Acceptability, Usability, and Performance of Lateral Flow Immunoassay Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies: REACT-2 Study of Self-Testing in Nonhealthcare Key Workers.
Acceptability, Usability, and Performance of Lateral Flow Immunoassay Tests for Severe Acute Respiratory Syndrome Coronavirus 2 Antibodies: REACT-2 Study of Self-Testing in Nonhealthcare Key Workers.
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DOI：
10.1093/ofid/ofab496
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发表时间：
2021-11
影响因子：
4.2
通讯作者：
Cooke G
中科院分区：
文献类型：
--
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
血清阳性率研究对于了解严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)的流行病学至关重要。有多种技术可用于抗体检测，包括实验室化验和护理点自我检测。对血清抗体效价研究的解释需要抗体检测性能的对比数据。2020年6月，英国警察和消防部门的现任和前任成员进行了自我检测侧向流动免疫分析(LFIA)，进行了护士进行的LFIA，并提供了用于酶联免疫吸附分析(ELISA)的静脉血液样本。我们介绍了SARS-CoV-2抗体的流行率以及自检LFIA的可接受性和可用性，并与实验室ELISA进行了比较，确定了LFIA的敏感性和特异性。在5189名现任和前任警队成员和263名消防队成员中，7.4%(5348人中的396人；95%可信区间[CI]，6.7-8.1)呈抗体阳性。40岁以下人群血清阳性率为8.9%(95%CI，6.9~11.4)，非白人人群为11.5%(95%CI，8.8~15.0)，在职人群为7.8%(95%CI，7.1~8.7)。自测LFIA的可接受性为97.7%，可用性为90.0%。受试者内部LFIA结果基本一致(kappa为0.80；95%可信区间为0.77-0.83)。与ELISA法相比，LFIA的敏感性为82.1%(95%CI，77.7~86.0)，护士自身检测的敏感性为76.4%(95%CI，71.9~80.5)，特异性分别为97.8%(95%CI，97.3~98.2)和98.5%(95%CI，98.1~98.8)。在英国的第一波疫情后，这一非医疗保健关键工作者队列中有更大比例的人显示出以前感染过SARS-CoV-2的证据，高于普通人群的6.0%(95%可信区间，5.8-6.1)。参与者报告的高可接受性和可用性以及自测和护士执行的LFIA的相似表现表明，自测LFIA适合于职业和社区患病率研究中的家庭测试。自测侧向流动免疫分析(LFIA)具有较高的可接受性和可用性，其性能与护士进行的LFIA相似。自测LFIA适合在非医疗工作者人群中进行SARS-CoV-2流行率研究中的家庭检测。
Seroprevalence studies are essential to understand the epidemiology of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Various technologies, including laboratory assays and point-of-care self-tests, are available for antibody testing. The interpretation of seroprevalence studies requires comparative data on the performance of antibody tests. In June 2020, current and former members of the United Kingdom police forces and fire service performed a self-test lateral flow immunoassay (LFIA), had a nurse-performed LFIA, and provided a venous blood sample for enzyme-linked immunosorbent assay (ELISA). We present the prevalence of antibodies to SARS-CoV-2 and the acceptability and usability of self-test LFIAs, and we determine the sensitivity and specificity of LFIAs compared with laboratory ELISA. In this cohort of 5189 current and former members of the police service and 263 members of the fire service, 7.4% (396 of 5348; 95% confidence interval [CI], 6.7–8.1) were antibody positive. Seroprevalence was 8.9% (95% CI, 6.9–11.4) in those under 40 years, 11.5% (95% CI, 8.8–15.0) in those of nonwhite ethnicity, and 7.8% (95% CI, 7.1–8.7) in those currently working. Self-test LFIA had an acceptability of 97.7% and a usability of 90.0%. There was substantial agreement between within-participant LFIA results (kappa 0.80; 95% CI, 0.77–0.83). The LFIAs had a similar performance: compared with ELISA, sensitivity was 82.1% (95% CI, 77.7–86.0) self-test and 76.4% (95% CI, 71.9–80.5) nurse-performed with specificity of 97.8% (95% CI, 97.3–98.2) and 98.5% (95% CI, 98.1–98.8), respectively. A greater proportion of this nonhealthcare key worker cohort showed evidence of previous infection with SARS-CoV-2 than the general population at 6.0% (95% CI, 5.8–6.1) after the first wave in England. The high acceptability and usability reported by participants and similar performance of self-test and nurse-performed LFIAs indicate that the self-test LFIA is fit for purpose for home testing in occupational and community prevalence studies. Self-test lateral flow immunoassays (LFIAs) had a high acceptability and usability and similar performance to nurse-performed LFIAs. Self-test LFIAs are suitable for home-testing in SARS-CoV-2 prevalence studies in nonhealthcare worker populations.
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DOI：
10.1136/bmj.n423
发表时间：
2021-03-02
期刊：
BMJ (Clinical research ed.)
影响因子：
--
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：
1.9
作者：
LANDIS, JR;KOCH, GG
通讯作者：
KOCH, GG
影响因子：
--
作者：
Riley, Steven;Atchison, Christina;Elliott, Paul
通讯作者：
Elliott, Paul
影响因子：
10
作者：
Flower, Barnaby;Brown, Jonathan C.;Cooke, Graham S.
通讯作者：
Cooke, Graham S.
DOI：
10.1093/cid/ciab004
发表时间：
2021-08-02
期刊：
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子：
--
作者：
Lumley SF;Wei J;O'Donnell D;Stoesser NE;Matthews PC;Howarth A;Hatch SB;Marsden BD;Cox S;James T;Peck LJ;Ritter TG;de Toledo Z;Cornall RJ;Jones EY;Stuart DI;Screaton G;Ebner D;Hoosdally S;Crook DW;Conlon CP;Pouwels KB;Walker AS;Peto TEA;Walker TM;Jeffery K;Eyre DW;Oxford University Hospitals Staff Testing Group
通讯作者：
Oxford University Hospitals Staff Testing Group