新型冠状病毒IgM/IgG抗体在病程监测中的临床意义

目的评价新型冠状病毒(SARS-CoV-2)IgM/IgG抗体检测(化学发光法)在新型冠状病毒肺炎(COVID-19)病程监测和转归方面的临床意义。方法回顾性研究。收集2020年1月20日至2020年3月1日在天津市疾病预防控制中心核酸检测阳性的COVID-19确诊患者88例(115例血清样本)作为疾病组,排除COVID-19(核酸检测阴性)的其他疾病患者245例(245例血清样本)作为对照组。用化学发光法检测SARS-CoV-2 IgM和IgG抗体。结果 SARS-CoV-2 IgM抗体检测的敏感性、特异性分别为90.91%、100%;SARS-CoV-2 IgG抗体检测的敏感性、特异性分别为88.64%、100%;IgM和IgG抗体联合检测敏感性显著提高至96.59%,特异性为100%,与核酸检测的总符合率高达99.10%。SARS-CoV-2 IgM抗体水平在COVID-19病程中呈现先升高后降低的趋势,IgG抗体水平随着病程的进展逐渐升高。结论 SARS-CoV-2 IgM和IgG抗体化学发光法联合检测敏感性高,可作为COVID-19一种有效的辅助诊断,在病程监测和转归方面有一定的意义。     

SARS-CoV-2抗体检测在新型冠状病毒肺炎诊断中的应用价值

目的探讨血清严重急性呼吸综合征冠状病毒(SARS-CoV-2)IgM和IgG抗体检测在新型冠状病毒肺炎(COVID-19)诊断中的价值。方法选取COVID-19患者173例(COVID-19组),其中140例SARSCoV-2首次核酸检测阳性,33例多次检测后呈阳性。以101例排除COVID-19的患者作为对照组。采用胶体金免疫层析法(CGIA)检测SARS-CoV-2 IgM和IgG抗体,采用荧光定量聚合酶链反应(PCR)检测SARS-CoV-2核酸。以临床诊断为金标准,分析SARS-CoV-2 IgM和IgG抗体诊断COVID-19的效能。结果 SARS-CoV-2 IgM和IgG抗体的敏感性分别为76.9%、74.6%,特异性分别为94.0%、95.1%,临床总符合率分别为83.2%、82.1%,与临床诊断的一致性均较好(kappa值分别为0.663、0.644)。受试者工作特征(ROC)曲线分析结果显示,SARS-CoV-2 IgM和IgG抗体诊断COVID-19的曲线下面积(AUC)均为0.85。结论 SARS-CoV-2抗体检测具有较高的敏感性、特异性和临床总符合率,可用于COVID-19的辅助诊断。     

胶体金法与ELISA检测新型冠状病毒IgM和IgG抗体的临床诊断价值比较

目的通过胶体金法与酶联免疫吸附测定(ELISA)检测新型冠状病毒(SARS-CoV-2)特异性抗体免疫球蛋白(Ig)M和IgG,评价2种方法在检测SARS-CoV-2特异性抗体中的诊断价值。方法收集2020年1-2月在该院住院的患者81例,根据相关标准分为新型冠状病毒肺炎(COVID-19)确诊患者组38例,疑似患者组43例。采用胶体金法与ELISA检测所有研究对象的SARS-CoV-2 IgM和IgG抗体,计算2种检测方法的灵敏度和特异度。采用χ²检验对疑似患者检测结果进行比较,分析2种检测方法的一致性。结果ELISA检测SARS-CoV-2 IgM和IgG抗体的灵敏度分别为55.26%(21/38)、60.53%(23/38),特异度均为97.67%(42/43);胶体金法检测SARS-CoV-2 IgM和IgG抗体的灵敏度分别为63.16%(24/38)、76.32%(29/38),特异度均为93.02%(40/43)。SARS-CoV-2特异性抗体IgM、IgG联合检测的阳性率均>70%。2种方法检测IgM和IgG抗体结果比较,差异无统计学意义(P>0.05)。结论在COVID-19患者血清抗体检测过程中,胶体金法检测操作简便、快速、费用低,且有较好的特异度,特异性抗体IgM和IgG联合检测可作为核酸检测的补充手段。     

