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Evaluation of the clinical performance of BD SARS-CoV-2 flu assay for BD COR™ System BD严重急性呼吸系统综合征冠状病毒2型流感检测BD COR的临床性能评估™ 系统
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-10-17 DOI: 10.1016/j.jcvp.2023.100170
Elizabeth Lockamy, Rebekah M. Martin, Jordan Ippolito

Background

Differentiating between SARS-CoV-2 and Influenza (flu) A and B is often difficult without laboratory testing as the symptomology of these respiratory viral infections overlap.

Objective

Evaluate the clinical performance of the BD COR™ System multiplex assay (COR SC2/Flu) to detect the three viral pathogens using single nasopharyngeal (NP) swabs collected from symptomatic and asymptomatic individuals.

Materials and methods

Swabs collected from 203 symptomatic and 144 asymptomatic individuals were tested using COR SC2/Flu. Results were compared to those from the BioFire® Respiratory Panel 2.1 (BioFire RP2.1) and positive and negative percent agreements (PPA and NPA, respectively) with 95% confidence intervals were calculated.

Results

For asymptomatic individuals (n = 144), PPA between COR SC2/Flu and BioFire RP2.1 was 100% (95% CI: 79.6–100) and NPA was 97.7% (95% CI: 93.4–99.2) for the SARS-CoV-2 target. For symptomatic individuals (n = 203), PPA was 100% (95% CI: 92.9–100) and NPA 99.3% (95% CI: 96.4–99.9) for the SARS-CoV-2 target. PPA was 94.0% (95% CI: 83.8–97.9) and NPA was 98.7% (95% CI: 95.4–99.6) for the flu A target. PPA was 100% (95% CI: 92.9–100) and NPA was 100% (95% CI: 97.6–100) for flu B.

Conclusion

The continued development and validation of multiplex assays to detect SARS-CoV-2, flu A, and flu B should remain a crucial component of diagnostics as these viruses will continue to coexist in the post-pandemic environment. COR SC2/Flu assay performance met the predetermined clinical specifications for PPA and NPA for SARS-CoV-2, flu A, and flu B detection, and should help support infection control efforts of those diseases.

背景如果没有实验室检测,区分严重急性呼吸系统综合征冠状病毒2型和甲型和乙型流感通常很困难,因为这些呼吸道病毒感染的症状学重叠。目的评价BD COR的临床表现™ 系统多重检测(COR SC2/Flu),使用从有症状和无症状个体采集的单个鼻咽拭子检测三种病毒病原体。材料和方法从203名有症状和144名无症状个体中收集的拭子使用COR SC2/Flu进行检测。将结果与BioFire®呼吸面板2.1(BioFire RP2.1)的结果进行比较,并计算出95%置信区间的阳性和阴性百分比一致性(分别为PPA和NPA)。结果对于无症状个体(n=144),COR SC2/Flu和BioFire RP2.1之间的PPA对于严重急性呼吸系统综合征冠状病毒2型目标为100%(95%CI:79.6-100),NPA为97.7%(95%CI:93.4-99.2)。对于有症状的个体(n=203),严重急性呼吸系统综合征冠状病毒2型目标的PPA为100%(95%CI:92.9-100),NPA为99.3%(95%CI:96.4-99.9)。流感A靶点的PPA为94.0%(95%CI:83.8-97.9),NPA为98.7%(95%CI:95.4-99.6)。流感B的PPA为100%(95%CI:92.9-100),NPA为100%(95%CI:97.6-100)。结论继续开发和验证检测严重急性呼吸系统综合征冠状病毒2型、流感A型和流感B型的多重检测方法应仍然是诊断的重要组成部分,因为这些病毒将在大流行后的环境中继续共存。COR SC2/Flu检测性能符合用于检测严重急性呼吸系统综合征冠状病毒2型、甲型流感和乙型流感的PPA和NPA的预定临床规范,应有助于支持这些疾病的感染控制工作。
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引用次数: 0
Clinical performance evaluation of HCV and HIV-1 assays on the fully automated molecular system Alinity m 全自动分子系统Alinity m上HCV和HIV-1检测的临床性能评估
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-10-15 DOI: 10.1016/j.jcvp.2023.100169
Tung Phan , Zachary Cravener , Janet Olean , Melissa McCullough , Jamie Gribschaw , Alan Wells

The demand for molecular virology testing continues to grow in clinical laboratories worldwide. The Alinity m system is a fully automated, continuous, random-access molecular diagnostic analyzer that was designed to streamline the laboratory workflow. In this study, we assessed the clinical performance characteristics of the Alinity m HCV and HIV-1 assays to detect and quantify these two bloodborne pathogens in 71 serum and plasma specimens. The overall qualitative agreement between the Alinity m and Abbott m2000 was 100 % for HCV and 94.4 % for HIV-1. Our data demonstrated a weak bias across the quantitative range of the Abbott m2000 and Alinity m HCV and HIV-1 assays, indicating a strong correlation on viral loads between them. Taken together, the Alinity m HCV and HIV-1 assays had comparable results to their current predecessors, the Abbott RealTime HCV and HIV-1 assays.

