antibody testing

  • 文章类型: Journal Article
    雅芳父母和子女纵向研究(ALSPAC)是一项基于人群的前瞻性队列研究,该研究在1990-1992年招募了孕妇,并跟踪了这些妇女,从那时起,他们的伴侣(第0代;G0代)和他们的后代(第1代;G1代)。这项研究对2019年冠状病毒病(COVID-19)大流行反应迅速,3月份部署了三份在线问卷,2020年5月和10月。基于家庭的抗体测试伴随着第三份问卷。此外,与英国公共卫生(PHE)支柱I和II的联系已经获得了所有同意的参与者或我们有NHS保密批准小组允许进入第251节的参与者的测试结果.为了进行研究,我们从现有数据中确定了可能的COVID-19病例。为了确定可能的情况,我们根据数据的来源制定了一个层次结构:自我报告,抗体测试结果和支柱I和II连接及其组合;提供病例状态的更多确定性。本数据说明描述了我们如何在ALSPAC中确定病例状态。随后的病例变量将通过我们的COVID发布文件以及PHE的测试数据提供。
    The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective population-based cohort study which recruited pregnant women in 1990-1992 and has followed these women, their partners (Generation 0; G0) and their offspring (Generation 1; G1) ever since. The study reacted rapidly to the coronavirus disease 2019 (COVID-19) pandemic, deploying three online questionnaires in March, May and October 2020. Home-based antibody tests accompanied the third questionnaire. In addition, linkage to Public Health England (PHE) Pillar I and II testing results has been obtained for all participants who have consented or for whom we have NHS Confidentiality approval group permitted Section 251 access. For the purposes of ongoing study, we have identified likely cases of COVID-19 from available data. To determine likely cases, we have developed a hierarchy depending on the source of the data: self-report, antibody test result and Pillar I and II linkage and a combination thereof; providing more certainty in the case status. This data note describes how we have ascertained case status in ALSPAC. The subsequent case variable will be made available through our COVID release files alongside testing data from PHE.
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  • 文章类型: Journal Article
    背景:获得SARS-CoV-2检测的机会有限已被确定为医护人员(HCWs)焦虑的潜在来源,但重复检测对儿科HCWs中与大流行相关的焦虑的影响尚未被研究.我们试图了解反复进行SARS-CoV-2抗体测试对小儿HCWs的COVID-19焦虑的影响。方法:这项纵向队列研究于2020年4月至7月进行。参与者,362儿科HCWs,每96小时或每周进行一次SARS-CoV-2抗体快速检测,并要求以视觉模拟量表对他们的COVID-19焦虑进行评分。计算每个测试日反应的自我报告焦虑相对于研究基线的变化。双变量分析,重复的措施,和logistic回归分析用于检查与焦虑变化相关的人口统计学。结果:基线COVID-19焦虑在经验少于10年的医护人员中明显更高(Z=−2.63,p=0.009),与男性相比,女性(Z=−3.66p<0.001),与其他医护人员相比(F(3,302)=6.04,p=0.003)。排除测试结果为阳性的参与者后,重复测量分析表明,焦虑随着时间的推移而减少(F(5,835)=3.14,p=0.008)。在报告焦虑减少的医护人员中,57(29.8%)有临床意义的下降(≥30%),急诊科(ED)HCWs报告有临床意义的焦虑下降的可能性是1.97倍(X2(1)=5.05,p=0.025)。结论:结果表明,反复进行SARS-CoV-2抗体血清学检测与HCWs中COVID-19焦虑降低有关。常规筛查该疾病可能是减轻儿科HCWs大流行相关焦虑的有用策略。
