商业血清学检测可预测针对 SARS-CoV-2 的中和活性。

Commercial Serology Assays Predict Neutralization Activity against SARS-CoV-2.

机构信息

Department of Pathology, UC San Diego Health, San Diego, CA.

Department of Immunology and Microbiology, The Scripps Research Institute, San Diego, CA.

出版信息

Clin Chem. 2021 Jan 30;67(2):404-414. doi: 10.1093/clinchem/hvaa262.

DOI:10.1093/clinchem/hvaa262

PMID:33084854

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7665417/

Abstract

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.

摘要

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，尤其是在检测疾病流行率较低的人群时。

方法

我们对一组经 PCR 确证的阳性标本和阴性队列中的中和检测进行了验证。此外，我们使用 Diazyme SARS-CoV-2 IgG 血清学检测对 9530 份标本进行了筛查，所有阳性结果（N=164 人）均使用中和检测、罗氏总免疫球蛋白检测和 Abbott IgG 检测进行了重新分析。我们还确定了 SARS-CoV-2 血清学阳性结果的幅度与中和活性之间的关系。PCR 确证的 SARS-CoV-2 患者的中和抗体滴度（50%抑制稀释度，ID50）也进行了纵向监测。

结果

SARS-CoV-2 中和检测与 SARS-CoV-2 PCR 检测的阳性百分比符合率（PPA）为 96.6%，与 100 名阴性对照个体的阴性百分比符合率（NPA）为 98.0%。ID50 中和滴度与所有 3 种临床血清学平台均呈正相关。对住院的经 PCR 确证的 COVID-19 患者进行的纵向监测表明，他们对 SARS-CoV-2 产生了高滴度的中和抗体。单独使用 Diazyme IgG 检测与中和检测的 PPA 为 50.6%，而将 Diazyme IgG 检测与罗氏或 Abbott 平台相结合时，PPA 分别提高到 79.2%和 78.4%。