全球临床实验室对分子病毒学检测的需求持续增长。Alinity m系统是一种全自动、连续、随机访问的分子诊断分析仪,旨在简化实验室工作流程。在本研究中,我们评估了Alinity m HCV和HIV-1检测的临床性能特征,以检测和量化71份血清和血浆标本中的这两种血源性病原体。Alinity m和Abbott m2000之间的总体定性一致性对HCV为100%,对HIV-1为94.4%。我们的数据表明,在Abbott m2000和Alinity m HCV和HIV-1检测的定量范围内存在微弱的偏差,表明它们之间的病毒载量有很强的相关性。总之,Alinity m HCV和HIV-1检测的结果与目前的前辈Abbott RealTime HCV和HIV1检测的结果相当。
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引用次数: 0
SARS-CoV-2 and chronic hepatitis B: Focusing on the possible consequences of co-infection 严重急性呼吸系统综合征冠状病毒2型和慢性乙型肝炎:关注共同感染的可能后果
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-10-14 DOI: 10.1016/j.jcvp.2023.100167
Shahrzad Shoraka , Seyed Reza Mohebbi , Seyed Masoud Hosseini , Amir Ghaemi , Mohammad Reza Zali

The pandemic of 2019 coronavirus disease (COVID-19) has become a world public health challenge. A new member of Coronaviridae family, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been identified as the causative of COVID-19. Although SARS-CoV-2 infection has a direct impact on the respiratory function, extra-respiratory complications such as liver damage have been reported in some cases. However, the exact mechanisms of liver injury in SARS-CoV-2 infection remain largely unexplored. It has also been suggested that patients with pre-existing liver disease are significantly influenced by COVID-19. Considering the double burden of chronic liver diseases and SARS-CoV-2 on health systems, investigating the interrelationship between COVID-19 and underlying liver disease and providing clear recommendations on treatment are very much needed.

Viral hepatitis is recognized as one of the substantial risk factors for chronic liver diseases. Hepatitis B virus (HBV) is a main cause of liver failure, cirrhosis and hepatocellular carcinoma (HCC). Since both HBV and SARS-CoV-2 affect liver physiology, investigating the possible interactions and effects of SARS-CoV-2/HBV co-infection is increasingly important. This review highlighted the molecular and clinical consequences of SARS-CoV-2/HBV co-infection.

2019冠状病毒病(新冠肺炎)的大流行已成为世界公共卫生的挑战。冠状病毒科的一个新成员被命名为严重急性呼吸综合征冠状病毒2(SARS-CoV-2),已被确定为新冠肺炎的病原体。尽管严重急性呼吸系统综合征冠状病毒2型感染对呼吸功能有直接影响,但据报道,在某些情况下会出现肝损伤等呼吸道外并发症。然而,严重急性呼吸系统综合征冠状病毒2型感染中肝损伤的确切机制在很大程度上尚未探索。也有人认为,已有肝病的患者受到新冠肺炎的显著影响。考虑到慢性肝病和SARS-CoV-2对卫生系统的双重负担,非常需要调查新冠肺炎与潜在肝病之间的相互关系,并提供明确的治疗建议。病毒性肝炎被认为是慢性肝病的主要危险因素之一。乙型肝炎病毒(HBV)是导致肝功能衰竭、肝硬化和肝细胞癌(HCC)的主要原因。由于HBV和严重急性呼吸系统综合征冠状病毒2型都会影响肝脏生理,研究严重急性呼吸系冠状病毒2型/HBV联合感染的可能相互作用和影响越来越重要。这篇综述强调了严重急性呼吸系统综合征冠状病毒2型/乙型肝炎病毒联合感染的分子和临床后果。
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引用次数: 0
Comparative evaluation of SARS-CoV-2 serological tests shows significant variability in performance across different years of infection and between the tests 对严重急性呼吸系统综合征冠状病毒2型血清学测试的比较评估显示,不同感染年份和测试之间的表现存在显著差异
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-10-10 DOI: 10.1016/j.jcvp.2023.100168
Dell-Dylan Kenfack , Georges Nguefack-Tsague , Veronique B Penlap , Martin F Maidadi , Celestin Godwe , Nico F Njayou , Jude D Bigoga , Francine Ntoumi , Eitel Mpoudi-Ngole , Marcel Tongo

Introduction

While the global COVID-19 pandemic is slowly coming under control, current efforts are focused on understanding the epidemiology of endemic SARS-CoV-2. The tool of choice for doing so remains serological tests that detect SARS-CoV-2 induced antibodies. However, the performance of these tests should be evaluated to ensure they comply with the specific performance criteria desired by each country that they are used in.

Methods

Here, we use pre-COVID-19 plasma and plasma from SARS-CoV-2-infected individuals collected in 2020, 2021 and 2022 to evaluate the performance of two commercial Rapid Lateral Flow (RLF) tests (the PANBIO™ COVID-19 IgG/IgM rapid test and the LABNOVATION™ COVID-19 (SARS-CoV-2) IgG/IgM rapid test) and one commercial ELISA test (the PLATELIA™ SARS-CoV-2 total Ab).

Results

We find that whereas the specificity of the two RLF tests is ≥ 95%, it was 91% for the ELISA tests. However, at 14 days post-COVID-19 date of diagnosis (DoD), only the ELISA test constantly achieved a sensitivity of ≥80% over all the three years. In addition, the rate of detection of the two RLF tests varied across the years with a sensitivity ranging from <80% in 2021 to >80% in 2022. More importantly the capacity of these two RLF tests to detect IgG antibodies decreased with time. On the contrary, the sensitivity of the ELISA test was still above 80% more than six months post DoD.