SARS-CoV-2抗体动态监测在COVID-19诊断中的价值

目的探讨严重急性呼吸综合征冠状病毒2(SARS-CoV-2)免疫球蛋白(Ig)M和IgG抗体检测在新型冠状病毒肺炎(COVID-19)诊断中的价值。方法选取COVID-19患者80例,以排除COVID-19的患者20例作为对照组。采用胶体金法检测SARS-CoV-2 IgM抗体和IgG抗体。收集23例COVID-19患者不同时间点采集的样本,并进行SARS-CoV-2抗体检测。结果 SARS-CoV-2 IgM抗体、IgG抗体和IgM+IgG抗体联用的特异性均为100%,敏感性分别为76.3%、81.3%、90.0%,总体符合率分别为81.0%、85.0%、92.0%。在发病7 d内,SARS-CoV-2 IgM抗体、IgG抗体和IgM+IgG抗体联用的敏感性分别为65.0%、70.0%、70.0%;在发病8～14 d,三者的敏感性分别为72.7%、95.5%、95.5%;在发病15 d后,三者的敏感性分别为84.2%、97.4%、97.4%。SARS-CoV-2IgM抗体在发病后第5～13天出现转阳趋势,在发病第18天后可观察到转阴趋势;SARS-CoV-2IgG抗体在第5天出现转阳趋势,之后持续阳性。结论血清SARS-CoV-2 IgM抗体和IgG抗体可作为COVID-19的辅助诊断指标,对其连续监测有助于判断疾病进程。     

新型冠状病毒特异性IgM/IgG抗体检测的临床应用价值

目的评价新型冠状病毒(SARS-CoV-2)特异性IgM和IgG抗体在新型冠状病毒肺炎(COVID-19)患者中的临床价值。方法收集2020年1月1日至3月13日在长江大学附属第一医院住院的COVID-19患者108例、疑似患者23例以及其他病例90例,采用化学发光法检测所有研究对象的SARS-CoV-2特异性IgM和IgG抗体,以SARS-CoV-2核酸RT-PCR检测结果作为比对标准,对其进行评价,并分析抗体与疾病病程之间的关系。结果确诊患者的首发症状以发热、咳嗽、乏力为主。重型/危重型患者的年龄明显高于普通型患者。IgM/IgG联合检测比IgM和IgG单独检测的敏感性高。IgM/IgG诊断的敏感性、特异性、准确性、阳性似然比、阴性似然比分别为98.1%、89.4%、93.7%、9.24、0.02。普通型和重型/危重型IgM或IgG抗体阳性率差异无统计学意义。不同时间段IgM/IgG抗体下降的程度不一样。结论SARS-CoV-2特异性IgM和IgG抗体检测对COVID-19的诊断很重要,联合RT-PCR可以更好地排除或确诊,避免疾病漏诊。     

新型冠状病毒肺炎患者IgM抗体与血细胞计数及C反应蛋白的相关性研究

目的 探讨白细胞计数、C反应蛋白及新型冠状病毒(SARS-CoV-2)特异性IgM抗体在新型冠状病毒感染的肺炎(COVID-19)患者临床诊断中的应用价值。方法 对59例COVID-19确诊患者疾病早期的外周血白细胞、淋巴细胞及C反应蛋白进行检测分析,并采用胶体金免疫层析技术检测不同病程患者血清中SARS-CoV-2特异性IgM抗体的水平。结果①59例确诊患者中,白细胞计数正常或降低者为57例(96.61%),淋巴细胞计数降低为20例(33.9%),C反应蛋白升高者为41例(69.49%)。COVID-19患者与健康人群相比,外周血白细胞、淋巴细胞及C反应蛋白的差异有统计学意义(P 0.05);②59例确诊患者中,52例(88.14%)患者血清SARS-CoV-2特异性IgM抗体检测为阳性,健康体检者IgM抗体均为阴性。COVID-19患者在病程第(0～6)d、(7～10)d、(11～15)d、(16～20)d血清SARS-CoV-2特异性IgM抗体阳性率分别为25%、81.82%、90%、100%。③IgM阳性组与IgM阴性组比较,外周血白细胞、淋巴细胞及C反应蛋白水平的差异均无统计学意义(P0.05)。结论 ①机体感染SARS-CoV-2后,外周血白细胞计数一般正常或减低,部分患者出现淋巴细胞减少,常伴有C反应蛋白升高。动态观察白细胞、淋巴细胞和C反应蛋白的变化,对于COVID-19的临床诊断和病情观察具有重要意义。②胶体金免疫层析技术检测患者血清中的SARS-CoV-2特异性IgM抗体可用于SARS-CoV-2感染患者的辅助诊断。     

