Herd immunity

群体免疫
  • 文章类型: Journal Article
    随着疫苗的社会价值日益得到认可,有必要研究可用于将这些不同益处纳入疫苗经济评估的方法学方法.
    文献综述和两次专家小组会议探讨了评估群体免疫力的方法,健康溢出效应(超越群体免疫),对抗菌素耐药性的影响,疫苗的生产率和公平性影响。
    在经济评估中考虑疫苗的更广泛利益是复杂的,需要技术专长。考虑到群体免疫力和工作效率的方法相对成熟,调查公平影响的方法正在发展,应用频率较低。模拟对抗菌素耐药性的潜在影响不仅取决于疫苗接种和耐药性之间的多方面因果关系。还有数据可用性。
    可以使用不同的方法来评估疫苗的广泛影响,重要的是分析师要意识到其优势和局限性,并证明其选择方法的合理性。在未来,我们预计,越来越多的经济评估将考虑疫苗的更广泛的利益,作为其基础案例分析或敏感性分析的一部分。
    UNASSIGNED: As the societal value of vaccines is increasingly recognized, there is a need to examine methodological approaches that could be used to integrate these various benefits in the economic evaluation of a vaccine.
    UNASSIGNED: A literature review and two expert panel meetings explored methodologies to value herd immunity, health spillover effects (beyond herd immunity), impact on antimicrobial resistance, productivity and equity implications of vaccines.
    UNASSIGNED: The consideration of broader benefits of vaccines in economic evaluation is complicated and necessitates technical expertise. Whereas methodologies to account for herd immunity and work productivity are relatively well established, approaches to investigate equity implications are developing and less frequently applied. Modelling the potential impact on antimicrobial resistance not only depends on the multi-faceted causal relationship between vaccination and resistance, but also on data availability.
    UNASSIGNED: Different methods are available to value the broad impact of vaccines and it is important that analysts are aware of their strengths and limitations and justify their choice of method. In the future, we expect that an increasing number of economic evaluations will consider the broader benefits of vaccines as part of their base-case analysis or in sensitivity analyses.
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  • 文章类型: Journal Article
    公共卫生系统报告说,东亚严重急性呼吸道综合症冠状病毒2(SARS-CoV-2)的死亡率很低,在低收入国家,以及SARS-CoV-2大流行第一年的儿童。这些报告使评论员提出,先前暴露于其他病原体的交叉反应性免疫力降低了死亡风险。初始感染波的消退也有助于推测群体免疫在接种疫苗之前阻止了进一步的波。血清学反而暗示免疫太有限,无法实现群体免疫,交叉反应保护几乎没有影响。儿科死亡人数超过流感死亡人数,与人口相似地区相比,低收入国家的特定年龄死亡风险较高,东亚的死亡风险相似。爆发前暴露于相关病原体或由初始感染波引起的免疫都不一定是对未来病原体爆发的可靠反应。相反,对未来病原体暴发的准备应侧重于诸如自愿行为改变之类的策略,非药物干预措施,和疫苗接种。
    Public health systems reported low mortality from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in East Asia, in low-income countries, and for children during the first year of the SARS-CoV-2 pandemic. These reports led commentators to suggest that cross-reactive immunity from prior exposure to other pathogens reduced fatality risk. Resolution of initial infection waves also contributed to speculation that herd immunity prevented further waves prior to vaccination. Serology instead implied that immunity was too limited to achieve herd immunity and that there was little impact from cross-reactive protection. Paediatric deaths exceeded those from influenza, with higher age-specific fatality risk in lower-income nations and similar fatality risk in East Asia compared with demographically similar regions. Neither pre-outbreak exposure to related pathogens nor immunity induced by initial infection waves are necessarily a reliable response to future pathogen outbreaks. Preparedness for future pathogen outbreaks should instead focus on strategies such as voluntary behavioural changes, nonpharmaceutical interventions, and vaccination.
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  • 文章类型: Journal Article
    为了消除对实施甲型肝炎普遍大规模疫苗接种(UMV)策略的犹豫,并为医疗保健当局提供对实施此类疫苗接种计划的潜在结果和益处的全面分析,我们预测了俄罗斯联邦总人口中的HAV血清阳性率和发病率,并使用新的数学模型估计了达到每100,000例低于1例的发病率水平所需的儿科疫苗接种阈值.