    Background: Limited access to SARS-CoV-2 testing has been identified as a potential source of anxiety among healthcare workers (HCWs), but the impact of repeated testing on pandemic-related anxiety in pediatric HCWs has not been examined. We sought to understand the impact of repeated SARS-CoV-2 antibody testing on pediatric HCWs’ COVID-19 anxiety. Methods: This longitudinal cohort study was conducted between April and July 2020. Participants, 362 pediatric HCWs, underwent rapid SARS-CoV-2 antibody testing either every 96 h or weekly and were asked to rate their COVID-19 anxiety on a visual analog scale. Changes in self-reported anxiety from the study baseline were calculated for each testing day response. Bivariate analyses, repeated measures, and logistic regression analyses were performed to examine demographics associated with changes in anxiety. Results: Baseline COVID-19 anxiety was significantly higher in HCWs with less than 10 years of experience (Z = −2.63, p = 0.009), in females compared to males (Z = −3.66 p < 0.001), and in nurses compared to other HCWs (F (3,302) = 6.04, p = 0.003). After excluding participants who received a positive test result, repeated measures analyses indicated that anxiety decreased over time (F (5,835) = 3.14, p = 0.008). Of the HCWs who reported decreased anxiety, 57 (29.8%) had a clinically meaningful decrease (≥30%) and Emergency Department (ED) HCWs were 1.97 times more likely to report a clinically meaningful decrease in anxiety (X2 (1) = 5.05, p = 0.025). Conclusions: The results suggest that repeated SARS-CoV-2 antibody serology testing is associated with decreased COVID-19 anxiety in HCWs. Routine screening for the disease may be a helpful strategy in attenuating pandemic-related anxiety in pediatric HCWs.
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  • 文章类型: Clinical Trial, Phase IV
    继发性免疫缺陷的个体属于最容易屈服于COVID-19的群体,因此优先考虑接种SARS-CoV-2疫苗。然而,在这些患者中,关于SARS-CoV-2-mRNA疫苗接种后的持续性和记忆记忆反应的知识有限.
    在未来,开放标签,四期试验我们分析了S1特异性IgG,先前未感染的癌症或自身免疫性疾病患者在初次mRNA疫苗接种期间和加强后长达一个月的中和抗体和细胞因子反应。
    263例实体瘤患者(SOT,n=63),多发性骨髓瘤(MM,n=70),炎症性肠病(IBD,n=130)和66个对照进行了分析。在两剂量初次疫苗接种后一个月,最高的无应答率与较低的CD19B细胞计数相关,并且在MM患者中发现(17%)。在对照组和IBD患者中,S1特异性IgG水平与IL-2和IFN-γ反应相关,但不是在癌症患者身上。第二次给药六个月后,18%的MM患者,SOT的10%和IBD的4%成为血清阴性;对照组中没有人成为阴性。然而,在用TNF-α抑制剂治疗的IBD患者中,抗体水平比对照组下降得更快.总的来说,用mRNA-1273接种导致比BNT162b2更高的抗体水平。重要的是,在血清反应者中,加强疫苗接种可使抗体水平增加>8倍,即使在无法检测到加强前抗体水平的患者中,也可诱导记忆记忆反应.然而,即使在加强疫苗接种后,使用TNF-α抑制剂的IBD患者中,抗体水平低于未治疗IBD患者和对照组.
    疫苗特异性抗体和细胞反应的免疫监测似乎有助于确定疫苗接种失败,从而建立个性化的疫苗接种时间表。包括较短的助推器间隔,并有助于提高所有继发性免疫缺陷患者的疫苗效力。
    EudraCT编号:2021-000291-11。
    Individuals with secondary immunodeficiencies belong to the most vulnerable groups to succumb to COVID-19 and thus are prioritized for SARS-CoV-2 vaccination. However, knowledge about the persistence and anamnestic responses following SARS-CoV-2-mRNA vaccinations is limited in these patients.
    In a prospective, open-label, phase four trial we analyzed S1-specific IgG, neutralizing antibodies and cytokine responses in previously non-infected patients with cancer or autoimmune disease during primary mRNA vaccination and up to one month after booster.
