Case Western Reserve University School of Medicine, Cleveland, United States.
These authors contributed equally to this work.
Euro Surveill. 2023 May;28(21). doi: 10.2807/1560-7917.ES.2023.28.21.2200809.
BackgroundSerological surveys have been the gold standard to estimate numbers of SARS-CoV-2 infections, the dynamics of the epidemic, and disease severity. Serological assays have decaying sensitivity with time that can bias their results, but there is a lack of guidelines to account for this phenomenon for SARS-CoV-2.AimOur goal was to assess the sensitivity decay of seroassays for detecting SARS-CoV-2 infections, the dependence of this decay on assay characteristics, and to provide a simple method to correct for this phenomenon.MethodsWe performed a systematic review and meta-analysis of SARS-CoV-2 serology studies. We included studies testing previously diagnosed, unvaccinated individuals, and excluded studies of cohorts highly unrepresentative of the general population (e.g. hospitalised patients).ResultsOf the 488 screened studies, 76 studies reporting on 50 different seroassays were included in the analysis. Sensitivity decay depended strongly on the antigen and the analytic technique used by the assay, with average sensitivities ranging between 26% and 98% at 6 months after infection, depending on assay characteristics. We found that a third of the included assays departed considerably from manufacturer specifications after 6 months.ConclusionsSeroassay sensitivity decay depends on assay characteristics, and for some types of assays, it can make manufacturer specifications highly unreliable. We provide a tool to correct for this phenomenon and to assess the risk of decay for a given assay. Our analysis can guide the design and interpretation of serosurveys for SARS-CoV-2 and other pathogens and quantify systematic biases in the existing serology literature.
背景
血清学调查一直是估计 SARS-CoV-2 感染人数、疫情动态和疾病严重程度的金标准。血清学检测随着时间的推移会逐渐降低其敏感性，从而可能导致其结果出现偏差，但目前缺乏针对 SARS-CoV-2 血清学检测的敏感性衰减进行校正的指南。
目的
我们旨在评估用于检测 SARS-CoV-2 感染的血清学检测的敏感性衰减情况，以及这种衰减与检测特性的依赖性，并提供一种简单的方法来纠正这种现象。
方法
我们进行了一项关于 SARS-CoV-2 血清学研究的系统评价和荟萃分析。我们纳入了检测先前确诊、未接种疫苗的个体的研究，并排除了队列研究中高度不能代表一般人群的研究（例如住院患者）。
结果
在筛选出的 488 项研究中，有 76 项研究报告了 50 种不同的血清学检测方法，这些研究被纳入了分析。敏感性衰减强烈取决于抗原和检测中使用的分析技术，根据检测特性的不同，感染后 6 个月的平均敏感性范围在 26%至 98%之间。我们发现，有三分之一的纳入检测方法在 6 个月后与制造商的规格有很大差异。
结论
血清学检测的敏感性衰减取决于检测特性，对于某些类型的检测方法，制造商的规格可能变得非常不可靠。我们提供了一种工具来校正这种现象，并评估给定检测方法的衰减风险。我们的分析可以指导 SARS-CoV-2 和其他病原体的血清学调查的设计和解释，并量化现有血清学文献中的系统性偏差。