新型冠状病毒肺炎患者血清SARS-CoV-2 抗体的检测分析

目的 分析新型冠状病毒肺炎（corona virus disease 2019,COVID-19） 患者血清新型冠状病毒（severeacute respiratory syndrome coronavirus 2,SARS-CoV-2）IgM 和IgG 抗体的变化规律及临床应用。方法 收集2020 年1 ～ 2 月初温州医科大学附属乐清医院收治的28 例SARS-CoV-2 核酸检测阳性的COVID-19 患者作为病例组,排除COVID-19 的30 例其他疾病患者作为对照组。利用全自动化学发光免疫分析技术检测所有研究对象的血清SARS-CoV-2IgM 和IgG,分析SARS-CoV-2 抗体的变化规律。结果 SARS-CoV-2 IgM,发病第1 ～ 6 天均阴性,发病第7 ～ 10 天,2 例患者阳性,发病第18 天后均转阳性,一个月左右达峰值,2 例患者分别在第49 天和第55 天出现9.80AU/ml（阴性）和10.79AU/ml（弱阳性）。SARS-CoV-2 IgG,发病第1 ～ 6 天均阴性,发病第8 天后均阳性。结论 发病10 天内SARS-CoV-2 IgM 阴性的患者不能排除SARS-CoV-2 感染,发病超过一周或多次核酸检测阴性的疑似患者检测SARSCoV-2 IgM 和IgG 具有重要意义。     

抗原交叉反应对新型冠状病毒血清特异性抗体检测的影响

新型冠状病毒肺炎(coronavirus disease 19,COVID-19)疫情发展迅速,早期诊断成为疫情防控的关键。2020年3月3日国家卫生健康委员会发布了最新版本的《新型冠状病毒肺炎诊疗方案(试行第七版)》,新版诊疗方案在原有的核酸检测确诊标准上新增了血清新型冠状病毒(SARS-CoV-2)特异性IgM和IgG抗体作为病原学诊断标准之一。然而,SARS-CoV-2血清抗体检测可受其他亚型的冠状病毒影响,从而造成检测结果的假阳性。该文针对新型冠状病毒的生物学特性、抗体的产生及检测方法等方面进行讨论,为COVID-19的辅助诊断提供参考。     

接种新型冠状病毒灭活疫苗后抗体水平变化分析

目的 分析健康人群接种新型冠状病毒(SARS-CoV-2)灭活疫苗后抗体水平的变化趋势。方法 选取2021年2月16日至8月17日该院接种SARS-CoV-2灭活疫苗医护人员146例为研究对象,其中男68例,女78例,采用磁微粒化学发光法检测特异性IgM、IgG和中和抗体,采用χ²检验和t检验进行比较。结果 疫苗接种前,特异性IgM、IgG和中和抗体检测结果均为阴性;接种后60 d特异性IgM、IgG和中和抗体阳性率分别为16.4%、93.1%、89.0%;接种后90 d特异性IgM、IgG和中和抗体阳性率分别为9.5%、90.4%、90.4%;接种后120 d特异性IgM、IgG和中和抗体阳性率分别为4.1%、86.3%、87.6%;接种后180 d,特异性IgM、IgG和中和抗体阳性率分别为0.0%、82.1%、91.7%。在疫苗接种后180 d, IgG和中和抗体阳性率之间差异有统计学意义(χ²=4.421,P=0.036)。男性在不同时间点的中和抗体竞争率明显低于女性(P<0.05),但阳性率与女性比较差异无统计学意义(P>...     

4例COVID-19患者不同类型标本的SARS-CoV-2核酸及抗体检测结果分析

目的选择合适的标本类型进行SARS-CoV-2检测,为新型冠状病毒肺炎(COVID-19)的早期诊断提供依据。方法采集咽拭子核酸检测阳性的4名COVID-19患者的鼻拭子、粪便、尿液、血液(分离血清)标本,用实时荧光RT-PCR进行SARS-CoV-2核酸检测,用化学发光法检测患者血清IgM和IgG。结果 4名患者咽拭子和3例粪便标本的SARS-CoV-2核酸检测阳性、2例鼻拭子核酸检测阳性;1例患者感染SARS-CoV-2一周内血清IgM及IgG出现,其余3例患者同期血清抗体检测阴性。结论 SARS-CoV2可以通过多种途径进行传播,选择多种类型标本联合检测可提高病毒的检出率;同时血清学抗体检测可以作为核酸检测的补充。     

SARS-CoV-2抗体用于COVID-19诊断的Meta分析

目的 采用Meta分析探讨严重急性呼吸综合征冠状病毒2(SARS-CoV-2)抗体对新型冠状病毒肺炎(COVID-19)的诊断价值.方法 检索PubMed、Embase、Cochrane Library、中国知网、万方和维普数据库,收集相关文献.计算合并敏感性、合并特异性、诊断比值比(DOR),分析文献的异质性,采用综...     

