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首页> 外文期刊>The journal of applied laboratory medicine. >Specificity and Confirmation of SARS-CoV-2 Serological Test Methods in Emergency Department Populations across the United States?
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Specificity and Confirmation of SARS-CoV-2 Serological Test Methods in Emergency Department Populations across the United States?

机译：SARS-CoV-2 血清学检测方法在美国各地急诊科人群中的特异性和确认？

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Abstract Background Serological testing for SARS-CoV-2 is integral for understanding prevalence of disease, tracking of infections, confirming humoral response to vaccines, and determining timing and efficacy of boosters. The study objective was to compare the specificity of serology assays in emergency department populations across the United States in 2019 (pre-pandemic) and early 2020, incorporating an automated confirmatory assay.Methods Patient specimens (n = 1954) were from 4 regions in the United States: New York, NY; Milwaukee, WI; Miami, FL; and Los Angeles, CA. Specimens were tested with SARS-CoV-2 anti-spike receptor-binding domain assays: SARS-CoV-2 IgG on the Abbott Alinity i (AdviseDx SARS-Cov-2 IgG II) and Beckman Coulter Access 2 (SARS-CoV-2 IgG II), and SARS-CoV-2 IgM on the Abbott Alinity i (AdviseDx SARS-CoV-2 IgM). Reactive samples were tested with a research use only angiotensin-converting enzyme 2 binding inhibition assay (Abbott ARCHITECT) for confirmation of SARS-CoV-2 neutralizing antibodies. Assay specificity was determined and comparisons performed with Fisher’s exact test.Results Overall SARS-CoV-2 IgG specificity was 99.28% (95% confidence interval, 98.80%–99.61%), 99.39% (98.93%–99.68%), and 99.44% (98.99%–99.72%) for SARS-CoV-2 IgG by Abbott and Beckman, and SARS-CoV-2 IgM, respectively. Overall agreement for the two IgG assays was 99.28% (range for the 4 sites: 98.21% to 100%). There were no specificity differences between assays or sites.Conclusions The specificity of the serological assays evaluated in a large, diverse emergency department population was >99% and did not vary by geographical site. A confirmatory algorithm with an automated pseudo-neutralization assay allowed testing on the same specimen while reducing the false positivity rate and increasing the value of serology screening methods.
机译：抽象的背景血清学检测SARS-CoV-2是积分的理解感染疾病的患病率,跟踪,确认对疫苗的体液反应,确定时间和助推器的效果。研究的目的是比较的特异性在急诊科血清学检测在2019年美国人口(电视台),2020年初,将一个自动化的验证性试验。标本(n = 1954)来自4个地区美国:纽约,纽约;佛罗里达州迈阿密,;测试SARS-CoV-2 anti-spike受体结合域化验:SARS-CoV-2免疫球蛋白我(阿伯特Alinity AdviseDx SARS-Cov-2免疫球蛋白II)和贝克曼库尔特访问2 (SARS-CoV-2免疫球蛋白II),我和SARS-CoV-2 IgM雅培Alinity(AdviseDx SARS-CoV-2 IgM)。只测试一个研究使用血管紧张素转换酶2绑定Abbott抑制试验(架构师)确认SARS-CoV-2中和抗体。比较与费舍尔的确切执行测试。为99.28%(95%置信区间,99.44% (98.99% - -99.72%) SARS-CoV-2免疫球蛋白艾伯特和贝克曼,SARS-CoV-2 IgM,分别。4网站化验是99.28%(范围:98.21%100%)。化验或网站。的特异性血清学检测评估在一个大的多样化的急诊室人口是> 99%,不随地理的网站。一个自动pseudo-neutralization分析允许的测试在同一标本而减少假积极率和增加的价值血清学筛查方法。

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