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罗氏新型冠状病毒快速抗体检测在接种个体样本中的评估。

Evaluation of the Roche SARS-CoV-2 Rapid Antibody Test in Samples from Vaccinated Individuals.

机构信息

Roche Diagnostics GmbH, Mannheim, Germany.

出版信息

Microbiol Spectr. 2022 Jun 29;10(3):e0270921. doi: 10.1128/spectrum.02709-21. Epub 2022 May 16.


DOI:10.1128/spectrum.02709-21
PMID:35575594
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9241600/
Abstract

The study aimed to establish the performance of the SARS-CoV-2 Rapid Antibody Test (IgG and IgM) and the Elecsys Anti-SARS-CoV-2 S assay in vaccinated individuals. A panel of serum samples from Boca Biolistics was utilized to assess antibodies following vaccination, consisting of samples drawn prior to vaccination, after the first dose, or at least 14 days after the second dose of Moderna mRNA-1273 or Pfizer-BioNTech BNT162b2 COVID-19 vaccines. Agreement between the two methods was measured and stratified by test evaluator and assay lot. Agreement between the SARS-CoV-2 Rapid Antibody Test (IgG) and Elecsys Anti-SARS-CoV-2 S assay qualitative measurements at the different assessment points for both mRNA-1273 and BNT162b2 ranged between 97.06% (95% confidence interval [CI] 84.67, 99.93) to 100% (95% CI 82.35, 100). Agreement of the SARS-CoV-2 Rapid Antibody Test (IgG) with the Elecsys Anti-SARS-CoV-2 S assay was not highly influenced by either lot or evaluator. There was a medium-to-strong correlation between the semiquantitative SARS-CoV-2 Rapid Antibody Test (IgG) result and quantitative Elecsys Anti-SARS-CoV-2 S assay in samples taken after both doses of the vaccines, with higher intensity bands being associated with higher total anti-S antibody titer (mRNA-1273, = 0.0019; BNT162b2, < 0.0001). Conclusion Semiquantitative SARS-CoV-2 Rapid Antibody Test (IgG) and quantitative Elecsys Anti-SARS-CoV-2 S assay correlated well, suggesting that the SARS-CoV-2 Rapid Antibody Test (IgG) is helpful in understanding the immune response postvaccination. The current data support the use of the SARS-CoV-2 Rapid Antibody Test (IgG) in the vaccinated population. Serologic assays are an essential tool for seroprevalence surveys, for quality control of vaccines, and to determine the response to vaccination. Although a correlate of immunity has not yet been established for COVID-19 vaccines, antibody titers after natural infection and vaccination have been associated with protection from symptomatic SARS-CoV-2 infection. Rapid point-of-care assays can be of use in this context with advantages over centralized testing, such as speed and ease of use. The point-of-care SARS-CoV-2 Rapid Antibody Test (IgG) compared favorably to the Elecsys Anti-SARS-CoV-2 S assay with agreement rates above 97.06%, after one or two doses of Moderna mRNA-1273 or Pfizer-BioNTech BNT162b2. Semiquantitative SARS-CoV-2 Rapid Antibody Test (IgG) and quantitative Elecsys Anti-SARS-CoV-2 S assay results correlated well, suggesting that SARS-CoV-2 Rapid Antibody Test (IgG) is helpful in understanding the immune response postvaccination. The current data support the use of the SARS-CoV-2 Rapid Antibody Test (IgG) in the vaccinated population.

摘要

本研究旨在评估 SARS-CoV-2 快速抗体检测(IgG 和 IgM)和 Elecsys Anti-SARS-CoV-2 S 检测在接种疫苗人群中的表现。利用 Boca Biolistics 的一组血清样本评估疫苗接种后的抗体,样本包括接种前、第一剂后或至少在 Moderna mRNA-1273 或 Pfizer-BioNTech BNT162b2 COVID-19 疫苗接种后第二剂后 14 天采集的样本。通过评估者和检测批次评估两种方法的一致性。两种方法在评估 Moderna mRNA-1273 和 BNT162b2 疫苗接种后不同时间点的 SARS-CoV-2 快速抗体检测(IgG)和 Elecsys Anti-SARS-CoV-2 S 检测的定性测量之间的一致性在 97.06%(95%置信区间 [CI] 84.67, 99.93)至 100%(95%CI 82.35, 100)之间。SARS-CoV-2 快速抗体检测(IgG)与 Elecsys Anti-SARS-CoV-2 S 检测之间的一致性不受批次或评估者的影响。在接受两剂疫苗后的样本中,SARS-CoV-2 快速抗体检测(IgG)的半定量结果与 Elecsys Anti-SARS-CoV-2 S 检测的定量结果具有中度至强相关性,强度较高的条带与较高的总抗-S 抗体滴度相关(mRNA-1273, = 0.0019;BNT162b2, < 0.0001)。结论 SARS-CoV-2 快速抗体检测(IgG)和 Elecsys Anti-SARS-CoV-2 S 检测具有良好的相关性,表明 SARS-CoV-2 快速抗体检测(IgG)有助于了解疫苗接种后的免疫反应。目前的数据支持在接种人群中使用 SARS-CoV-2 快速抗体检测(IgG)。血清学检测是血清流行率调查、疫苗质量控制以及确定疫苗接种反应的重要工具。尽管尚未确定 COVID-19 疫苗的免疫相关因素,但自然感染和接种疫苗后的抗体滴度与对有症状 SARS-CoV-2 感染的保护有关。即时检测的快速点检测可以在这种情况下使用,具有比集中检测更快和更易用的优点。在接受 Moderna mRNA-1273 或 Pfizer-BioNTech BNT162b2 一剂或两剂后,SARS-CoV-2 快速抗体检测(IgG)与 Elecsys Anti-SARS-CoV-2 S 检测的一致性率超过 97.06%,优于 Elecsys Anti-SARS-CoV-2 S 检测。SARS-CoV-2 快速抗体检测(IgG)的半定量结果与 Elecsys Anti-SARS-CoV-2 S 检测的定量结果具有良好的相关性,表明 SARS-CoV-2 快速抗体检测(IgG)有助于了解疫苗接种后的免疫反应。目前的数据支持在接种人群中使用 SARS-CoV-2 快速抗体检测(IgG)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/5a36baab3f22/spectrum.02709-21-f003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/26380291c8e3/spectrum.02709-21-f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/79719dfcdd69/spectrum.02709-21-f002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/5a36baab3f22/spectrum.02709-21-f003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/26380291c8e3/spectrum.02709-21-f001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/79719dfcdd69/spectrum.02709-21-f002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b6ab/9241600/5a36baab3f22/spectrum.02709-21-f003.jpg

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本文引用的文献

[1]
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