School of Public Health, Imperial College London, London, United Kingdom.
Imperial College Healthcare NHS Trust, London, United Kingdom.
Clin Infect Dis. 2023 Feb 18;76(4):658-666. doi: 10.1093/cid/ciac629.
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.
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。
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