    263 patients with solid tumors (SOT, n=63), multiple myeloma (MM, n=70), inflammatory bowel diseases (IBD, n=130) and 66 controls were analyzed. One month after the two-dose primary vaccination the highest non-responder rate was associated with lower CD19+ B-cell counts and was found in MM patients (17%). S1-specific IgG levels correlated with IL-2 and IFN-γ responses in controls and IBD patients, but not in cancer patients. Six months after the second dose, 18% of patients with MM, 10% with SOT and 4% with IBD became seronegative; no one from the control group became negative. However, in IBD patients treated with TNF-α inhibitors, antibody levels declined more rapidly than in controls. Overall, vaccination with mRNA-1273 led to higher antibody levels than with BNT162b2. Importantly, booster vaccination increased antibody levels >8-fold in seroresponders and induced anamnestic responses even in those with undetectable pre-booster antibody levels. Nevertheless, in IBD patients with TNF-α inhibitors even after booster vaccination, antibody levels were lower than in untreated IBD patients and controls.
    Immunomonitoring of vaccine-specific antibody and cellular responses seems advisable to identify vaccination failures and consequently establishing personalized vaccination schedules, including shorter booster intervals, and helps to improve vaccine effectiveness in all patients with secondary immunodeficiencies.
    EudraCT Number: 2021-000291-11.
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  • 文章类型: Journal Article
    雅芳父母和子女纵向研究(ALSPAC)是一个基于人群的前瞻性队列,该队列在1990-1992年招募了孕妇,并跟踪了这些妇女。从那时起,他们的伴侣(第0代;G0代)和他们的后代(第1代;G1代)。这项研究对2019年冠状病毒病(COVID-19)大流行做出了迅速而反复的反应,在2020年10月部署多个在线问卷和之前的基于家庭的抗体测试。第二次抗体测试,与其他十项纵向人口研究合作,在2021年4月至6月间由4,622名ALSPAC参与者完成。在具有有效刺突蛋白抗体测试结果的参与者中(4,241;8.2%的空白),表明对COVID-19疫苗接种或自然感染的抗体反应,3,172为阳性(74.8%)。代际差异很大,2,463/2,555G0参与者分类为阳性(96.4%),而709/1,686G1参与者(42.1%)。在具有有效核衣壳抗体测试结果的参与者中(4,199;9.2%的空白),提示潜在的和最近的自然感染,493名阳性(11.7%);248/2,526名G0参与者(9.8%)和245/1,673名G1参与者(14.6%)检测为阳性,分别。我们还将这一轮测试的结果与2020年10月进行的测试结果进行了比较。未来的工作将将这些测试结果与其他数据源相结合,以确定参与者的COVID-19感染和疫苗接种状况。这些ALSPACCOVID-19血清学数据正在补充与健康记录和英国公共卫生支柱检测结果的联系,除了之前的四次问卷波和之前的抗体测试。数据已经发布,作为对以前COVID-19数据集的更新。这些包括:1)标准数据集,其中包含所有参与者对所有四个先前问卷的反应,并具有关键的社会人口统计学因素;以及2)个体参与者特定的发布文件,从而能够在研究支持的所有领域进行定制研究。该数据说明描述了第二次ALSPAC抗体测试和从中获得的数据。
    The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective population-based cohort which recruited pregnant women in 1990-1992 and has followed these women, their partners (Generation 0; G0) and their offspring (Generation 1; G1) ever since. The study reacted rapidly and repeatedly to the coronavirus disease 2019 (COVID-19) pandemic, deploying multiple online questionnaires and a previous home-based antibody test in October 2020. A second antibody test, in collaboration with ten other longitudinal population studies, was completed by 4,622 ALSPAC participants between April and June 2021. Of 4,241 participants with a valid spike protein antibody test result (8.2% were void), indicating antibody response to either COVID-19 vaccination or natural infection, 3,172 were positive (74.8%). Generational differences were substantial, with 2,463/2,555 G0 participants classified positive (96.4%) compared to 709/1,686 G1 participants (42.1%). Of 4,199 participants with a valid nucleocapsid antibody test result (9.2% were void), suggesting potential and recent natural infection, 493 were positive (11.7%); 248/2,526 G0 participants (9.8%) and 245/1,673 G1 participants (14.6%) tested positive, respectively. We also compare results for this round of testing to that undertaken in October 2020. Future work will combine these test results with additional sources of data to identify participants\' COVID-19 infection and vaccination status. These ALSPAC COVID-19 serology data are being complemented with linkage to health records and Public Health England pillar testing results as they become available, in addition to four previous questionnaire waves and a prior antibody test. Data have been released as an update to the previous COVID-19 datasets. These comprise: 1) a standard dataset containing all participant responses to all four previous questionnaires with key sociodemographic factors; and 2) individual participant-specific release files enabling bespoke research across all areas supported by the study. This data note describes the second ALSPAC antibody test and the data obtained from it.
