Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia.
Development of Serological Assays and Seroprevalence Studies of the New Coronavirus 2019 (COVID-19): Reports from Saudi Arabia.
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DOI：
10.3390/healthcare9121730
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发表时间：
2021-12-14
期刊：
影响因子：
--
通讯作者：
Faizo AA
中科院分区：
文献类型：
--
作者：
Alandijany TA;Faizo AA
血清学分析是跟踪新冠肺炎传播、估计群体免疫力和评估疫苗效力的宝贵工具。沙特阿拉伯的几份报告描述了能够检测SARS-CoV-2特异性抗体并测量其中和活性的优化的内部方案。值得注意的是，用于开发和验证这些免疫分析的方法在样本量、验证方法和统计分析方面存在差异。建立了基于病毒全长尖峰蛋白(S)、S1亚基和核衣壳蛋白(NP)的酶联免疫分析(ELISA)，并能检测到IgM和/或免疫球蛋白G。ELISA通过使用当地SARS-CoV-2临床分离株的微量中和试验、FDA批准的商用免疫分析和/或实时聚合酶链式反应(RT-PCR)进行评估和验证。总体而言，所描述的检测方法的性能很高，达到了100%的灵敏度和98.9%的特异度，与其他冠状病毒没有交叉反应。随后，内部免疫分析以及商业上可用的试剂盒被应用于一些血清流行病学研究，旨在评估当地人群的血清阳性状态，包括医护人员、新冠肺炎患者、非新冠肺炎患者和健康献血者。报告的血清阳性率在这些研究中差异很大，从0.00%到32.2%不等。这些差异可能是由于研究时间、目标人群、样本大小和所用免疫分析的性能所致。事实上，在封锁期间，健康的献血者中报告了缺乏血清阳性病例，而报告的比率在该国新冠肺炎病例数量达到峰值时达到最高，特别是在转诊医院和隔离点工作的医护人员中。在这篇综述中，我们的目标是(1)对已开发的内部免疫分析方法进行批判性讨论，(2)总结血清流行病学研究的主要结果，并强调每项研究的优点和缺点。
Serological assays are valuable tools for tracking COVID-19 spread, estimation of herd immunity, and evaluation of vaccine effectiveness. Several reports from Saudi Arabia describe optimized in-house protocols that enable detection of SARS-CoV-2 specific antibodies and measurement of their neutralizing activity. Notably, there were variations in the approaches utilized to develop and validate these immunoassays in term of sample size, validation methodologies, and statistical analyses. The developed enzyme-linked immunoassays (ELISAs) were based on the viral full-length spike (S), S1 subunit, and nucleocapsid (NP), and enabled detection of IgM and/or IgG. ELISAs were evaluated and validated against a microneutralization assay utilizing a local SARS-CoV-2 clinical isolate, FDA-approved commercially available immunoassays, and/or real-time polymerase chain reaction (RT-PCR). Overall, the performance of the described assays was high, reaching up to 100% sensitivity and 98.9% specificity with no cross-reactivity with other coronaviruses. In-house immunoassays, along with commercially available kits, were subsequently applied in a number of sero-epidemiological studies aiming to estimate sero-positivity status among local populations including healthcare workers, COVID-19 patients, non-COVID-19 patients, and healthy blood donors. The reported seroprevalence rates differed widely among these studies, ranging from 0.00% to 32.2%. These variations are probably due to study period, targeted population, sample size, and performance of the immunoassays utilized. Indeed, lack of sero-positive cases were reported among healthy blood donors during the lockdown, while the highest rates were reported when the number of COVID-19 cases peaked in the country, particularly among healthcare workers working in referral hospitals and quarantine sites. In this review, we aim to (1) provide a critical discussion about the developed in-house immunoassays, and (2) summarize key findings of the sero-epidemiological studies and highlight strengths and weaknesses of each study.
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影响因子：
4.2
作者：
Djaileb, Abdelhadi;Jodaylami, Maryam Hojjat;Masson, Jean-Francois
通讯作者：
Masson, Jean-Francois
影响因子：
2.2
作者：
Frumence E;Lebeau G;Viranaicken W;Dobi A;Vagner D;Lalarizo Rakoto M;Sandenon Seteyen AL;Giry C;Septembre-Malaterre A;Raffray L;Gasque P
通讯作者：
Gasque P
影响因子：
2.2
作者：
Krähling V;Halwe S;Rohde C;Becker D;Berghöfer S;Dahlke C;Eickmann M;Ercanoglu MS;Gieselmann L;Herwig A;Kupke A;Müller H;Neubauer-Rädel P;Klein F;Keller C;Becker S
通讯作者：
Becker S
影响因子：
12.7
作者：
Kohmer, Niko;Westhaus, Sandra;Rabenau, Holger F.
通讯作者：
Rabenau, Holger F.
影响因子：
2.2
作者：
Mahallawi WH
通讯作者：
Mahallawi WH