Conclusion

We recommend that sero-epidemiological surveys focused on testing antibodies should not rely on performances reported by the assay manufacturers. They should include a formal evaluation of the selected assays to ensure its limitations and strengths conform with the data-accuracy requirements of the surveys.

简介虽然全球新冠肺炎大流行正在慢慢得到控制,但目前的工作重点是了解地方性SARS-CoV-2的流行病学。选择的工具仍然是检测严重急性呼吸系统综合征冠状病毒2型诱导抗体的血清学测试。然而,应评估这些测试的性能,以确保它们符合每个国家所需的具体性能标准。方法在这里,我们使用2020年、2021年和2022年收集的COVID-19前血浆和SARS-CoV-2感染者的血浆来评估两种商业快速侧流(RLF)测试(PANBIO™ 新冠肺炎IgG/IgM快速检测及实验室™ 新冠肺炎(SARS-CoV-2)IgG/IgM快速检测)和一种商业ELISA检测(PLATELIA™ 结果两种RLF检测的特异性均≥95%,而ELISA检测则为91%。然而,在COVID-19诊断日(DoD)后14天,只有ELISA检测在所有三年中始终达到≥80%的灵敏度。此外,两种RLF测试的检测率在多年内变化,灵敏度范围从<;2021年的80%至>;2022年达到80%。更重要的是,这两种RLF检测IgG抗体的能力随着时间的推移而降低。相反,在DoD后的六个多月里,ELISA检测的灵敏度仍高于80%。结论我们建议专注于检测抗体的血清流行病学调查不应依赖于检测制造商报告的表现。它们应包括对所选分析的正式评估,以确保其局限性和强度符合调查的数据准确性要求。
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引用次数: 0
Viral load in symptomatic and asymptomatic patients infected with SARS-CoV-2. What have we learned? 严重急性呼吸系统综合征冠状病毒2型有症状和无症状感染者的病毒载量。我们学到了什么?
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-10-05 DOI: 10.1016/j.jcvp.2023.100166
Marina Mozgovoj , Merceder Dieder Graham , Cecilia Ferrufino , Sofia Blanc , Adriana Fernandez Souto , Marcela Pilloff , Maria Jose Dus Santos

Asymptomatic and presymptomatic patients played a critical role in the maintenance and spread of infection during COVID pandemic. However, conflicting views about the infectiousness of asymptomatic patients have been raised.

Identification of asymptomatic cases relies on SARS-CoV-2 genome detection and, in the absence of common epidemiological variables, quantification of viral load (VL) has been proposed as an estimator for SARS-CoV-2 transmission.

Comparison of VLs from symptomatic and asymptomatic patients displayed variable results according to the studied population, the experimental design and the sampling, among other variables.

The aim of this work was to determine VLs in symptomatic and asymptomatic patients at the time of sampling and to retrospectively determine their relationship with severity of disease and other parameters that affected the course of COVID-19, in two towns located in Buenos Aires, Argentina.

Results from our study showed that VLs from symptomatic and asymptomatic patients were significantly different when analyzed globally. In addition, significant differences were found when VLs from each COVID-19 wave were analyzed. In the first wave VLs from asymptomatic patients (log10 8,21 gc/µl) were significantly higher than in symptomatic ones (log10 6,51 gc/µl) while; in the second wave, VLs from asymptomatic patients resulted significantly lower than in symptomatic patients (log10 4,51 gc/µl and log10 5,23 gc/µl, respectively). In the third wave, no significant differences were observed between VLs from both types of patients.

Results from this work demonstrated that the screening of both symptomatic and asymptomatic patients was of utmost importance in order to reduce SARS-CoV-2 transmission to communities.