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  • 文章类型: Journal Article
    医护人员(HCWs)感染SARS-CoV-2的风险增加,然而,并非所有人都面临同样的风险。我们旨在确定智利HCWs的IgG/IgM患病率和与血清阳性相关的危险因素。
    这是一个全国性的,横断面研究,包括问卷调查和COVID-19侧流IgG/IgM抗体检测。在智利的第一波浪潮之后,智利公共卫生保健系统中的所有HCW都被邀请参加。
    85,529例HCWs中的IgG/IgM阳性为7.2%,地区之间从1.6%到12.4%不等。此外,9.7%的HCWs报告PCR阳性,其中47%为血清阳性。总的来说,10,863例(12.7%)HCWs为PCR和/或IgG/IgM阳性。与血清阳性比值比(ORs)增加独立相关的因素是:在医院工作,夜班,与Covid-19联系,使用公共交通工具,男性,年龄>45,BMI≥30,并报告≥2症状。压力和/或心理健康障碍和吸烟与OR降低有关。当在模型中包括PCR阳性病例时,这些因素仍然显著。
    医院中的HCWs患COVID-19的风险最高,并确定了几个血清阳性和/或PCR阳性的独立危险因素。
    Health care workers (HCWs) are at increased risk for SARS-CoV-2 infection, however not all face the same risk. We aimed to determine IgG/IgM prevalence and risk factors associated with seropositivity in Chilean HCWs.
    This was a nationwide, cross-sectional study including a questionnaire and COVID-19 lateral flow IgG/IgM antibody testing. All HCWs in the Chilean public health care system were invited to participate following the country\'s first wave.
    IgG/IgM positivity in 85,529 HCWs was 7.2%, ranging from 1.6% to 12.4% between regions. Additionally, 9.7% HCWs reported a positive PCR of which 47% were seropositive. Overall, 10,863 (12.7%) HCWs were PCR and/or IgG/IgM positive. Factors independently associated with increased odds ratios (ORs) for seropositivity were: working in a hospital, night shifts, contact with Covid-19, using public transport, male gender, age>45, BMI ≥30, and reporting ≥2 symptoms. Stress and/or mental health disorder and smoking were associated with decreased ORs. These factors remained significant when including PCR positive cases in the model.
    HCWs in the hospital were at highest risk for COVID-19, and several independent risk factors for seropositivity and/or PCR positivity were identified.
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  • 文章类型: Journal Article
    背景: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(SARS-CoV-2)的流行病学至关重要。各种技术,包括实验室化验和即时自检,可用于抗体测试。血清阳性率研究的解释需要有关抗体测试性能的比较数据。
    方法:2020年6月,英国警察部队和消防部门的现任和前任成员进行了自检侧流免疫测定(LFIA),有一个护士表演的LFIA,并提供了用于酶联免疫吸附测定(ELISA)的静脉血样品。我们介绍了SARS-CoV-2抗体的流行以及自检LFIA的可接受性和可用性,与实验室ELISA相比,我们确定了LFIA的敏感性和特异性。
    结果:在这个由5189名现任和前任警察和263名消防人员组成的队列中,7.4%(396/5348;95%置信区间[CI],6.7-8.1)抗体阳性。40岁以下人群血清阳性率为8.9%(95%CI,6.9-11.4),非白人种族的11.5%(95%CI,8.8-15.0),在目前工作的人中,有7.8%(95%CI,7.1-8.7)。自检LFIA的可接受性为97.7%,可用性为90.0%。参与者内部LFIA结果之间存在实质性一致性(kappa0.80;95%CI,0.77-0.83)。LFIA具有相似的性能:与ELISA相比,敏感性为82.1%(95%CI,77.7-86.0)和76.4%(95%CI,71.9-80.5),护士进行的特异性为97.8%(95%CI,97.3-98.2)和98.5%(95%CI,98.1-98.8),分别。
    结论:在英格兰第一波发病后,这个非医疗保健关键工作者队列中,有更大比例的人曾有SARS-CoV-2感染的证据,高于普通人群的6.0%(95%CI,5.8-6.1)。参与者报告的高可接受性和可用性以及自我测试和护士执行的LFIA的类似性能表明,自我测试LFIA适合用于职业和社区患病率研究中的家庭测试。
    BACKGROUND: 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.