    开发了动态年龄结构的SEIRV(易感-暴露-感染-恢复-接种疫苗)隔室模型,并使用人口统计进行了校准,血清阳性率,疫苗接种,和来自俄罗斯联邦不同地区的流行病学数据。该模型用于预测各种流行病学措施。
    预计处于人口免疫中点的全国平均年龄从2020年的40岁增加到2036年的50岁,并且在某些地区进一步转移到70岁。国家。如果HAV疫苗接种覆盖率保持在2022年的水平,则在2028年至2032年之间,所有研究地区和整个俄罗斯联邦的症状性HAV感染发病率预计将出现不同程度的增加。如果在实施UMV计划后接种1-6岁儿童,则到2032年达到每10万例有症状的HAV发病率低于1例的全国平均疫苗接种覆盖率为69.8%,如果将免疫范围扩大到1-17岁儿童,则为34.8%。
    开发的模型在持续病毒传播的背景下提供了对HAV的群体免疫力进一步下降的见解。如果疫苗接种覆盖率保持在目前水平,目前甲型肝炎发病率的有利情况预计将被发病率的增加所取代。获得的结果支持在俄罗斯联邦引入甲型肝炎UMV策略。
    UNASSIGNED: To combat the hesitancy towards implementing a hepatitis A universal mass vaccination (UMV) strategy and to provide healthcare authorities with a comprehensive analysis of the potential outcomes and benefits of the implementation of such a vaccination program, we projected HAV seroprevalence and incidence rates in the total population of the Russian Federation and estimated the pediatric vaccination threshold required to achieve an incidence level of less than 1 case per 100,000 using a new mathematical model.
    UNASSIGNED: A dynamic age-structured SEIRV (susceptible-exposed-infectious-recovered-vaccinated) compartmental model was developed and calibrated using demographic, seroprevalence, vaccination, and epidemiological data from different regions of the Russian Federation. This model was used to project various epidemiological measures.
    UNASSIGNED: The projected national average age at the midpoint of population immunity increases from 40 years old in 2020 to 50 years old in 2036 and is shifted even further to the age of 70 years in some regions of the country. An increase of varying magnitude in the incidence of symptomatic HAV infections is predicted for all study regions and for the Russian Federation as a whole between 2028 and 2032, if the HAV vaccination coverage level remains at the level of 2022. The national average vaccination coverage level required to achieve a symptomatic HAV incidence rate below 1 case per 100,000 by 2032 was calculated to be 69.8% if children aged 1-6 years are vaccinated following the implementation of a UMV program or 34.8% if immunization is expanded to children aged 1-17 years.
    UNASSIGNED: The developed model provides insights into a further decline of herd immunity to HAV against the background of ongoing viral transmission. The current favorable situation regarding hepatitis A morbidity is projected to be replaced by an increase in incidence rates if vaccination coverage remains at the current levels. The obtained results support the introduction of a hepatitis A UMV strategy in the Russian Federation.
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  • 文章类型: Journal Article
    在合格人群中普遍不愿意接受COVID-19疫苗接种,这是尼日利亚争取实现群体对这一流行病的免疫力的严重挫折。
    我们评估了多学科健康沟通干预(MHCI)对NsukkaUrban合格未接种疫苗的社区居民(EUCD)接受COVID-19疫苗接种意愿的影响,埃努古州,尼日利亚。
    通过采用预先测试的准实验,测试后,非控制组设计,我们共研究了85名符合条件的未接种疫苗的成年人.研究人员设计的“接受COVID-19疫苗接种问卷的意愿”是用于数据收集的工具。收集的数据通过社会科学统计软件包(SPSS)23.0版进行了分析。具体来说,使用描述性和推断性统计来检验制定的研究问题和0.05显著性水平的假设。
    我们发现接受COVID-19疫苗接种意愿的平均得分在治疗后显著增加。性别没有显著的交互作用,教育水平,和年龄与MHCI后接受EUCDCOVID-19疫苗接种评分的意愿有关。
    该研究确定MHCI在支持接受COVID-19疫苗接种的意愿方面具有影响力。尼日利亚政府应该在学校采取和实施这种干预措施,社区,和其他机构,以便在尼日利亚获得群体豁免权。
    UNASSIGNED: The prevailing unwillingness to accept COVID-19 vaccination among the eligible population has been a serious setback in Nigeria\'s bid to reach herd immunity against the pandemic.
    UNASSIGNED: We assessed the impact of a multidisciplinary health communication intervention (MHCI) on willingness to accept COVID-19 vaccination among eligible unvaccinated community dwellers (EUCD) in Nsukka Urban, Enugu State, Nigeria.
