloy Kristen, McAuley Andrew, Palmateer Norah, Dickson Elizabeth, Hatziioannou Theodora, Bieniasz Paul, Jenks Sara
Royal Infirmary of Edinburgh, NHS Lothian, Edinburgh, Scotland.
Laboratory of Retrovirology, The Rockefeller University, New York, New York, USA.
J Clin Virol Plus. 2021 Sep;1(3):100028. doi: 10.1016/j.jcvp.2021.100028. Epub 2021 Jun 14.
Sero-surveillance of SARS-CoV-2 is crucial to monitoring levels of population exposure and informing public health responses, but may be influenced by variability in performance between available assays.
Five commercial immunoassays and a neutralising activity assay were used to detect antibodies to SARS-CoV-2 in routine primary care and paediatric samples collected during the first wave of the pandemic in NHS Lothian, Scotland as part of ongoing surveillance efforts. For each assay, sensitivity and specificity was calculated relative to consensus results (majority of immunoassays positive = overall positive) and neutralising activity. Quantitative correlation was performed between serological and neutralising titres.
Seroprevalence ranged from 3.4-7.3 % in primary care patients and 3-5.9 % in paediatric patients according to different immunoassays. Neutralising activity was detectable in 2.8 % and 1.3 % respectively. Relative assay performance changed depending on comparison to immunoassay consensus versus neutralising activity and qualititative versus quantitative agreement. Cross-reactivity with endemic seasonal coronaviruses was confirmed by neutralising assay in false positives for one immunoassay. Presence of false positives for another assay was found specifically in paediatric but not adult samples.
Five serological assays show variable accuracy when applied to the general population, impacting seroprevalence estimates. Assay performance may also vary in detection of protective neutralising antibody levels. These aspects should be considered in assay selection and interpretation in epidemiological studies.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的血清学监测对于监测人群暴露水平和为公共卫生应对提供信息至关重要，但可能会受到现有检测方法性能差异的影响。
作为正在进行的监测工作的一部分，在苏格兰NHS Lothian第一波疫情期间收集的常规初级保健和儿科样本中，使用了五种商业免疫测定法和一种中和活性测定法来检测SARS-CoV-2抗体。对于每种测定法，相对于共识结果（大多数免疫测定法呈阳性=总体呈阳性）和中和活性计算敏感性和特异性。对血清学滴度和中和滴度进行定量相关性分析。
根据不同的免疫测定法，初级保健患者的血清阳性率在3.4%-7.3%之间，儿科患者的血清阳性率在3%-5.9%之间。分别在2.8%和1.3%的样本中检测到中和活性。相对检测性能根据与免疫测定法共识与中和活性的比较以及定性与定量一致性而变化。通过中和试验在一种免疫测定法的假阳性结果中证实了与地方性季节性冠状病毒的交叉反应性。在另一种测定法中发现假阳性结果仅存在于儿科样本而非成人样本中。
五种血清学检测方法应用于一般人群时显示出不同的准确性，影响血清阳性率估计。检测保护性中和抗体水平时检测性能也可能有所不同。在流行病学研究的检测方法选择和解释中应考虑这些方面。