    METHODS: 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.
    RESULTS: 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.
    CONCLUSIONS: 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.
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  • 文章类型: Journal Article
    The Avon Longitudinal Study of Parents and Children (ALSPAC) is a prospective population-based cohort study which recruited pregnant women in 1990-1992 and has followed these women, their partners (Generation 0; G0) and offspring (Generation 1; G1) ever since. The study reacted rapidly to the COVID-19 pandemic, deploying online questionnaires in March and May 2020. Home-based antibody tests and a further questionnaire were sent to 5220 participants during a two-week period of October 2020. 4.2% (n=201) of participants reported a positive antibody test (3.2% G0s [n=81]; 5.6% G1s [n=120]). 43 reported an invalid test, 7 did not complete and 3 did not report their result. Participants uploaded a photo of their test to enable validation: all positive tests, those where the participant could not interpret the result and a 5% random sample were manually checked against photos. We report 92% agreement (kappa=0.853). Positive tests were compared to additional COVID-19 status information: 58 (1.2%) participants reported a previous positive test, 73 (1.5%) reported that COVID-19 was suspected by a doctor, but not tested and 980 (20.4%) believed they had COVID-19 due to their own suspicions.  Of those reporting a positive result on our antibody test, 55 reported that they did not think they had had COVID-19. Results from antibody testing and questionnaire data will be complemented by health record linkage and results of other biological testing- uniting Pillar testing data with home testing and self-report. Data have been released as an update to the original datasets released in July 2020. It comprises: 1) a standard dataset containing all participant responses to all three questionnaires with key sociodemographic factors and 2) as individual participant-specific release files enabling bespoke research across all areas supported by the study. This data note describes the antibody testing, associated questionnaire and the data obtained from it.
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  • 文章类型: Journal Article
    End-stage renal disease (ESRD) patients receiving haemodialysis (HD) are a vulnerable group of patients with increased mortality from COVID-19. Despite improved understanding, the duration of host immunity following COVID-19 infection and role of serological testing alone or in addition to real-time reverse transcription polymerase chain reaction (rRT-PCR) testing in the HD population is not fully understood, which this study aimed to investigate.
    There were two parts to this study. Between 15th March 2020 to 15th July 2020, patients receiving HD who tested positive on rRT-PCR for SARS-CoV-2 were recruited into the COVID-19 arm, whilst asymptomatic patients without a previous diagnosis of COVID-19 were recruited to the epidemiological arm of the Salford Kidney Study (SKS). All patients underwent monthly testing for anti-SARS-CoV-2 antibodies as per routine clinical practice since August 2020. The aims were twofold: firstly, to determine seroprevalence and COVID-19 exposure in the epidemiological arm; secondly, to assess duration of the antibody response in the COVID-19 arm. Baseline characteristics were reviewed between groups. Statistical analysis was performed using SPSS. Mann-Whitney U and Chi-squared tests were used for testing significance of difference between groups.