    UNASSIGNED: Through a quasi-experiment that adopted a pre-test, post-test, non-control group design, we studied a total of 85 eligible unvaccinated adults. A researcher-designed \"Willingness to Accept COVID-19 Vaccination Questionnaire\" was the instrument used for data collection. The data gathered was analysed by means of Statistical Package for Social Sciences (SPSS) version 23.0. Specifically, descriptive and inferential statistics were used to test the formulated research questions and the hypothesis at 0.05 level of significance.
    UNASSIGNED: We found that the mean scores of willingness to accept COVID-19 vaccination increased significantly after the treatment. There was no significant interaction effect of gender, level of education, and age on the mean of willingness to accept COVID-19 vaccination scores of EUCD after MHCI.
    UNASSIGNED: The study established that MHCI is impactful in bolstering the willingness to accept COVID-19 vaccination. The Nigerian government should adopt and implement this intervention in schools, communities, and other institutions in order to attain herd immunity in Nigeria.
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  • 文章类型: Journal Article
    背景:现在和将来,像COVID-19这样的空气传播疾病可能变得无法控制,并导致世界陷入封锁。寻找封锁的替代方案,限制个人自由,造成巨大的经济损失,是至关重要的。
    目的:本研究的目的是评估通过大规模生产和分销高性能,在空气传播传染病大流行期间实现不需要封锁的社会或国家的可行性,低成本,和舒适的动力空气净化呼吸器(PAPRs)。
    方法:从以下角度研究了使用PAPR作为锁定替代方案的社会系统的可行性:首先,PAPR可以做什么来替代封锁;第二,如何利用PAPR操作社会系统;第三,PAPR的改进方向,作为封锁的替代方案;最后,通过使用物联网(IoT)来平衡感染控制效率和个人自由。
    结果:PAPR被证明是通过减少空气传播和液滴传播以及通过每次接触感染概率的暂时降低来替代锁定的可能选择。提出了一种社会制度,在该社会制度中,封锁所施加的个人约束被PAPR所取代,并给出了其运行实例。例如,政府决定封锁的类型和强度,并启动它。当时,政府还将说明如何用PAPR代替封锁期间施加的不同活动和行动限制,例如,如果穿着PAPR,可以允许外出,以代替宵禁令。提出以下7点作为改进PAPR作为锁定的替代方法的方向:流量优化,精确的压差控制,设计改进,维护方法,变化发展,如展位类型,信息终端功能,和绩效评价方法。为了在使用PAPR作为封锁替代方案的社会系统中实现高水平的控制感染传播和个人自由的有效性和效率,利用物联网开发PAPR磨损率网络管理系统被认为是有效的。
    结论:这项研究表明,在空气传播传染病大流行期间,使用具有感染控制能力且经济和社会损害较小的PAPR作为全国封锁的替代方案是可能的。Further,政府的感染控制效率和每个公民的自由可以通过使用PAPR磨损率网络管理系统利用物联网系统来平衡。
    BACKGROUND: Now and in the future, airborne diseases such as COVID-19 could become uncontrollable and lead the world into lockdowns. Finding alternatives to lockdowns, which limit individual freedoms and cause enormous economic losses, is critical.
    OBJECTIVE: The purpose of this study was to assess the feasibility of achieving a society or a nation that does not require lockdown during a pandemic due to airborne infectious diseases through the mass production and distribution of high-performance, low-cost, and comfortable powered air purifying respirators (PAPRs).
    METHODS: The feasibility of a social system using PAPR as an alternative to lockdown was examined from the following perspectives: first, what PAPRs can do as an alternative to lockdown; second, how to operate a social system utilizing PAPR; third, directions of improvement of PAPR as an alternative to lockdown; and finally, balancing between efficiency of infection control and personal freedom through the use of Internet of Things (IoT).
    RESULTS: PAPR was shown to be a possible alternative to lockdown through the reduction of airborne and droplet transmissions and through a temporary reduction of infection probability per contact. A social system in which individual constraints imposed by lockdown are replaced by PAPRs was proposed, and an example of its operation is presented in this paper. For example, the government determines the type and intensity of the lockdown and activates it. At that time, the government will also indicate how PAPR can be substituted for the different activity and movement restrictions imposed during a lockdown, for example, a curfew order may be replaced with the permission to go outside if wearing a PAPR. The following 7 points were raised as directions for improvement of PAPR as an alternative method to lockdown: flow optimization, precise differential pressure control, design improvement, maintenance method, variation development such as booth type, information terminal function, and performance evaluation method. In order to achieve the effectiveness and efficiency in controlling the spread of infection and the individual freedom at a high level in a social system that uses PAPRs as an alternative to lockdown, it was considered effective to develop a PAPR wearing rate network management system utilizing IoT.
