Validity of self-testing at home with rapid SARS-CoV-2 antibody detection by lateral flow immunoassay
Validity of self-testing at home with rapid SARS-CoV-2 antibody detection by lateral flow immunoassay
复制标题
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
DOI：
10.1101/2022.06.08.22276154
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Atchison C
中科院分区：
文献类型：
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作者：
Atchison C
研究背景严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗体侧流免疫测定（LFIA）在现场条件下的性能与基于实验室的电化学发光免疫测定（ECLIA）和活病毒中和相比。方法2021年7月，3758名参与者在家中对手指刺血进行了自我管理的Fortress LFIA，报告并提交了结果照片，并提供自行采集的毛细血管血液样品，用于使用Roche 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结果的阅读。在一个子样本的250名参与者，我们比较了结果活病毒neutralization.ResultsAlmost所有的参与者（3593/3758，95.6%）已接种疫苗或报告以前的感染。总体而言，2777/3758例（73.9%）在自我报告的LFIA上呈阳性，2811/3457例（81.3%）在ALFA报告时LFIA呈阳性，3622/3758例（96.4%）在ECLIA上呈阳性（使用0.8 U mL-1的生产商参考标准阈值）。在250份随机抽取的样本中，有169份检测到活病毒中和（67.6%）; 133/169例自我报告的LFIA阳性（灵敏度78.7%; 95%置信区间[CI]：71.8，84.6），ALFA组142/155（91.6%; 95% CI：86.1，95.5），ECLIA组169（100%; 95% CI：97.8，100.0）。有81份样本未检测到病毒中和; 47/81份自我报告的LFIA为阴性（特异性58.0%; 95%CI：46.5，68.9），34/75（45.3%; 95% CI：33.8，57.3），使用ALFA，0/81（0%; 95% CI：0，4.5）与ECLIA.ConclusionsSelf-administered LFIA的灵敏度低于定量抗体试验，但LFIA的阳性与病毒中和的相关性优于定量ECLIA。
BackgroundWe 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.MethodsIn 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.ResultsAlmost 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.ConclusionsSelf-administered LFIA is less sensitive than a quantitative antibody test, but the positivity in LFIA correlates better than the quantitative ECLIA with virus neutralization.