Background We explore SARS-CoV-2 antibody lateral flow immunoassay (LFIA) performance under field conditions compared to laboratory-based electrochemiluminescence immunoassay (ECLIA) and live virus neutralisation. 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 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 neutralisation. 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 neutralisation was detected in 169 of 250 randomly selected samples (67.6%); 133/169 were positive with self-reported LFIA (sensitivity 78.7%; 95% CI 71.8, 84.6), 142/155 (91.6%; 86.1, 95.5) with ALFA, and 169 (100%; 97.8, 100.0) with ECLIA. There were 81 samples with no detectable virus neutralisation; 47/81 were negative with self-reported LFIA (specificity 58.0%; 95% CI 46.5, 68.9), 34/75 (45.3%; 33.8, 57.3) with ALFA, and 0/81 (0%; 0.0, 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 neutralisation.

中文翻译：

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通过侧流免疫分析快速检测 SARS-CoV-2 抗体在家进行自我检测的有效性


背景 我们探讨了 SARS-CoV-2 抗体侧流免疫测定 (LFIA) 在现场条件下的性能与实验室电化学发光免疫测定 (ECLIA) 和活病毒中和的比较。方法 2021 年 7 月，3758 名参与者在家中对指尖采血进行了自我管理的 Fortress LFIA，报告并提交了结果照片，并提供了自我采集的毛细血管血样本，用于使用罗氏公司评估 IgG 抗体Elecsys® 抗 SARS-CoV-2 ECLIA。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 名参与者的子样本中，我们将结果与活病毒中和进行了比较。结果几乎所有参与者（3593/3758，95.6%）都已接种疫苗或报告既往感染。总体而言，2777/3758 (73.9%) 的自我报告 LFIA 呈阳性，2811/3457 (81.3%) 的 ALFA 报告的 LFIA 呈阳性，3622/3758 (96.4%) 的 ECLIA 呈阳性（使用制造商参考标准阈值） 0.8 U ml−1 的阳性率）。随机抽取的 250 个样本中有 169 个检测到活病毒中和（67.6%）； 133/169 例患者自我报告的 LFIA 呈阳性（敏感性 78.7%；95% CI 71.8, 84.6），142/155 例（91.6%；86.1, 95.5）的 ALFA 呈阳性，169 例（100%；97.8, 100.0）的 ECLIA 呈阳性。有 81 个样本未检测到病毒中和；自我报告 LFIA 的结果为 47/81 阴性（特异性 58.0%；95% CI 46.5, 68.9），ALFA 的结果为 34/75（45.3%；33.8, 57.3），而 LFIA 的结果为 0/81（0%；0.0, 4.5）。 ECLIA。结论 自我管理的 LFIA 不如定量抗体检测敏感，但 LFIA 的阳性率比定量 ECLIA 与病毒中和的相关性更好。