Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation.
Multi-center nationwide comparison of seven serology assays reveals a SARS-CoV-2 non-responding seronegative subpopulation.
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全国多中心对七种血清学检测方法的比较显示，SARS-CoV-2 的血清学检测结果显示，有一部分人血清学检测结果为阴性。
DOI：
10.1016/j.eclinm.2020.100651
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发表时间：
2020-12
影响因子：
15.1
通讯作者：
Lustig Y
中科院分区：
文献类型：
--
作者：
Oved K;Olmer L;Shemer-Avni Y;Wolf T;Supino-Rosin L;Prajgrod G;Shenhar Y;Payorsky I;Cohen Y;Kohn Y;Indenbaum V;Lazar R;Geylis V;Oikawa MT;Shinar E;Stoyanov E;Keinan-Boker L;Bassal R;Reicher S;Yishai R;Bar-Chaim A;Doolman R;Reiter Y;Mendelson E;Livneh Z;Freedman LS;Lustig Y
以色列国家工作组对七种血清学检测方法进行了多中心临床和分析验证，以确定其在 SARS-CoV-2 诊断中的效用和局限性。其中包括来自 Roche、Abbott、Diasorin、BioMerieux、Beckman-Coulter、Siemens 的血清学检测以及内部 RBD ELISA。对 2020 年 3 月至 5 月期间收集的代表以色列人口的 2391 名个人和 698 名 SARS-CoV-2 PCR 阳性患者的阴性样本进行了分析，免疫测定灵敏度在 81.5%-89.4% 之间，特异性在 97.7%-100% 之间，这对低（<15%）流行情况下的预期阳性预测值（PPV）产生了深远影响。与成人相比，儿童的假阳性率没有明显增加。疾病严重程度与抗体滴度呈正相关，并且在PCR阳性后的前8周内观察到抗体滴度没有下降。我们确定了一个有症状的 SARS-CoV-2 阳性患者亚组（约占患者的 5%），他们在多种抗原、同种型和技术方面均保持血清阴性。在低流行情况下，市售的自动免疫测定在性能和预期 PPV 方面表现出显着差异。 20 岁以下人群的低假阳性率表明，对先前 CoV 毒株的交叉反应免疫不太可能解释儿童较轻的病程。发现前 8 周内抗体滴度没有下降，这与 SARS-CoV-2 抗体半衰期较短的一些报告形成鲜明对比。在人群范围内使用多种检测方法，约 5% 的血清阴性无反应者代表了可能面临再次感染风险的患者比例。以色列卫生部。
An Israeli national taskforce performed a multi-center clinical and analytical validation of seven serology assays to determine their utility and limitations for SARS-CoV-2 diagnosis. Serology assays from Roche, Abbott, Diasorin, BioMerieux, Beckman-Coulter, Siemens, and an in-house RBD ELISA were included. Negative samples from 2391 individuals representative of the Israeli population, and 698 SARS-CoV-2 PCR positive patients, collected between March and May 2020, were analyzed Immunoassays sensitivities between 81.5%-89.4% and specificities between 97.7%-100% resulted in a profound impact on the expected Positive Predictive Value (PPV) in low (<15%) prevalence scenarios. No meaningful increase was detected in the false positive rate in children compared to adults. A positive correlation between disease severity and antibody titers, and no decrease in antibody titers in the first 8 weeks after PCR positivity was observed. We identified a subgroup of symptomatic SARS-CoV-2 positive patients (~5% of patients), who remained seronegative across a wide range of antigens, isotypes, and technologies. The commercially available automated immunoassays exhibit significant differences in performance and expected PPV in low prevalence scenarios. The low false-positivity rate in under 20′s suggests that cross-reactive immunity from previous CoV strains is unlikely to explain the milder disease course in children. Finding no decrease in antibody titers in the first 8 weeks is in contrast to some reports of short half-life for SARS-CoV-2 antibodies. The ~5% who were seronegative non-responders, using multiple assays in a population-wide manner, represents the proportion of patients that may be at risk for re-infection. Israel Ministry of Health.
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影响因子：
8
作者：
McAndrews, Kathleen M.;Dowlatshahi, Dara P.;Kalluri, Raghu
通讯作者：
Kalluri, Raghu
影响因子：
82.9
作者：
Long, Quan-Xin;Liu, Bai-Zhong;Huang, Ai-Long
通讯作者：
Huang, Ai-Long
影响因子：
7.3
作者：
Fierz, Walter;Walz, Brigitte
通讯作者：
Walz, Brigitte
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
DOI：
10.1172/jci142004
发表时间：
2020-11-02
期刊：
The Journal of clinical investigation
影响因子：
--
作者：
Klein, Sabra L;Pekosz, Andrew;Tobian, Aaron Ar
通讯作者：
Tobian, Aaron Ar