SARS-CoV-2 lateral flow assays for possible use in national covid-19 seroprevalence surveys (React 2): diagnostic accuracy study.
SARS-CoV-2 lateral flow assays for possible use in national covid-19 seroprevalence surveys (React 2): diagnostic accuracy study.
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DOI：
10.1136/bmj.n423
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发表时间：
2021-03-02
期刊：
影响因子：
--
通讯作者：
React study team
中科院分区：
文献类型：
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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
评估适用于国家2019冠状病毒病（covid-19）血清流行规划的新型侧流免疫分析法（LFIAs）的性能（社区传播实时评估2 - react 2）。诊断准确性研究。实验室分析在英国伦敦帝国理工学院和伦敦大学设施进行。手指点刺取样的研究诊所在两个附属的NHS信托基金中运行。对320名既往参与React 2项目并确认既往感染过严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）的参与者的血清进行敏感性分析。对1000份大流行前血清样本进行了特异性分析。100名先前确诊为SARS-CoV-2感染的新参与者参加了研究诊所进行手指刺破测试。分别对来自确诊SARS-CoV-2感染的参与者的至少200份血清样本和500份大流行前血清样本进行了7次LFIAs的实验室敏感性和特异性分析。发现三个LFIA的实验室敏感性优于目前用于React 2血清阳性率研究的LFIA的手指刺痛敏感性（84%）。然后通过手指刺破测试对先前确诊的SARS-CoV-2感染的参与者进行进一步评估：2020年6月至7月在诊所评估了两个LFIA (Surescreen, Panbio)，并于2020年9月评估了第三个LFIA （AbC-19）。采用刺突蛋白酶联免疫法和杂交双抗原结合法作为实验室参考标准。LFIAs检测SARS-CoV-2免疫球蛋白G （IgG）抗体的准确性与两种参比标准的比较使用血清分析的7种新型LFIAs的敏感性和特异性分别为69%至100%和98.6%至100%（与两个参考标准相比）。与参比标准相比，Panbio的手指点刺检测灵敏度为77%(95%可信区间61.4% ~ 88.2%)，Surescreen为86% (72.7% ~ 94.8%)，AbC-19为69%（53.8% ~ 81.3%）。血清对AbC-19的敏感性显著高于手指刺检，为92% （80.0% ~ 97.7%，P=0.01）。抗体滴度在不同的队列中差异很大。在抗体滴度最低的四分之一处，手指刺检出的阳性样本数量在不同的LFIAs中有所不同。一种新的LFIA被确定具有临床性能，适合纳入血清阳性率研究。然而，测试的LFIA都没有明显优于目前用于React 2血清阳性率调查的LFIA，也没有表现出足够的敏感性和特异性，可以考虑常规临床使用。
To evaluate the performance of new lateral flow immunoassays (LFIAs) suitable for use in a national coronavirus disease 2019 (covid-19) seroprevalence programme (real time assessment of community transmission 2—React 2). Diagnostic accuracy study. Laboratory analyses were performed in the United Kingdom at Imperial College, London and university facilities in London. Research clinics for finger prick sampling were run in two affiliated NHS trusts. Sensitivity analyses were performed on sera stored from 320 previous participants in the React 2 programme with confirmed previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Specificity analyses were performed on 1000 prepandemic serum samples. 100 new participants with confirmed previous SARS-CoV-2 infection attended study clinics for finger prick testing. Laboratory sensitivity and specificity analyses were performed for seven LFIAs on a minimum of 200 serum samples from participants with confirmed SARS-CoV-2 infection and 500 prepandemic serum samples, respectively. Three LFIAs were found to have a laboratory sensitivity superior to the finger prick sensitivity of the LFIA currently used in React 2 seroprevalence studies (84%). These LFIAs were then further evaluated through finger prick testing on participants with confirmed previous SARS-CoV-2 infection: two LFIAs (Surescreen, Panbio) were evaluated in clinics in June-July 2020 and the third LFIA (AbC-19) in September 2020. A spike protein enzyme linked immunoassay and hybrid double antigen binding assay were used as laboratory reference standards. The accuracy of LFIAs in detecting immunoglobulin G (IgG) antibodies to SARS-CoV-2 compared with two reference standards. The sensitivity and specificity of seven new LFIAs that were analysed using sera varied from 69% to 100%, and from 98.6% to 100%, respectively (compared with the two reference standards). Sensitivity on finger prick testing was 77% (95% confidence interval 61.4% to 88.2%) for Panbio, 86% (72.7% to 94.8%) for Surescreen, and 69% (53.8% to 81.3%) for AbC-19 compared with the reference standards. Sensitivity for sera from matched clinical samples performed on AbC-19 was significantly higher with serum than finger prick at 92% (80.0% to 97.7%, P=0.01). Antibody titres varied considerably among cohorts. The numbers of positive samples identified by finger prick in the lowest antibody titre quarter varied among LFIAs. One new LFIA was identified with clinical performance suitable for potential inclusion in seroprevalence studies. However, none of the LFIAs tested had clearly superior performance to the LFIA currently used in React 2 seroprevalence surveys, and none showed sufficient sensitivity and specificity to be considered for routine clinical use.
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