在新冠肺炎大流行期间,无症状和症状前患者在维持和传播感染方面发挥了关键作用。然而,关于无症状患者的传染性,人们提出了相互矛盾的观点。无症状病例的识别依赖于严重急性呼吸系统综合征冠状病毒2型的基因组检测,并且在缺乏常见流行病学变量的情况下,病毒载量(VL)的量化已被提议作为严重急性呼吸系冠状病毒2型传播的估计器。根据研究人群、实验设计和采样等变量,对有症状和无症状患者的VL进行比较显示出不同的结果。这项工作的目的是确定采样时有症状和无症状患者的VL,并回顾性地确定它们与疾病严重程度和影响新冠肺炎进程的其他参数的关系,这两个城镇位于布宜诺斯艾利斯,阿根廷。我们的研究结果表明,在全球范围内分析有症状和无症状患者的VL有显著差异。此外,当分析每个新冠肺炎波的VL时,发现了显著差异。在第一波中,无症状患者的VL(log10 8,21 gc/µl)显著高于有症状患者(log10 6,51 gc/µl),而;在第二波中,无症状患者的VLs显著低于有症状患者(分别为log10 4,51 gc/µl和log10 5,23 gc/µl)。在第三波中,两种类型患者的VL之间没有观察到显著差异。这项工作的结果表明,对有症状和无症状患者的筛查对于减少严重急性呼吸系统综合征冠状病毒2型向社区的传播至关重要。
{"title":"Viral load in symptomatic and asymptomatic patients infected with SARS-CoV-2. What have we learned?","authors":"Marina Mozgovoj ,&nbsp;Merceder Dieder Graham ,&nbsp;Cecilia Ferrufino ,&nbsp;Sofia Blanc ,&nbsp;Adriana Fernandez Souto ,&nbsp;Marcela Pilloff ,&nbsp;Maria Jose Dus Santos","doi":"10.1016/j.jcvp.2023.100166","DOIUrl":"https://doi.org/10.1016/j.jcvp.2023.100166","url":null,"abstract":"<div><p>Asymptomatic and presymptomatic patients played a critical role in the maintenance and spread of infection during COVID pandemic. However, conflicting views about the infectiousness of asymptomatic patients have been raised.</p><p>Identification of asymptomatic cases relies on SARS-CoV-2 genome detection and, in the absence of common epidemiological variables, quantification of viral load (VL) has been proposed as an estimator for SARS-CoV-2 transmission.</p><p>Comparison of VLs from symptomatic and asymptomatic patients displayed variable results according to the studied population, the experimental design and the sampling, among other variables.</p><p>The aim of this work was to determine VLs in symptomatic and asymptomatic patients at the time of sampling and to retrospectively determine their relationship with severity of disease and other parameters that affected the course of COVID-19, in two towns located in Buenos Aires, Argentina.</p><p>Results from our study showed that VLs from symptomatic and asymptomatic patients were significantly different when analyzed globally. In addition, significant differences were found when VLs from each COVID-19 wave were analyzed. In the first wave VLs from asymptomatic patients (log10 8,21 gc/µl) were significantly higher than in symptomatic ones (log10 6,51 gc/µl) while; in the second wave, VLs from asymptomatic patients resulted significantly lower than in symptomatic patients (log10 4,51 gc/µl and log10 5,23 gc/µl, respectively). In the third wave, no significant differences were observed between VLs from both types of patients.</p><p>Results from this work demonstrated that the screening of both symptomatic and asymptomatic patients was of utmost importance in order to reduce SARS-CoV-2 transmission to communities.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 4","pages":"Article 100166"},"PeriodicalIF":1.7,"publicationDate":"2023-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50189706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Post-infectious neurological complications of COVID-19 – A tertiary care center experience 新冠肺炎感染后神经并发症——三级护理中心的经验
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-09-18 DOI: 10.1016/j.jcvp.2023.100165
S.M. Krishna Mohan M , Asish Vijayaraghavan , Soumya Sundaram , Sruthi S. Nair , Sajith Sukumaran

Background

The neurological manifestations of acute SARS-CoV-2 infection are well established, but limited understanding of the post-infectious neurological complications of COVID-19 (PINCC) contributes to significant morbidity and mortality. Hence in this study, we aimed to describe the clinical, radiological, and electrophysiological spectrum and outcome of PINCC from a tertiary referral center.

Methods

We identified 18 cases with diverse neurological manifestations following recovery from an acute SARS-CoV-2 infection. The neurological manifestations, magnetic resonance imaging findings of the brain and spinal cord, nerve conduction studies, and the treatment and outcome data were collected from electronic medical records.

Results

The mean age of presentation was 47± 18.5 years, and 11 patients (61 %) were male. For 11 (61 %) patients, prior COVID-19 symptoms were minimal or absent. The mean time to onset of neurological manifestations was 3 weeks after COVID-19 infection (range 1–8 weeks). 14 patients (77.8 %) had central nervous system (CNS) manifestations, and 4 (22.2 %) had peripheral nervous system (PNS) manifestations. The CNS manifestations included cerebrovascular events in 7, demyelination in 4, and aseptic meningitis, amnestic mild cognitive impairment, and disseminated tuberculosis in one case each. PNS manifestations were Guillain-Barré syndrome, mononeuritis multiplex, asymmetric polyradiculoneuropathy, and isolated diaphragm palsy in one patient each.

Conclusion

Post-infectious neurological complications of COVID-19 can involve both central and peripheral nervous system and is independent of the severity of acute infection.

