Commercial Serology Assays Predict Neutralization Activity against SARS-CoV-2
Commercial Serology Assays Predict Neutralization Activity against SARS-CoV-2
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DOI：
10.1093/clinchem/hvaa262
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发表时间：
2021-02-01
影响因子：
9.3
通讯作者：
Fitzgerald, Robert L.
中科院分区：
文献类型：
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作者：
Suhandynata, Raymond T.;Hoffman, Melissa A.;Fitzgerald, Robert L.
背景：目前尚不清楚血清学阳性结果是否与针对SARS-CoV-2的保护性免疫相关。此外，人们还担心SARS-CoV-2血清学检测的阳性预测值较低，特别是在检测低患病率人群时。方法：在一组pcr确认的阳性标本和阴性队列中验证中和试验。此外，采用Diazyme SARS-CoV-2 IgG血清学方法筛选9530份标本，并采用中和试验、罗氏总免疫球蛋白试验和雅培IgG试验对所有阳性结果（N = 164例）进行再分析。测定了SARS-CoV-2血清学阳性程度与中和活性之间的关系。还对经PCR确诊的SARS-CoV-2患者的中和抗体滴度（50%抑制稀释，ID50）进行了纵向监测。结果：SARS-CoV-2中和试验与SARS-CoV-2 PCR检测的阳性率（PPA）为96.6%，100例阴性对照的阴性百分率（NPA）为98.0%。ID50中和滴度与3个临床血清学平台呈正相关。对住院的pcr确诊COVID-19患者的纵向监测表明，他们对SARS-CoV-2具有高中和滴度。Diazyme IgG检测与中和检测之间的PPA为50.6%，而Diazyme IgG检测与罗氏或雅培平台联合使用的PPA分别为79.2%和78.4%。结论：这3项临床血清学检测与COVID-19患者观察到的SARS-CoV-2中和活性呈正相关。所有经PCR证实为SARS-CoV-2阳性的患者均产生中和抗体。
BACKGROUND: It is unknown whether a positive serology result correlates with protective immunity against SARS-CoV-2. There are also concerns regarding the low positive predictive value of SARS-CoV-2 serology tests, especially when testing populations with low disease prevalence.METHODS: A neutralization assay was validated in a set of PCR-confirmed positive specimens and in a negative cohort. In addition, 9530 specimens were screened using the Diazyme SARS-CoV-2 IgG serology assay and all positive results (N = 164 individuals) were reanalyzed using the neutralization assay, the Roche total immunoglobin assay, and the Abbott IgG assay. The relationship between the magnitude of a positive SARS-CoV-2 serology result and neutralizing activity was determined. Neutralizing antibody titers (50% inhibitory dilution, ID50) were also longitudinally monitored in patients confirmed to have SARS-CoV-2 by PCR.RESULTS: The SARS-CoV-2 neutralization assay had a positive percentage agreement (PPA) of 96.6% with a SARS-CoV-2 PCR test and a negative percentage agreement (NPA) of 98.0% across 100 negative control individuals. ID50 neutralization titers positively correlated with all 3 clinical serology platforms. Longitudinal monitoring of hospitalized PCR-confirmed patients with COVID-19 demonstrated they made high neutralization titers against SARS-CoV-2. PPA between the Diazyme IgG assay alone and the neutralization assay was 50.6%, while combining the Diazyme IgG assay with either the Roche or Abbott platforms increased the PPA to 79.2 and 78.4%, respectively.CONCLUSIONS: These 3 clinical serology assays positively correlate with SARS-CoV-2 neutralization activity observed in patients with COVID-19. All patients confirmed SARS-CoV-2 positive by PCR develop neutralizing antibodies.