    CONCLUSIONS: This study shows that using PAPR with infection control ability and with less economic and social damage as an alternative to nationwide lockdown is possible during a pandemic due to airborne infectious diseases. Further, the efficiency of the government\'s infection control and each citizen\'s freedom can be balanced by using the PAPR wearing rate network management system utilizing an IoT system.
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  • 文章类型: Journal Article
    背景:COVID-19可能成为一种季节性疾病。SARS-CoV-2活跃的循环加上疫苗接种的努力无疑改变了病毒的动态。因此,在时空变异和免疫接种过程中,研究不同人群中SARS-CoV-2的动态非常重要。
    方法:调查不同种族的SARS-CoV-2清除率和免疫接种的影响,我们招募了777名SARS-CoV-2阳性患者(570名非洲人,156名高加索人,和51名亚洲人)。参与者被跟踪并定期测试2个月,直到他们有两个阴性测试。
    结果:接种率为64.6%。非洲个体症状较少(2%),白种人(41%)和亚洲人(36.6%)。平均而言,病毒清除发生在10.5天后.诊断时的病毒载量与病毒清除率呈负相关(p<0.0001)。非洲人和白种人的SARS-CoV-2清除时间高于亚洲人(邓恩检验p<0.0001和p<0.05)。平均而言,病毒清除发生在第二学期的9.5天内(更高的疫苗接种率和SARS-CoV-2暴露),而在第一学期花费了13.6天(疫苗接种率和SARS-CoV-2暴露率较低)(Mann-Whitneyt检验p<0.0001)。
    结论:结论:包括SARS-CoV-2暴露和免疫在内的种族和时空变化会影响SARS-CoV-2的清除。
    BACKGROUND: COVID-19 may become a seasonal disease. SARS-CoV-2 active circulation coupled with vaccination efforts has undoubtedly modified the virus dynamic. It is therefore important investigate SARS-CoV-2 dynamic in different groups of population following the course of spatiotemporal variance and immunization.
    METHODS: To investigate SARS-CoV-2 clearance in different ethnic groups and the impact of immunization, we recruited 777 SARS-CoV-2-positive patients (570 Africans, 156 Caucasians, and 51 Asians). Participants were followed and regularly tested for 2 months until they had two negative tests.
    RESULTS: The vaccination rate was 64.6%. African individuals were less symptomatic (2%), Caucasians (41%) and Asians (36.6%). On average, viral clearance occurred after 10.5 days. Viral load at diagnosis was inversely correlated with viral clearance (p < 0.0001). The time of SARS-CoV-2 clearance was higher in Africans and Caucasians than in Asians (Dunn\'s test p < 0.0001 and p < 0.05, respectively). On average, viral clearance occurred within 9.5 days during the second semester (higher rate of vaccination and SARS-CoV-2 exposition), whereas it took 13.6 days during the first semester (lower rate of vaccination and SARS-CoV-2 exposition) (Mann-Whitney t-test p < 0.0001).
    CONCLUSIONS: In conclusion, ethnicity and spatiotemporal changes including SARS-CoV-2 exposition and immunization affect SARS-CoV-2 clearance.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    评估疫苗和其他传染病预防措施的人群水平效果对公共卫生领域很重要。在传染病研究中,一个人的治疗可能会影响另一个人的结果,也就是说,单位之间可能存在干扰。例如,一个人使用蚊帐预防疟疾可能会对居住在附近的其他个人产生间接影响。在某些设置中,个人可以形成群组或集群,其中干扰只发生在群组内,也就是说,有部分干扰。以前已经开发了逆概率加权估计器,用于部分干扰的观察研究。不幸的是,这些估计器不太适合大型集群的研究。因此,在本文中,扩展了参数g公式以允许部分干扰。针对总体效果,提出了G公式估计器,治疗时的效果,以及未经治疗时的影响。拟议的估计器可以容纳大的簇,并且不会遭受在没有干扰的情况下可能发生的g-null悖论。假设没有未测量的混杂因素,并且部分干扰采用特定形式(称为“弱分层干扰”),则得出所提出的估计量的大样本属性。进行了仿真研究,证明了所提出的估计器的有限样本性能。然后使用拟议的g公式估算器对刚果民主共和国的人口和健康调查进行分析,以评估使用蚊帐对疟疾的影响。
    Assessing population-level effects of vaccines and other infectious disease prevention measures is important to the field of public health. In infectious disease studies, one person\'s treatment may affect another individual\'s outcome, that is, there may be interference between units. For example, the use of bed nets to prevent malaria by one individual may have an indirect effect on other individuals living in close proximity. In some settings, individuals may form groups or clusters where interference only occurs within groups, that is, there is partial interference. Inverse probability weighted estimators have previously been developed for observational studies with partial interference. Unfortunately, these estimators are not well suited for studies with large clusters. Therefore, in this paper, the parametric g-formula is extended to allow for partial interference. G-formula estimators are proposed for overall effects, effects when treated, and effects when untreated. The proposed estimators can accommodate large clusters and do not suffer from the g-null paradox that may occur in the absence of interference. The large sample properties of the proposed estimators are derived assuming no unmeasured confounders and that the partial interference takes a particular form (referred to as \'weak stratified interference\'). Simulation studies are presented demonstrating the finite-sample performance of the proposed estimators. The Demographic and Health Survey from the Democratic Republic of the Congo is then analyzed using the proposed g-formula estimators to assess the effects of bed net use on malaria.