背景急性SARS-CoV-2感染的神经系统表现已得到很好的证实,但对新冠肺炎(PINCC)感染后神经系统并发症的了解有限,导致了显著的发病率和死亡率。因此,在本研究中,我们旨在描述三级转诊中心PINCC的临床、放射学和电生理学频谱和结果。方法我们确定了18例急性严重急性呼吸系统综合征冠状病毒2型感染康复后具有不同神经系统表现的病例。从电子病历中收集神经系统表现、大脑和脊髓的磁共振成像结果、神经传导研究以及治疗和结果数据。结果患者平均年龄47±18.5岁,11例(61%)为男性。对于11名(61%)患者,既往新冠肺炎症状轻微或不存在。新冠肺炎感染后3周出现神经系统症状的平均时间(范围为1-8周)。14例(77.8%)有中枢神经系统(CNS)表现,4例(22.2%)有外周神经系统(PNS)表现。中枢神经系统表现包括脑血管事件7例,脱髓鞘4例,无菌性脑膜炎、遗忘性轻度认知障碍和播散性肺结核各1例。PNS表现为格林-巴利综合征、多发性单神经炎、不对称多神经根神经病和孤立性膈肌麻痹各1例。结论新冠肺炎感染后神经系统并发症可涉及中枢和外周神经系统,与急性感染的严重程度无关。
{"title":"Post-infectious neurological complications of COVID-19 – A tertiary care center experience","authors":"S.M. Krishna Mohan M ,&nbsp;Asish Vijayaraghavan ,&nbsp;Soumya Sundaram ,&nbsp;Sruthi S. Nair ,&nbsp;Sajith Sukumaran","doi":"10.1016/j.jcvp.2023.100165","DOIUrl":"https://doi.org/10.1016/j.jcvp.2023.100165","url":null,"abstract":"<div><h3>Background</h3><p>The neurological manifestations of acute SARS-CoV-2 infection are well established, but limited understanding of the post-infectious neurological complications of COVID-19 (PINCC) contributes to significant morbidity and mortality. Hence in this study, we aimed to describe the clinical, radiological, and electrophysiological spectrum and outcome of PINCC from a tertiary referral center.</p></div><div><h3>Methods</h3><p>We identified 18 cases with diverse neurological manifestations following recovery from an acute SARS-CoV-2 infection. The neurological manifestations, magnetic resonance imaging findings of the brain and spinal cord, nerve conduction studies, and the treatment and outcome data were collected from electronic medical records.</p></div><div><h3>Results</h3><p>The mean age of presentation was 47± 18.5 years, and 11 patients (61 %) were male. For 11 (61 %) patients, prior COVID-19 symptoms were minimal or absent. The mean time to onset of neurological manifestations was 3 weeks after COVID-19 infection (range 1–8 weeks). 14 patients (77.8 %) had central nervous system (CNS) manifestations, and 4 (22.2 %) had peripheral nervous system (PNS) manifestations. The CNS manifestations included cerebrovascular events in 7, demyelination in 4, and aseptic meningitis, amnestic mild cognitive impairment, and disseminated tuberculosis in one case each. PNS manifestations were Guillain-Barré syndrome, mononeuritis multiplex, asymmetric polyradiculoneuropathy, and isolated diaphragm palsy in one patient each.</p></div><div><h3>Conclusion</h3><p>Post-infectious neurological complications of COVID-19 can involve both central and peripheral nervous system and is independent of the severity of acute infection.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 4","pages":"Article 100165"},"PeriodicalIF":1.7,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"50189707","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exposure factors associated with SARS-CoV-2 seropositivity are not predictive for higher humoral immune responses: A cross-sectional cohort study in the general population 与SARS-CoV-2血清阳性相关的暴露因素不能预测更高的体液免疫反应:一项针对普通人群的横断面队列研究
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-09-03 DOI: 10.1016/j.jcvp.2023.100164
D.A.T. Hanssen , D.M.E. Pagen , J. Penders , S. Brinkhues , N.H.T.M. Dukers-Muijrers , C.J.P.A. Hoebe , P.H.M. Savelkoul , I.H.M. van Loo

Introduction

Higher antibody levels, in particular antibodies directed against the receptor-binding domain (RBD) of the spike protein, protect against re-infection with SARS-CoV-2. Quantitative antibody response data provide insight into population immunity and are essential for decision-making on booster-vaccination strategies. We aimed to identify predictors for higher antibody responses such as gender, age, experienced COVID-19-compatible symptoms, disease severity and exposure to pre-determined risk factors associated with SARS-CoV-2 seropositivity.

Materials and methods

Quantitative anti-S-RBD responses were analysed in seropositive vaccine-naive individuals (n = 1,857) from a study population of 10,001 adults, including healthcare workers (n = 211) and individuals with a known date of a positive PCR (n = 214). Regression models tested associations between age, gender, the period of symptoms, disease severity, pre-identified exposure factors associated with SARS-CoV-2 seropositivity, and anti-S-RBD responses.

Results

Symptoms of more severe disease (fever and/or dyspnoea: OR 2.42 [95%CI 1.76–3.34], and hospital admission: OR 11.41 [95%CI 4.66–27.97]), and a longer interval between COVID-19-compatible symptoms and serum collection (OR 3.17 [95%CI 1.32–7.63]) were predictive for anti-S-RBD levels ≥300 U/mL. Working in healthcare was inversely associated with anti-S-RBD levels ≥300 U/mL (OR 0.51 [95%CI 0.31–0.82]). None of the pre-identified exposure factors associated with SARS-CoV-2 seropositivity could be identified as predictive of higher anti-S-RBD responses.

Conclusion

No exposure factors were identified as predictors of higher neutralising antibody responses. Nevertheless, higher neutralising antibody levels in individuals with more severe symptoms suggest better immunological protection against SARS-CoV-2 re-infection. In seroprevalence studies, that mainly include asymptomatic or mildly infected individuals, the determination of quantitative antibody responses may help in the interpretation of population immunity.