    In our total HD population of 411 patients, 32 were PCR-positive for COVID-19. Of the remaining patients, 237 were recruited into the SKS study, of whom 12 (5.1%) had detectable anti-SARS-CoV-2 antibodies. Of the 32 PCR-positive patients, 27 (84.4%) were symptomatic and 25 patients admitted to hospital due to their symptoms. Of the 22 patients in COVID-19 arm that underwent testing for anti-SARS-CoV-2 IgG antibodies beyond 7 months, all had detectable antibodies. A higher proportion of the patients with COVID-19 were frail compared to patients without a diagnosis of COVID-19 (64.3% vs 34.1%, p = 0.003). Other characteristics were similar between the groups. Over a median follow up of 7 months, a higher number of deaths were recorded in patients with a diagnosis of COVID-19 compared to those without (18.7% vs 5.9%, p = 0.003).
    Serological testing in the HD population is a valuable tool to determine seroprevalence, monitor exposure, and guide improvements for infection prevention and control (IPC) measures to help prevent local outbreaks. This study revealed HD patients mount a humoral response detectable until at least 7 months after COVID-19 infection and provides hope of similar protection with the vaccines recently approved.
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  • 文章类型: Journal Article
    在COVID-19大流行期间,一些国家建议抗体检测作为监测病毒传播的监测工具,并有可能放松限制。在英国,抗体检测最初是英国政府COVID-19检测计划的第三大支柱,人们认为抗体检测结果呈阳性的人可以恢复正常生活。然而,当时科学家和公众对COVID-19抗体的寿命知之甚少,以及它们是否对病毒的再感染或传播具有免疫力。
    本文探讨了英国公众对COVID-19检测的理解,感知的测试准确性,阳性测试结果的含义,愿意遵守限制性措施,以回应抗体测试结果,以及他们期望其他人如何回应。
    在线同步焦点小组是在2020年4月/5月的第一波大流行和COVID-19限制性措施最严格的时期进行的。数据进行了主题分析。
    对于那些接受阳性或阴性测试的人是否应该重返工作岗位,以及哪些限制性措施将适用于他们或他们的家庭成员,人们对此感到困惑。参与者对更广泛的公众对阳性抗体测试结果和不良行为影响的反应表示关注。有人担心抗体测试可能会造成一个分裂的社会,特别是如果测试结果为阳性的人获得更大的自由或选择无视限制性措施。
    如果这些测试更广泛地提供,应与公众协商制定信息,以确保测试结果和后续行为的清晰度和不确定性。
    During the COVID-19 pandemic, antibody testing was proposed by several countries as a surveillance tool to monitor the spread of the virus and potentially to ease restrictions. In the UK, antibody testing originally formed the third pillar of the UK Government\'s COVID-19 testing programme and was thought to offer hope that those with a positive antibody test result could return to normal life. However, at that time scientists and the public had little understanding of the longevity of COVID-19 antibodies, and whether they provided immunity to reinfection or transmission of the virus.
    This paper explores the UK public\'s understanding of COVID-19 testing, perceived test accuracy, the meaning of a positive test result, willingness to adhere to restrictive measures in response to an antibody test result and how they expect other people to respond.
    On-line synchronous focus groups were conducted in April/May 2020 during the first wave of the pandemic and the most stringent period of the COVID-19 restrictive measures. Data were analysed thematically.
    There was confusion in responses as to whether those with a positive or negative test should return to work and which restrictive measures would apply to them or their household members. Participants raised concerns about the wider public response to positive antibody test results and the adverse behavioural effects. There were worries that antibody tests could create a divided society particularly if those with a positive test result were given greater freedoms or chose to disregard the restrictive measures.
    Should these tests be offered more widely, information should be developed in consultation with the public to ensure clarity and address uncertainty about test results and subsequent behaviours.
