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家用快速严重急性呼吸综合征冠状病毒 2 抗体侧向流动免疫检测的有效性。

Validity of Self-testing at Home With Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Detection by Lateral Flow Immunoassay.

机构信息

School of Public Health, Imperial College London, London, United Kingdom.

Imperial College Healthcare NHS Trust, London, United Kingdom.

出版信息

Clin Infect Dis. 2023 Feb 18;76(4):658-666. doi: 10.1093/cid/ciac629.


DOI:10.1093/cid/ciac629
PMID:35913410
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9384551/
Abstract

BACKGROUND: We explore severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody lateral flow immunoassay (LFIA) performance under field conditions compared to laboratory-based electrochemiluminescence immunoassay (ECLIA) and live virus neutralization. METHODS: In July 2021, 3758 participants performed, at home, a self-administered Fortress LFIA on finger-prick blood, reported and submitted a photograph of the result, and provided a self-collected capillary blood sample for assessment of immunoglobulin G (IgG) antibodies using the Roche Elecsys® Anti-SARS-CoV-2 ECLIA. We compared the self-reported LFIA result to the quantitative ECLIA and checked the reading of the LFIA result with an automated image analysis (ALFA). In a subsample of 250 participants, we compared the results to live virus neutralization. RESULTS: Almost all participants (3593/3758, 95.6%) had been vaccinated or reported prior infection. Overall, 2777/3758 (73.9%) were positive on self-reported LFIA, 2811/3457 (81.3%) positive by LFIA when ALFA-reported, and 3622/3758 (96.4%) positive on ECLIA (using the manufacturer reference standard threshold for positivity of 0.8 U mL-1). Live virus neutralization was detected in 169 of 250 randomly selected samples (67.6%); 133/169 were positive with self-reported LFIA (sensitivity 78.7%; 95% confidence interval [CI]: 71.8, 84.6), 142/155 (91.6%; 95% CI: 86.1, 95.5) with ALFA, and 169 (100%; 95% CI: 97.8, 100.0) with ECLIA. There were 81 samples with no detectable virus neutralization; 47/81 were negative with self-reported LFIA (specificity 58.0%; 95% CI: 46.5, 68.9), 34/75 (45.3%; 95% CI: 33.8, 57.3) with ALFA, and 0/81 (0%; 95% CI: 0, 4.5) with ECLIA. CONCLUSIONS: Self-administered LFIA is less sensitive than a quantitative antibody test, but the positivity in LFIA correlates better than the quantitative ECLIA with virus neutralization.

摘要

背景:我们在现场条件下比较了严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)抗体侧向流动免疫分析(LFIA)与基于实验室的电化学发光免疫分析(ECLIA)和活病毒中和的性能。

方法:2021 年 7 月,3758 名参与者在家中自行用指尖采血进行 Fortress LFIA,报告并提交结果照片,并提供自行采集的毛细血管血样,使用罗氏 Elecsys® Anti-SARS-CoV-2 ECLIA 评估免疫球蛋白 G(IgG)抗体。我们将自我报告的 LFIA 结果与定量 ECLIA 进行比较,并使用自动图像分析(ALFA)检查 LFIA 结果的读数。在 250 名参与者的亚样本中,我们将结果与活病毒中和进行比较。

结果:几乎所有参与者(3758 名中的 3593 名,95.6%)均已接种疫苗或报告有先前感染。总体而言,3758 名中的 2777 名(73.9%)自我报告 LFIA 阳性,3457 名中的 2811 名(81.3%)经 ALFA 报告 LFIA 阳性,3758 名中的 3622 名(96.4%)ECLIA 阳性(使用制造商参考标准阳性阈值为 0.8 U mL-1)。在随机选择的 250 个样本中检测到 169 个活病毒中和;133/169 个样本(78.7%;95%置信区间[CI]:71.8, 84.6)用自我报告 LFIA 阳性,155 个中的 142 个(91.6%;95%CI:86.1, 95.5)用 ALFA,169 个中的 169 个(100%;95%CI:97.8, 100.0)用 ECLIA。有 81 个样本未检测到病毒中和;47/81 个(58.0%;95%CI:46.5, 68.9)自我报告 LFIA 阴性,75 个中的 34 个(45.3%;95%CI:33.8, 57.3)用 ALFA,81 个中的 0 个(0%;95%CI:0, 4.5)用 ECLIA。

结论:自我管理的 LFIA 不如定量抗体测试敏感,但阳性率比定量 ECLIA 与病毒中和的相关性更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec22/9938742/d9b145c72bf2/ciac629f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec22/9938742/1724e793e671/ciac629f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec22/9938742/d9b145c72bf2/ciac629f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec22/9938742/1724e793e671/ciac629f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec22/9938742/d9b145c72bf2/ciac629f2.jpg

相似文献

[1]
Validity of Self-testing at Home With Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Detection by Lateral Flow Immunoassay.

Clin Infect Dis. 2023-2-18

[2]
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Rev Inst Med Trop Sao Paulo. 2022

[3]
Development of receptor binding domain-based double-antigen sandwich lateral flow immunoassay for the detection and evaluation of SARS-CoV-2 neutralizing antibody in clinical sera samples compared with the conventional virus neutralization test.

Talanta. 2023-4-1

[4]
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[5]
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Front Public Health. 2020

[6]
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[7]
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J Clin Virol. 2020-6-15

[8]
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[9]
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[10]
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引用本文的文献

[1]
Design and Implementation of a National Program to Monitor the Prevalence of SARS-CoV-2 IgG Antibodies in England Using Self-Testing: The REACT-2 Study.

Am J Public Health. 2023-11

[2]
SARS-CoV-2 rapid antibody test results and subsequent risk of hospitalisation and death in 361,801 people.

Nat Commun. 2023-8-16

[3]
Association of Results of Four Lateral Flow Antibody Tests with Subsequent SARS-CoV-2 Infection.

Microbiol Spectr. 2022-10-26

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