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  • 文章类型: Journal Article
    COVID-19大流行,由SARS-CoV-2引起的,不成比例地影响了社会的某些阶层,特别是老年人(就疾病的严重程度而言,他们首当其冲地承受着大流行的负担,住院治疗,和死亡)。本研究提出了一个广义的多组模型,具有m个异质子种群,评估年龄异质性和疫苗接种对美国SARS-CoV-2大流行传播动态和控制的人群水平影响。对同质情况下的模型进行严格分析(即,m=1)的模型表明,每当相关的繁殖数小于1时,对于两个特殊情况(具有完美的疫苗效力或可忽略的疾病引起的死亡率),其无病平衡在全球范围内渐近稳定。该模型具有独特的全局渐近稳定的地方性均衡,对于特殊情况,当相关的再现阈值超过1时。使用美国在三个不同波期间观察到的累积死亡率数据拟合了均质模型(波A(2020年10月17日至2021年4月5日),B(2021年7月9日至2021年11月7日)和C(2022年1月1日至2022年5月7日)选择与Alpha,Delta和Omicron是,分别,在美国的主要变体。使用校准的模型来推导用于实现疫苗衍生的群体免疫(在美国消除疾病所需)的理论表达。事实证明,使用一组齐次模型,在美国大流行的C波期间,疫苗衍生的群体免疫是无法实现的,无论完全接种疫苗的个人的覆盖率如何。进行了全局敏感性分析,以确定对疾病动态和负担影响最大的模型参数。这些分析表明,在一个波浪中可能非常有效的控制和缓解策略在另一个波浪中可能不是那么有效。然而,针对无症状和症状前感染个体的策略在所有波中始终有效.为了研究COVID-19对老年人群的不成比例影响,我们考虑了将总人口细分为65岁以下个体和65岁及以上个体的亚群体的异质模型.由此产生的两组异构模型,这也是用C波的累积死亡率数据拟合的,也进行了严格的分析。与单组模型的情况不同,它被证明,对于两组模型,如果至少61%的民众完全接种疫苗,疫苗衍生的群体免疫确实可以在大流行的C波期间实现。因此,这项研究表明,在具有均匀混合的SARS-CoV-2疫苗接种模型中添加年龄异质性可显着降低实现疫苗衍生的群体免疫所需的疫苗接种覆盖率(特别是,对于异构模型,如果适度比例的易感个体完全接种疫苗,则可以在C波期间获得群体免疫)。该结果的结果是,未明确说明年龄异质性的SARS-CoV-2疫苗接种模型可能高估了消除SARS-CoV-2大流行所需的疫苗衍生的群体免疫阈值的水平。
    The COVID-19 pandemic, caused by SARS-CoV-2, disproportionately affected certain segments of society, particularly the elderly population (which suffered the brunt of the burden of the pandemic in terms of severity of the disease, hospitalization, and death). This study presents a generalized multigroup model, with m heterogeneous sub-populations, to assess the population-level impact of age heterogeneity and vaccination on the transmission dynamics and control of the SARS-CoV-2 pandemic in the United States. Rigorous analysis of the model for the homogeneous case (i.e., the model with m = 1) reveal that its disease-free equilibrium is globally-asymptotically stable for two special cases (with perfect vaccine efficacy or negligible disease-induced mortality) whenever the associated reproduction number is less than one. The model has a unique and globally-asymptotically stable endemic equilibrium, for special a case, when the associated reproduction threshold exceeds one. The homogeneous model was fitted using the observed cumulative mortality data for the United States during three distinct waves (Waves A (October 17, 2020 to April 5, 2021), B (July 9, 2021 to November 7, 2021) and C (January 1, 2022 to May 7, 2022)) chosen to align with time periods when the Alpha, Delta and Omicron were, respectively, the predominant variants in the United States. The calibrated model was used to derive a theoretical expression for achieving vaccine-derived herd immunity (needed to eliminate the disease in the United States). It was shown that, using the one-group homogeneous model, vaccine-derived herd immunity is not attainable during Wave C of the pandemic in the United States, regardless of the coverage level of the fully-vaccinated individuals. Global sensitivity analysis was carried out to determine the parameters of the model that have the most influence on the disease dynamics and burden. These analyses reveal that control and mitigation strategies that may be very effective during one wave may not be so very effective during the other wave or waves. However, strategies that target asymptomatic and pre-symptomatic infectious individuals are shown to be consistently effective across all waves. To study the impact of