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  • 文章类型: Journal Article
    接受维持性血液透析(MHD)的患者极易感染严重急性呼吸道综合症冠状病毒2(SARS-CoV-2)。本研究旨在根据接受MHD的中国患者的核酸检测(NAT)和抗体检测来评估SARS-CoV-2感染的患病率。
    横断面研究。
    自2019年12月1日至2020年3月31日,武汉市5家大型血液透析中心共1,027名MHD患者,中国,已注册。通过症状和胸部的初始计算机断层扫描(CT)对患者进行SARS-CoV-2感染筛查。如果患者在初次筛查后出现症状为阴性,进行重复CT检查.怀疑感染SARS-CoV-2的患者用2个连续的咽喉拭子检测病毒RNA。2020年3月中旬,对所有MHD患者进行了SARS-CoV-2抗体检测。
    SARS-CoV-2的NAT和抗体检测结果。
    发病率,临床特征,以及实验室和放射学发现。
    使用t检验或Mann-WhitneyU检验检查组间差异,将未感染的患者与受感染的患者进行比较,并将使用NAT检测到的感染患者与血清学检测结果阳性的感染患者进行比较。
    在接受MHD的1,027名患者中,99人被确定患有SARS-CoV-2感染,患病率为9.6%。在99个案例中,最初通过NAT阳性诊断为SARS-CoV-2感染52(53%);后来通过针对SARS-CoV-2的免疫球蛋白G(IgG)或IgM抗体阳性鉴定了47(47%)。在这47例患者中有一系列的抗体谱:5例(11%)的IgM抗体,IgG抗体在35(74%),和IgM和IgG抗体在7(15%)。在99个案例中,51%的患者在流行期间无症状;61%的患者在胸部CT上有毛玻璃影或斑片状影,而未感染患者为11.6%(P<0.001)。高血压肾病患者更常被发现患有SARS-CoV-2感染,并且比其他主要原因导致肾衰竭的患者更有症状。
    NAT和抗体检测可能的假阳性和假阴性结果;可能缺乏对其他透析人群的普适性。
    接受MHD的患者中有一半的SARS-CoV-2感染是亚临床的,未通过胸部的通用CT和选择性NAT进行鉴定。血清学测试可能有助于评估感染SARS-CoV-2的MHD患者的总体患病率并了解临床病程的多样性。
    Patients receiving maintenance hemodialysis (MHD) are highly vulnerable to infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The current study was designed to evaluate the prevalence of SARS-CoV-2 infection based on both nucleic acid testing (NAT) and antibody testing in Chinese patients receiving MHD.
    Cross-sectional study.
    From December 1, 2019, to March 31, 2020, a total of 1,027 MHD patients in 5 large hemodialysis centers in Wuhan, China, were enrolled. Patients were screened for SARS-CoV-2 infection by symptoms and initial computed tomography (CT) of the chest. If patients developed symptoms after the initial screening was negative, repeat CT was performed. Patients suspected of being infected with SARS-CoV-2 were tested with 2 consecutive throat swabs for viral RNA. In mid-March 2020, antibody testing for SARS-CoV-2 was obtained for all MHD patients.
    NAT and antibody testing results for SARS-CoV-2.
    Morbidity, clinical features, and laboratory and radiologic findings.
    Differences between groups were examined using t test or Mann-Whitney U test, comparing those not infected with those infected and comparing those with infection detected using NAT with those with infection detected by positive serology test results.
    Among 1,027 patients receiving MHD, 99 were identified as having SARS-CoV-2 infection, for a prevalence of 9.6%. Among the 99 cases, 52 (53%) were initially diagnosed with SARS-CoV-2 infection by positive NAT; 47 (47%) were identified later by positive immunoglobulin G (IgG) or IgM antibodies against SARS-CoV-2. There was a spectrum of antibody profiles in these 47 patients: IgM antibodies in 5 (11%), IgG antibodies in 35 (74%), and both IgM and IgG antibodies in 7 (15%). Of the 99 cases, 51% were asymptomatic during the epidemic; 61% had ground-glass or patchy opacities on CT of the chest compared with 11.6% among uninfected patients (P<0.001). Patients with hypertensive kidney disease were more often found to have SARS-CoV-2 infection and were more likely to be symptomatic than patients with another primary cause of kidney failure.
    Possible false-positive and false-negative results for both NAT and antibody testing; possible lack of generalizability to other dialysis populations.
    Half the SARS-CoV-2 infections in patients receiving MHD were subclinical and were not identified by universal CT of the chest and selective NAT. Serologic testing may help evaluate the overall prevalence and understand the diversity of clinical courses among patients receiving MHD who are infected with SARS-CoV-2.
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