两种自动化免疫分析检测 SARS-CoV-2 核衣壳抗体的比较。

Comparison of Two Automated Immunoassays for the Detection of SARS-CoV-2 Nucleocapsid Antibodies.

机构信息

Department of Pathology and Laboratory Medicine, Dartmouth-Hitchcock Health System, Lebanon, NH.

The Geisel School of Medicine at Dartmouth, Hanover, NH.

出版信息

J Appl Lab Med. 2021 Mar 1;6(2):429-440. doi: 10.1093/jalm/jfaa175.

DOI:10.1093/jalm/jfaa175

PMID:32976593

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7543392/

Abstract

BACKGROUND

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel member of the coronavirus family that caused the global coronavirus 2019 (COVID-19) pandemic. The prevalence remains largely unknown because of early testing supply shortages. Although it cannot currently be used to determine level of immunity, antibody testing can contribute to epidemiological studies, identify convalescent plasma donors, or satisfy curiosity about previous exposure to the virus.

METHODS

407 samples collected from hospitalized inpatients with and without a confirmed SARS-CoV-2 infection, 170 remnant clinical specimens collected and frozen prior to the COVID-19 outbreak, and paired serum and plasma samples from 23 convalescent plasma donors were used to determine performance characteristics of the Abbott SARS-CoV-2 IgG and Roche Elecsys Anti-SARS-CoV-2 assays. The sensitivity, specificity, imprecision, interferences, and sample stability were determined. These assays were then used to characterize the antibody response in serial samples from 20 SARS-CoV-2 positive inpatients.

RESULTS

Both assays exhibited 100% specificity (95% CI; 99.05-100.00), giving no positive results in 170 specimens collected before July 2019 and 215 specimens from patients without a confirmed SARS-CoV-2 infection. Differences between platforms were most notable in SARS-CoV-2 positive samples. Roche offered higher sensitivity in convalescent plasma donors at 95.7% (95% CI; 78.1-99.9) versus 91.3% (95% CI; 72.0-98.9) but Abbott detected antibodies in 2 immunocompromised patients whereas Roche did not. The Roche and Abbott platforms also exhibited different trends in antibody signal for a subset of patients.

CONCLUSIONS

Both the Abbott and Roche platforms offer excellent specificity but different trends in antibody signal may reflect qualitative differences in the types of antibodies recognized by the 2 assays. Negative serologic results do not exclude previous SARS-CoV-2 infection.

摘要

背景

严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）是冠状病毒家族的一种新型成员，导致了全球 2019 年冠状病毒病（COVID-19）大流行。由于早期检测供应短缺，其流行程度在很大程度上仍不清楚。尽管目前不能用于确定免疫水平，但抗体检测可以为流行病学研究做出贡献，确定恢复期血浆供体，或满足对以前接触该病毒的好奇心。

方法

使用来自住院的伴有和不伴有确诊 SARS-CoV-2 感染的患者的 407 份样本、COVID-19 爆发前收集并冷冻的 170 份剩余临床标本，以及 23 名恢复期血浆供体的配对血清和血浆样本，来确定 Abbott SARS-CoV-2 IgG 和 Roche Elecsys Anti-SARS-CoV-2 检测的性能特征。确定了灵敏度、特异性、不精密度、干扰和样本稳定性。然后，使用这些检测方法来描述 20 名 SARS-CoV-2 阳性住院患者的连续样本中的抗体反应。

结果

两种检测方法的特异性均为 100%（95%CI；99.05-100.00），在 2019 年 7 月前采集的 170 份标本和 215 份无确诊 SARS-CoV-2 感染的患者标本中均未出现阳性结果。在 SARS-CoV-2 阳性样本中，平台之间的差异最为明显。罗氏在恢复期血浆供体中的灵敏度更高，为 95.7%（95%CI；78.1-99.9），而 Abbott 为 91.3%（95%CI；72.0-98.9），但罗氏在 2 名免疫功能低下的患者中检测到抗体，而罗氏则没有。罗氏和 Abbott 平台在一组患者的抗体信号趋势上也表现出不同。