Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody lateral flow assay for antibody prevalence studies following vaccination: a diagnostic accuracy study.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody lateral flow assay for antibody prevalence studies following vaccination: a diagnostic accuracy study.
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DOI：
10.12688/wellcomeopenres.17231.2
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发表时间：
2021
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背景：横向流动免疫测定法（LFIAs）能够实现经济实惠的大规模抗体检测，并在没有中央实验室支持的情况下提供快速结果。作为REACT计划开发的一部分，对自然感染后的个体进行了LFIA性能的广泛评估。在这里，我们评估了选定的LFIA检测至少接受过一剂严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）疫苗的个体的抗体反应的性能。方法：这是一项前瞻性诊断准确性研究。抽样是在伦敦帝国理工学院NHS信托肾门诊诊所和卫生保健工作者测试点进行的。招募了两组患者；第一个队列是108名接受两剂SARS-CoV-2疫苗接种后就诊的肾移植患者，第二个队列是40名接受首次SARS-CoV-2疫苗接种并随后随访的医护人员。访问期间，在LFIA设备上分析手指刺血样本，同时发送配对静脉样本进行刺突蛋白（抗s）抗体的血清学评估。采用Abbott Architect SARS-CoV-2 IgG Quant II CMIA检测抗- s IgG。共收集186个配对样本。结果：LFIA检测SARS-CoV-2 IgG抗体的敏感性为92.0%(114/124；95%可信区间[CI] 85.7% ~ 96.1%)，特异性为93.6% (58/62；（使用7.10 BAU/ml的阳性阈值）结论：Fortress LFIA在人群水平监测的抗体反应检测中表现良好，但不符合个体检测标准。
Background: Lateral flow immunoassays (LFIAs) are able to achieve affordable, large scale antibody testing and provide rapid results without the support of central laboratories. As part of the development of the REACT programme extensive evaluation of LFIA performance was undertaken with individuals following natural infection. Here we assess the performance of the selected LFIA to detect antibody responses in individuals who have received at least one dose of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Methods: This was a prospective diagnostic accuracy study. Sampling was carried out at renal outpatient clinic and healthcare worker testing sites at Imperial College London NHS Trust. Two cohorts of patients were recruited; the first was a cohort of 108 renal transplant patients attending clinic following two doses of SARS-CoV-2 vaccine, the second cohort comprised 40 healthcare workers attending for first SARS-CoV-2 vaccination and subsequent follow up. During the participants visit, finger-prick blood samples were analysed on LFIA device, while paired venous sampling was sent for serological assessment of antibodies to the spike protein (anti-S) antibodies. Anti-S IgG was detected using the Abbott Architect SARS-CoV-2 IgG Quant II CMIA. A total of 186 paired samples were collected. The accuracy of Fortress LFIA in detecting IgG antibodies to SARS-CoV-2 compared to anti-spike protein detection on Abbott Assay Results: The LFIA had an estimated sensitivity of 92.0% (114/124; 95% confidence interval [CI] 85.7% to 96.1%) and specificity of 93.6% (58/62; 95% CI 84.3% to 98.2%) using the Abbott assay as reference standard (using the threshold for positivity of 7.10 BAU/ml) Conclusions: Fortress LFIA performs well in the detection of antibody responses for intended purpose of population level surveillance but does not meet criteria for individual testing.