胶体金免疫层析法检测SARS-CoV-2血清抗体的临床价值探讨

目的通过对新型冠状病毒(SARS-CoV-2)免疫球蛋白(Ig)M和总抗体(即IgM/IgG)的检测,探讨应用胶体金免疫层析法(GICA法)在新型冠状病毒肺炎(COVID-19)诊断中的应用价值。方法收集76例患者共计83份血清,其中32例为SARS-CoV-2核酸阳性患者(确诊组),44例为SARS-CoV-2核酸阴性患者(对照组)。确诊组中7例患者为两次时间点采集标本。采用GICA法检测SARS-CoV-2 IgM和总抗体。结果GICA法检测SARS-CoV-2 IgM的灵敏度50.00%(16/32),特异度90.91%(40/44),符合率73.68%(56/76),阳性预测值80.00%(16/20)、阴性预测值71.43%(40/56);SARS-CoV-2总抗体检测的灵敏度68.75%(22/32)、特异度97.73%(43/44)、符合率85.53%(65/76)、阳性预测值95.65%(22/23)、阴性预测值81.13%(43/53)。GICA法检测SARS-CoV-2 IgM和总抗体的特异度均大于90%,符合率均大于70%,满足临床需求。结论GICA法检测SARS-CoV-2 IgM和总抗体,标本采集易标准化,报告时间快,灵敏度不高,但特异度较高,有辅助诊断的价值。     

Epidemiological study using IgM and IgG antibody titers against SARS-CoV-2 in The University of Tokyo,Japan (UT-CATS)

IntroductionThe worldwide pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has continued to date. Given that some of the patients with coronavirus disease 2019 (COVID-19) are asymptomatic, antibody tests are useful to determine whether there is a previous infection with SARS-CoV-2. In this study, we measured IgM and IgG antibody titers against SARS-CoV-2 in the serum of asymptomatic healthy subjects in The University of Tokyo, Japan.MethodsFrom June 2020, we recruited participants, who were students, staff, and faculty members of The University of Tokyo in the project named The University of Tokyo COVID-19 Antibody Titer Survey (UT-CATS). Following blood sample collection, participants were required to answer an online questionnaire about their social and health information. We measured IgG and IgM titers against SARS-CoV-2 using iFlash-SARS-CoV-2 IgM and IgG detection kit which applies a chemiluminescent immunoassay (CLIA) for the qualitative detection.ResultsThere were 6609 volunteers in this study. After setting the cutoff value at 10 AU/mL, 32 (0.48%) were positive for IgG and 16 (0.24%) for IgM. Of six participants with a history of COVID-19, five were positive for IgG, whereas all were negative for IgM. The median titer of IgG was 0.40 AU/mL and 0.39 AU/mL for IgM. Both IgG and IgM titers were affected by gender, age, smoking status, and comorbidities.ConclusionsPositive rates of IgG and IgM titers were relatively low in our university. Serum levels of these antibodies were affected by several factors, which might affect the clinical course of COVID-19.     

Comparison of SARS-CoV-2 IgM and IgG seroconversion profiles among hospitalized patients in two US cities