引言更高的抗体水平,特别是针对刺突蛋白受体结合域(RBD)的抗体,可以防止严重急性呼吸系统综合征冠状病毒2型的再次感染。定量抗体反应数据提供了对群体免疫的深入了解,对加强针接种策略的决策至关重要。我们旨在确定更高抗体反应的预测因素,如性别、年龄、经历的COVID-19兼容症状、疾病严重程度以及接触与SARS-CoV-2血清阳性相关的预先确定的风险因素。材料和方法从10001名成年人的研究人群中分析了血清阳性疫苗初始个体(n=1857)的定量抗S-RBD反应,包括医护人员(n=211)和已知PCR阳性日期的个体(n=214)。回归模型测试了年龄、性别、症状时期、疾病严重程度、与严重急性呼吸系统综合征冠状病毒2型血清阳性相关的预先确定的暴露因素和抗S-RBD反应之间的相关性。结果更严重疾病的症状(发烧和/或呼吸困难:or 2.42[95%CI 1.76–3.34],入院:or 11.41[95%CI 4.66–27.97]),以及COVID-19相容性症状与血清采集之间的较长间隔(or 3.17[95%CI 1.32–7.63])可预测抗S-RBD水平≥300 U/mL。在医疗保健部门工作与抗S-RBD水平≥300 U/mL呈负相关(OR 0.51[95%CI 0.31–0.82])。与严重急性呼吸系统综合征冠状病毒2型血清阳性相关的预先确定的暴露因素都不能预测更高的抗S-RBD反应。结论没有暴露因素被确定为较高中和抗体反应的预测因素。然而,症状更严重的人的中和抗体水平更高,表明对严重急性呼吸系统综合征冠状病毒2型再次感染有更好的免疫保护作用。在血清流行率研究中,主要包括无症状或轻度感染者,确定定量抗体反应可能有助于解释群体免疫。
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引用次数: 0
High SARS-CoV-2 seroprevalence in Lagos, Nigeria with robust antibody and cellular immune responses 尼日利亚拉各斯严重急性呼吸系统综合征冠状病毒2型血清流行率高,抗体和细胞免疫反应强
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-08-01 DOI: 10.1016/j.jcvp.2023.100156
Sulaimon Akanmu , Bobby Brooke Herrera , Beth Chaplin , Sade Ogunsola , Akin Osibogun , Fatima Onawoga , Sarah John-Olabode , Iorhen E. Akase , Augustina Nwosu , Donald J. Hamel , Charlotte A. Chang , Phyllis J. Kanki

Background

Early evidence suggested that the impact of the COVID-19 pandemic was less severe in Africa compared to other parts of the world. However, more recent studies indicate higher SARS-CoV-2 infection and COVID-19 mortality rates on the continent than previously documented. Research is needed to better understand SARS-CoV-2 infection and immunity in Africa.

Methods

In early 2021, we studied the immune responses in healthcare workers (HCWs) at Lagos University Teaching Hospital (n = 134) and Oxford-AstraZeneca COVID-19 vaccine recipients from the general population (n = 116) across five local government areas (LGAs) in Lagos State, Nigeria. Western blots were used to simultaneously detect SARS-CoV-2 spike and nucleocapsid (N) antibodies (n = 250), and stimulation of peripheral blood mononuclear cells with N followed by an IFN-γ ELISA was used to examine T cell responses (n = 114).

Results

Antibody data demonstrated high SARS-CoV-2 seroprevalence of 72·4% (97/134) in HCWs and 60·3% (70/116) in the general population. Antibodies directed to only SARS-CoV-2 N, suggesting pre-existing coronavirus immunity, were seen in 9·7% (13/134) of HCWs and 15·5% (18/116) of the general population. T cell responses against SARS-CoV-2 N (n = 114) were robust in detecting exposure to the virus, demonstrating 87·5% sensitivity and 92·9% specificity in a subset of control samples tested. T cell responses against SARS-CoV-2 N were also observed in 83.3% of individuals with N-only antibodies, further suggesting that prior non-SARS-CoV-2 coronavirus infection may provide cellular immunity to SARS-CoV-2.

Conclusions

These results have important implications for understanding the paradoxically high SARS-CoV-2 infection with low mortality rate in Africa and supports the need to better understand the implications of SARS-CoV-2 cellular immunity.

