Validity of Self-testing at Home With Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Detection by Lateral Flow Immunoassay.
Validity of Self-testing at Home With Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Detection by Lateral Flow Immunoassay.
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DOI：
10.1093/cid/ciac629
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发表时间：
2023-02-18
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影响因子：
--
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中科院分区：
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我们探讨了严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）抗体侧流免疫测定（LFIA）在现场条件下的性能相比，基于实验室的电化学发光免疫测定（ECLIA）和活病毒中和。2021年7月，3758名参与者在家中对手指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液样本，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。几乎所有参与者（3593/3758，95.6%）都接种过疫苗或报告过既往感染。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份样本未检出病毒中和;自我报告的LFIA（特异性58.0%; 95% CI：46.5，68.9）、ALFA（45.3%; 95% CI：33.8，57.3）和ECLIA（0%; 95% CI：0，4.5）中有47/81份为阴性。自我管理的LFIA比定量抗体检测灵敏度低，但LFIA的阳性相关性优于定量ECLIA与病毒中和。我们发现侧流免疫分析（LFIA）的阳性率与病毒中和的相关性优于定量电化学发光免疫分析（ECLIA）。校准到适当的阳性阈值，以保护免受感染或疾病，快速抗体家庭检测LFIA可能证明是有用的，在正在进行的人口监测。
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. 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. 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. 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. We found positivity on lateral flow immunoassay (LFIA) correlates better than quantitative electrochemiluminescence immunoassay (ECLIA) with virus neutralization. Calibrated to the appropriate positivity threshold for protection from infection or disease, rapid antibody home-testing by LFIA may prove useful in ongoing population surveillance.
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影响因子：
4.2
作者：
Davies B;Araghi M;Moshe M;Gao H;Bennet K;Jenkins J;Atchison C;Darzi A;Ashby D;Riley S;Barclay W;Elliott P;Ward H;Cooke G
通讯作者：
Cooke G
DOI：
10.1136/bmj.n423
发表时间：
2021-03-02
期刊：
BMJ (Clinical research ed.)
影响因子：
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作者：
Moshe M;Daunt A;Flower B;Simmons B;Brown JC;Frise R;Penn R;Kugathasan R;Petersen C;Stockmann H;Ashby D;Riley S;Atchison C;Taylor GP;Satkunarajah S;Naar L;Klaber R;Badhan A;Rosadas C;Marchesin F;Fernandez N;Sureda-Vives M;Cheeseman H;O'Hara J;Shattock R;Fontana G;Pallett SJC;Rayment M;Jones R;Moore LSP;Ashrafian H;Cherapanov P;Tedder R;McClure M;Ward H;Darzi A;Elliott P;Cooke GS;Barclay WS;React study team
通讯作者：
React study team
影响因子：
--
作者：
通讯作者：
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影响因子：
3.7
作者：
Hendelman T;Chaudhary A;LeClair AC;van Leuven K;Chee J;Fink SL;Welch EJ;Berthier E;Quist BA;Wald A;Wener MH;Hoofnagle AN;Morishima C
通讯作者：
Morishima C
影响因子：
82.9
作者：
Wei, Jia;Pouwels, Koen B.;Stoesser, Nicole;Matthews, Philippa C.;Diamond, Ian;Studley, Ruth;Rourke, Emma;Cook, Duncan;Bell, John, I;Newton, John N.;Farrar, Jeremy;Howarth, Alison;Marsden, Brian D.;Hoosdally, Sarah;Jones, E. Yvonne;Stuart, David, I;Crook, Derrick W.;Peto, Tim E. A.;Walker, A. Sarah;Eyre, David W.
通讯作者：
Eyre, David W.