The clinical and public health utility of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serologic testing requires a better understanding of the dynamics of the humoral response to infection. To track seroconversion of IgG and IgM antibodies in patients with SARS-CoV-2 infection and its association with patient and clinical factors and outcomes. Residual patient specimens were analyzed on the Abbott ARCHITECT i2000 instrument using the Abbott SARS-CoV-2 IgG assay and prototype SARS-CoV-2 IgM assay. Age, sex, comorbidities, symptom onset date, mortality, and specimen collection date were obtained from electronic medical records. Three hundred fifty-nine longitudinal samples were collected from 89 hospitalized patients 0 to 82 days postsymptom onset. Of all, 51.7% of the patients developed IgG and IgM antibodies simultaneously; 32.8% seroconverted for IgM before IgG. On average, patients seroconverted for IgG by 8 days and for IgM by 7 days postsymptom onset. All patients achieved IgG seropositivity by 19 days and IgM seropositivity by 17 days. Median time to IgG and IgM seroconversion was prolonged and initial levels of IgG were lower in immunocompromised patients and patients <65 years of age compared to immune competent patients and those ≥65 years of age. Immunocompromised patients also had persistently lower levels of IgM that peaked on day 17.6 and decreased thereafter compared to immune competent patients. IgM seroconversion in patients who died reached significantly higher levels later after symptom onset than in those who recovered. SARS-CoV-2 infected patients have similar time to seroconversion for IgG and IgM. However, differences in immune status and age alter time to seroconversion. These results may help guide serologic testing application in COVID-19 management.     

High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies

ObjectivesSeveral serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performance of the iFlash® anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated.Design & MethodsThe precision, carry-over, linearity, limit of blank, detection and quantification were assessed. Sensitivity analysis was performed by using 178 sera collected from 154 RT-PCR confirmed COVID-19 patients. The specificity analysis was performed from 75 selected non-SARS-CoV-2 sera with a potential cross-reaction to the SARS-CoV-2 immunoassay.ResultsThis iFlash® SARS-CoV-2 assay showed excellent analytical performance. After 2 weeks since symptom onset, the sensitivities for IgM and IgG were 62.2% (95% CI: 52.3–71.2%) and 92.9%% (95% CI: 85.7–96.7%), respectively by using the cut-off provided by the manufacturer. After cut-off optimization (i.e. >2.81 for IgM and >4.86 for IgG), the sensitivity for IgM and IgG were 81.6 (95% CI: 72.7–88.1%) and 95.9% (95% CI: 89.4–98.7%), respectively. Optimized cut-off for IgG improved the sensitivity to reach 100% (95%CI: 87.6–100) from 28 days since symptom onset.ConclusionsThis study shows that the iFlash® SARS-CoV-2 assay from YHLO biotechnology, has satisfactory analytical performance. Nevertheless, the sensitivity of the IgM is limited for a proper clinical use compared to IgG. The determination of anti-SARS-CoV-2 IgG antibodies from 28 days since symptom onset was associated with high sensitivity, especially using optimized cut-offs (i.e. 100%).     

NLR、PCT、CRP联合检测对早期COVID-19的诊断价值

目的 探讨中性粒细胞/淋巴细胞比值(NLR)、降钙素原(PCT)和C反应蛋白(CRP)对早期新型冠状病毒肺炎(COVID-19)的诊断价值.方法 选取咸宁市第一人民医院230例疑似COVID-19患者,根据胸部电子计算机断层扫描(CT)、严重急性呼吸综合征冠状病毒2(SARS-CoV-2)核酸、病毒血清学抗体和血培养检...     

Factors associated with high antibody titer following coronavirus disease among 581 convalescent plasma donors: A single-center cross-sectional study in Japan

IntroductionThe ability to predict which patients with a history of coronavirus disease (COVID-19) will exhibit a high antibody titer is necessary for more efficient screening of potential convalescent plasma donors. We aimed to identify factors associated with a high immunoglobulin G (IgG) titer in Japanese convalescent plasma donors after COVID-19.MethodsThis cross-sectional study included volunteers undergoing screening for convalescent plasma donation after COVID-19. Serum anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S-protein IgG antibodies were measured using a high-sensitivity chemiluminescence enzyme immunoassay.ResultsIgG antibodies were measured in 581 patients, 534 of whom had full information of selected independent variables. Multiple linear regression analysis revealed that increasing age (1.037 [1,025, 1.048]), days from symptom onset to sampling (0.997 [0.995, 0.998]), fever (1.664 [1.226, 2.259]), systemic corticosteroid use during SARS-CoV-2 infection (2.382 [1.576, 3.601]), and blood type AB (1.478 [1.032, 2.117]) predict antibody titer.ConclusionOlder participants, those who experienced fever during infection, those treated with systemic corticosteroids during infection, those from whom samples were obtained earlier after symptom onset, and those with blood type AB are the best candidates for convalescent plasma donation. Therefore, these factors should be incorporated into the screening criteria for convalescent plasma donation after SARS-CoV-2 infection.