背景早期证据表明,与世界其他地区相比,新冠肺炎大流行在非洲的影响没有那么严重。然而,最近的研究表明,该大陆的SARS-CoV-2感染率和新冠肺炎死亡率高于先前的记录。需要进行研究以更好地了解非洲的SARS-CoV-2感染和免疫。方法2021年初,我们研究了尼日利亚拉各斯州五个地方政府地区(LGA)普通人群(n=116)中拉各斯大学教学医院(n=134)和牛津-阿斯特拉利康新冠肺炎疫苗接种者的医护人员(HCW)的免疫反应。Western印迹法同时检测严重急性呼吸系统综合征冠状病毒2型刺突和核衣壳(N)抗体(N=250),用N刺激外周血单核细胞,然后用IFN-γELISA检测T细胞反应(N=114)。仅针对严重急性呼吸系统综合征冠状病毒2型N的抗体表明已有冠状病毒免疫力,在9.7%(13/134)的HCW和15.0%(18/116)的普通人群中发现。针对严重急性呼吸系统综合征冠状病毒2型N(N=114)的T细胞反应在检测病毒暴露方面是稳健的,在测试的对照样本子集中显示出87.5%的敏感性和92.9%的特异性。在83.3%的具有纯N抗体的个体中也观察到针对严重急性呼吸系统综合征冠状病毒2型N的T细胞应答,进一步表明先前的非严重急性呼吸系统综合征冠状病毒2型感染可能提供对严重急性呼吸综合征冠状病毒的细胞免疫。
{"title":"High SARS-CoV-2 seroprevalence in Lagos, Nigeria with robust antibody and cellular immune responses","authors":"Sulaimon Akanmu ,&nbsp;Bobby Brooke Herrera ,&nbsp;Beth Chaplin ,&nbsp;Sade Ogunsola ,&nbsp;Akin Osibogun ,&nbsp;Fatima Onawoga ,&nbsp;Sarah John-Olabode ,&nbsp;Iorhen E. Akase ,&nbsp;Augustina Nwosu ,&nbsp;Donald J. Hamel ,&nbsp;Charlotte A. Chang ,&nbsp;Phyllis J. Kanki","doi":"10.1016/j.jcvp.2023.100156","DOIUrl":"10.1016/j.jcvp.2023.100156","url":null,"abstract":"<div><h3>Background</h3><p>Early evidence suggested that the impact of the COVID-19 pandemic was less severe in Africa compared to other parts of the world. However, more recent studies indicate higher SARS-CoV-2 infection and COVID-19 mortality rates on the continent than previously documented. Research is needed to better understand SARS-CoV-2 infection and immunity in Africa.</p></div><div><h3>Methods</h3><p>In early 2021, we studied the immune responses in healthcare workers (HCWs) at Lagos University Teaching Hospital (<em>n</em> = 134) and Oxford-AstraZeneca COVID-19 vaccine recipients from the general population (<em>n</em> = 116) across five local government areas (LGAs) in Lagos State, Nigeria. Western blots were used to simultaneously detect SARS-CoV-2 spike and nucleocapsid (N) antibodies (<em>n</em> = 250), and stimulation of peripheral blood mononuclear cells with N followed by an IFN-γ ELISA was used to examine T cell responses (<em>n</em> = 114).</p></div><div><h3>Results</h3><p>Antibody data demonstrated high SARS-CoV-2 seroprevalence of 72·4% (97/134) in HCWs and 60·3% (70/116) in the general population. Antibodies directed to only SARS-CoV-2 N, suggesting pre-existing coronavirus immunity, were seen in 9·7% (13/134) of HCWs and 15·5% (18/116) of the general population. T cell responses against SARS-CoV-2 N (<em>n</em> = 114) were robust in detecting exposure to the virus, demonstrating 87·5% sensitivity and 92·9% specificity in a subset of control samples tested. T cell responses against SARS-CoV-2 N were also observed in 83.3% of individuals with N-only antibodies, further suggesting that prior non-SARS-CoV-2 coronavirus infection may provide cellular immunity to SARS-CoV-2.</p></div><div><h3>Conclusions</h3><p>These results have important implications for understanding the paradoxically high SARS-CoV-2 infection with low mortality rate in Africa and supports the need to better understand the implications of SARS-CoV-2 cellular immunity.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 3","pages":"Article 100156"},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10289822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9736525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Performance of self-collected saliva samples for SARS-CoV-2 mass testing in community settings 社区环境中自采唾液样本在SARS-CoV-2大规模检测中的应用
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-08-01 DOI: 10.1016/j.jcvp.2023.100161
Olivia Kay , Matthias E Futschik , Elena Turek , David Chapman , Simon Carr , Malur Sudhanva , Paul E. Klapper , Tony Cox , Michael Hill , Joanna Cole-Hamilton , Peter Marks , Sarah A Tunkel , Timothy Peto , Lindsey Davies , Tom Fowler

Background

Saliva has been considered a suitable sample material for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA testing, but uncertainty remained regarding sensitivity and reliability of different saliva collection methods.

Objectives

This study aimed to investigate the potential utility of expectorated saliva (ES) and drooled saliva (DS) for community mass testing.

Study design

Self-collected ES and DS samples were obtained in a prospective cohort study with 2,878 participants. The utility of saliva for SARS-CoV-2 qRT-PCR testing was assessed by comparing the capacity to detect SARS-CoV-2 positive cases with results for self-collected combined throat and nose (CTN) swabs. Additionally, quantification cycle (Cq) values were compared.

Results

ES- and DS-based tests showed the same high level of concordance (98% vs 98%) with CTN swab-based results. Sensitivity was higher for DS (94%) than for ES (83%) or CTN swab (90%) but differences were statistically not significant. Comparing only symptomatic cases, however, a significantly higher sensitivity of DS (96%) than of ES (76%) or CTN swab (91%) was observed. Cq values of saliva and swab specimen were significantly correlated and appeared to be not impacted by age or other potentially confounding factors.

Conclusions

Saliva-based SARS-CoV-2 RNA testing showed high diagnostic accuracy and can be considered an alternative where swabbing may not be tolerated or operationally feasible. DS yielded the same or better diagnostic performance compared to ES and may present a preferred option with reduced aerosol risk and increased compliance.