the disproportionate effect of COVID-19 on the elderly population, we considered the heterogeneous model for the case where the total population is subdivided into the sub-populations of individuals under 65 years of age and those that are 65 and older. The resulting two-group heterogeneous model, which was also fitted using the cumulative mortality data for wave C, was also rigorously analysed. Unlike for the case of the one-group model, it was shown, for the two-group model, that vaccine-derived herd immunity can indeed be achieved during Wave C of the pandemic if at least 61% of the populace is fully vaccinated. Thus, this study shows that adding age heterogeneity into a SARS-CoV-2 vaccination model with homogeneous mixing significantly reduces the level of vaccination coverage needed to achieve vaccine-derived herd immunity (specifically, for the heterogeneous model, herd-immunity can be attained during Wave C if a moderate proportion of susceptible individuals are fully vaccinated). The consequence of this result is that vaccination models for SARS-CoV-2 that do not explicitly account for age heterogeneity may be overestimating the level of vaccine-derived herd immunity threshold needed to eliminate the SARS-CoV-2 pandemic.
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  • 文章类型: Journal Article
    严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的抗体反应是多目标的,并且随时间变化。需要多重定量血清学测定以提供准确且稳健的血清阳性数据,用于在疫苗接种和/或感染期间建立血清学特征。我们在这里描述了基于电化学发光(ECL)的中尺度发现测定(MSD)的验证和评估,用于估计相对于SARS-CoV-2峰值的总和功能性IgG,人血清样品中的核衣壳和受体结合(RBD)蛋白,以建立SARS-CoV-2自然感染和突破性病例的血清学特征。9-PLEX测定按照ICH进行验证,EMA,和美国FDA指南使用一组血清样本,包括NIBSC/世卫组织参考小组(20/268)。该测定法在抑制测定法中显示出高特异性和选择性,其中同源抑制超过85%并且异源抑制低于10%。该测定还符合预定的精度接受标准(CV<20%),准确度(70-130%)和稀释线性。使用代表接种疫苗的血清样本(n=45)证明了该方法对血清学特征的适用性,感染和突破性病例。该方法能够建立不同的血清学特征,因此为疫苗接种或感染期间SARS-CoV-2的血清阳性率提供了潜在的工具。
    Antibody responses to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are multi-targeted and variable over time. Multiplex quantitative serological assays are needed to provide accurate and robust seropositivity data for the establishment of serological signatures during vaccination and or infection. We describe here the validation and evaluation of an electro-chemiluminescence (ECL)-based Mesoscale Discovery assay (MSD) for estimation of total and functional IgG relative to SARS-CoV-2 spike, nucleocapsid and receptor binding (RBD) proteins in human serum samples to establish serological signatures of SARS-CoV-2 natural infection and breakthrough cases. The 9-PLEX assay was validated as per ICH, EMA, and US FDA guidelines using a panel of sera samples, including the NIBSC/WHO reference panel (20/268). The assay demonstrated high specificity and selectivity in inhibition assays, wherein the homologous inhibition was more than 85% and heterologous inhibition was below 10%. The assay also met predetermined acceptance criteria for precision (CV < 20%), accuracy (70-130%) and dilutional linearity. The method\'s applicability to serological signatures was demonstrated using sera samples (n = 45) representing vaccinated, infected and breakthrough cases. The method was able to establish distinct serological signatures and thus provide a potential tool for seroprevalence of SARS-CoV-2 during vaccination or infection.
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