在大流行前和大流行期间的患者人群中对两种自动化抗 SARS-CoV-2 免疫分析的分析和临床分析。

Analytical and Clinical Analysis of Two Automated Anti-SARS-CoV-2 Immunoassays in Pre-Pandemic and Pandemic Patient Populations.

机构信息

Department of Pathology and Laboratory Medicine, Pennsylvania State University College of Medicine, Hershey, PA, USA.

Automated Testing Lab, Penn State Health Hershey Medical Center, Hershey, PA, USA.

出版信息

J Appl Lab Med. 2021 Mar 1;6(2):441-450. doi: 10.1093/jalm/jfaa204.

DOI:10.1093/jalm/jfaa204

PMID:33152084

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7665559/

Abstract

BACKGROUND

In the absence of a safe, effective vaccine, the worldwide spread of COVID-19 (SARS-CoV-2) infection will continue. Laboratory tests with ideal precision, sensitivity, and specificity should be used in public health and clinical settings to gauge the extent of virus exposure. Toward this end, we evaluated the analytical and clinical performance of the Abbott SARS-CoV-2 IgG and the Roche Anti-SARS-CoV-2 immunoassays.

METHODS

Quality control, pooled COVID-19, and non-COVID-19 patient specimens were used for the imprecision study. Two hundred and forty-six specimens from 70 patients with COVID-19 diagnosis were tested to study the sensitivity. Seventy-three non-COVID-19 control specimens were measured to study the specificity. All specimens were analyzed by both assays.

RESULTS

Total analytic variability (CV) of the negative and positive controls were 5.5% and 3.6% for the Abbott assay and 4.5% and 1.9% for the Roche assay. Both assays demonstrated 100% qualitative reproducibility of negative and positive controls. The clinical specificities of the Abbott and the Roche assays were 100% (95% CI: 94%-100%) and 97% (95% CI: 90%-100%), respectively. The clinical sensitivities of the Abbott assay were 49% (95% CI: 41%-56%), 86% (95% CI: 74%-93%), and 100% (95% CI: 76%-100%) for samples collected at 0-6 days, 7-13 days, and ≥14 days after the first RT-PCR, while the sensitivities of the Roche assay were 55% (95% CI: 47%-62%), 86% (95% CI: 74%-93%), and 100% (95% CI: 76%-100%).

CONCLUSIONS

This study demonstrates similar analytical and clinical performance of the Abbott and the Roche SARS-CoV-2 antibody assays, but the Roche assay may be slightly more sensitive for patients tested within 0-6 days after first positive RT-PCR of SARS-CoV-2.COVID-19 is a respiratory infectious disease caused by SARS-CoV-2. Laboratory tests with ideal precision, sensitivity, and specificity should be used in public health and clinical settings. We analyzed analytical and clinical performance of the Roche and Abbott SARS-CoV-2 antibody assays in pre-pandemic and pandemic patient populations. Additionally, we analyzed the sensitivity of both assays in patients at different stages of the disease. The 2 assays showed similar analytical and clinical performance, but the Roche assay may be slightly more sensitive for patients tested within 0-6 days after first positive RT-PCR of SARS-CoV-2. Our findings help other clinical labs select appropriate assays for SARS-CoV-2 antibody testing.

摘要

背景

在没有安全、有效的疫苗的情况下，COVID-19（SARS-CoV-2）的全球传播将继续。在公共卫生和临床环境中，应使用具有理想精度、灵敏度和特异性的实验室检测来评估病毒暴露程度。为此，我们评估了 Abbott SARS-CoV-2 IgG 和罗氏 Anti-SARS-CoV-2 免疫分析的分析和临床性能。

方法

使用不理想精度的 COVID-19 、聚集 COVID-19 和非 COVID-19 患者标本进行不精密度研究。对 70 例 COVID-19 诊断患者的 246 份标本进行检测以研究敏感性。对 73 份非 COVID-19 对照标本进行测量以研究特异性。所有标本均由两种分析物进行分析。

结果

Abbott 分析物的阴性和阳性对照的总分析变异性（CV）分别为 5.5%和 3.6%，罗氏分析物的 CV 分别为 4.5%和 1.9%。两种分析物的阴性和阳性对照的定性重现性均为 100%。Abbott 和罗氏分析物的临床特异性分别为 100%（95%CI：94%-100%）和 97%（95%CI：90%-100%）。Abbott 分析物的临床灵敏度分别为 0-6 天、7-13 天和≥14 天采集的样本为 49%（95%CI：41%-56%）、86%（95%CI：74%-93%）和 100%（95%CI：76%-100%），罗氏分析物的灵敏度分别为 55%（95%CI：47%-62%）、86%（95%CI：74%-93%）和 100%（95%CI：76%-100%）。

结论

本研究表明 Abbott 和罗氏 SARS-CoV-2 抗体分析物具有相似的分析和临床性能，但罗氏分析物在检测 SARS-CoV-2 首次 RT-PCR 阳性后 0-6 天内的患者时可能略敏感。COVID-19 是一种由 SARS-CoV-2 引起的呼吸道传染病。在公共卫生和临床环境中，应使用具有理想精度、灵敏度和特异性的实验室检测。我们分析了 Abbott 和罗氏 SARS-CoV-2 抗体分析物在大流行前和大流行期间患者人群中的分析和临床性能。此外，我们分析了两种分析物在不同疾病阶段患者中的灵敏度。这两种分析物表现出相似的分析和临床性能，但罗氏分析物在检测 SARS-CoV-2 首次 RT-PCR 阳性后 0-6 天内的患者时可能略敏感。我们的研究结果有助于其他临床实验室选择用于 SARS-CoV-2 抗体检测的合适分析物。