背景唾液一直被认为是严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)RNA检测的合适样本材料,但不同唾液采集方法的敏感性和可靠性仍存在不确定性。目的本研究旨在探讨吐口水(ES)和流口水(DS)在社区大规模检测中的潜在效用。研究设计自采ES和DS样本是在一项有2878名参与者的前瞻性队列研究中获得的。唾液用于严重急性呼吸系统综合征冠状病毒2型qRT-PCR检测的效用是通过比较检测严重急性呼吸系冠状病毒2型阳性病例的能力和自行收集的咽鼻联合拭子(CTN)的结果来评估的。此外,还比较了定量周期(Cq)值。结果基于ES和DS的测试显示出与基于CTN拭子的结果相同的高度一致性(98%对98%)。DS(94%)的敏感性高于ES(83%)或CTN拭子(90%),但差异无统计学意义。然而,仅比较有症状的病例,观察到DS(96%)的敏感性明显高于ES(76%)或CTN拭子(91%)。唾液和拭子样本的Cq值显著相关,似乎不受年龄或其他潜在混杂因素的影响。结论基于唾液的严重急性呼吸系统综合征冠状病毒2型RNA检测显示出较高的诊断准确性,可以被认为是一种替代方法,在这种情况下,拭子可能不耐受或操作不可行。与ES相比,DS具有相同或更好的诊断性能,并且可能是降低气溶胶风险和提高依从性的首选方案。
{"title":"Performance of self-collected saliva samples for SARS-CoV-2 mass testing in community settings","authors":"Olivia Kay ,&nbsp;Matthias E Futschik ,&nbsp;Elena Turek ,&nbsp;David Chapman ,&nbsp;Simon Carr ,&nbsp;Malur Sudhanva ,&nbsp;Paul E. Klapper ,&nbsp;Tony Cox ,&nbsp;Michael Hill ,&nbsp;Joanna Cole-Hamilton ,&nbsp;Peter Marks ,&nbsp;Sarah A Tunkel ,&nbsp;Timothy Peto ,&nbsp;Lindsey Davies ,&nbsp;Tom Fowler","doi":"10.1016/j.jcvp.2023.100161","DOIUrl":"10.1016/j.jcvp.2023.100161","url":null,"abstract":"<div><h3>Background</h3><p>Saliva has been considered a suitable sample material for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA testing, but uncertainty remained regarding sensitivity and reliability of different saliva collection methods.</p></div><div><h3>Objectives</h3><p>This study aimed to investigate the potential utility of expectorated saliva (ES) and drooled saliva (DS) for community mass testing.</p></div><div><h3>Study design</h3><p>Self-collected ES and DS samples were obtained in a prospective cohort study with 2,878 participants. The utility of saliva for SARS-CoV-2 qRT-PCR testing was assessed by comparing the capacity to detect SARS-CoV-2 positive cases with results for self-collected combined throat and nose (CTN) swabs. Additionally, quantification cycle (Cq) values were compared.</p></div><div><h3>Results</h3><p>ES- and DS-based tests showed the same high level of concordance (98% vs 98%) with CTN swab-based results. Sensitivity was higher for DS (94%) than for ES (83%) or CTN swab (90%) but differences were statistically not significant. Comparing only symptomatic cases, however, a significantly higher sensitivity of DS (96%) than of ES (76%) or CTN swab (91%) was observed. Cq values of saliva and swab specimen were significantly correlated and appeared to be not impacted by age or other potentially confounding factors.</p></div><div><h3>Conclusions</h3><p>Saliva-based SARS-CoV-2 RNA testing showed high diagnostic accuracy and can be considered an alternative where swabbing may not be tolerated or operationally feasible. DS yielded the same or better diagnostic performance compared to ES and may present a preferred option with reduced aerosol risk and increased compliance.</p></div>","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 3","pages":"Article 100161"},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41584615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
High concordance of the TaqMan SARS-CoV-2 mutation panel and spike gene sequencing for the detection of SARS-COV-2 Variants Of Concern TaqMan SARS-CoV-2突变面板与刺突基因测序高度一致,用于检测关注的SARS-CoV-2变异
IF 1.7 Q4 INFECTIOUS DISEASES Pub Date : 2023-08-01 DOI: 10.1016/j.jcvp.2023.100159
Paul Alain Tagnouokam-Ngoupo , Chavely Gwladys Monamele , Serge Alain Sadeuh-Mba , Jules Brice Tchatchueng-Mbougua , Estelle Madaha Longla , Ngu Njei Abanda , Vanessa Ilouga , Moise Henri Moumbeket Yifomnjou , Mathurin Cyrille Tejiokem , Sara Eyangoh , Richard Njouom
{"title":"High concordance of the TaqMan SARS-CoV-2 mutation panel and spike gene sequencing for the detection of SARS-COV-2 Variants Of Concern","authors":"Paul Alain Tagnouokam-Ngoupo ,&nbsp;Chavely Gwladys Monamele ,&nbsp;Serge Alain Sadeuh-Mba ,&nbsp;Jules Brice Tchatchueng-Mbougua ,&nbsp;Estelle Madaha Longla ,&nbsp;Ngu Njei Abanda ,&nbsp;Vanessa Ilouga ,&nbsp;Moise Henri Moumbeket Yifomnjou ,&nbsp;Mathurin Cyrille Tejiokem ,&nbsp;Sara Eyangoh ,&nbsp;Richard Njouom","doi":"10.1016/j.jcvp.2023.100159","DOIUrl":"10.1016/j.jcvp.2023.100159","url":null,"abstract":"","PeriodicalId":73673,"journal":{"name":"Journal of clinical virology plus","volume":"3 3","pages":"Article 100159"},"PeriodicalIF":1.7,"publicationDate":"2023-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46878198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Journal of clinical virology plus
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