新型冠状病毒肺炎病例尿液SARS-CoV-2特异性IgM、IgG抗体结果分析

目的:探讨尿液严重急性呼吸综合征冠状病毒2特异性抗体免疫球蛋白M(IgM)和免疫球蛋白G(IgG)的临床应用价值。方法:选取30例新型冠状病毒肺炎康复期患者,于出院后第14日采集研究对象的血清及尿液标本,分别用磁微粒全自动化学发光免疫分析系统化学发光免疫分析仪(Axceed 260)和新型冠状病毒(2019-nCOV)IgM/IgG检测试剂盒(磁微粒化学发光法)检测SARS-CoV-2特异性IgM/IgG抗体,并选取10例无SARS-CoV-2接触史健康体检者作为对照。应用线性回归分析血清IgM与尿液IgM、血清IgG与尿液IgG抗体水平的相关性,并通过Logistic回归形成联合预测因子绘制ROC曲线并计算曲线下面积评估其诊断价值。结果:COVID-19康复期患者血清IgM与尿液IgM、血清IgG与尿液IgG抗体水平分别呈正相关性(均P<0.001);与健康对照组相比,COVID-19组尿液特异性IgM、IgG抗体水平高,其中尿液特异性IgM抗体差异有统计学意义(P=0.043)。通过Logistic回归形成联合预测因子绘制ROC曲线,结果显示尿液IgM、IgG抗体联合检测AUC为0.713。结论:尿液SARS-CoV-2 IgM、IgG抗体检测作为一种无创快速简便的新型检测方法,为COVID-19诊断提供了新思路。

Correlation of serum SARS-CoV-2 IgM and IgG serology and clinical outcomes in COVID-19 patients:Experience from a tertiary care centre

BACKGROUND The severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)virus has become a pandemic for the last 2 years.Inflammatory response to the virus leads to organ dysfunction and death.Predicting the severity of inflammatory response helps in managing critical patients using serology tests IgG and IgM.AIM To investigate the correlation of the serology(IgM and IgG)with reverse transcriptase polymerase chain reaction(RT-PCR)status,disease severity[mild to critical],intensive care unit(ICU)admission,septic shock,acute kidney injury,and in-hospital mortality.METHODS We conducted a longitudinal study to correlate serum SARS-CoV-2 immunoglobulin M(IgM)and immunoglobulin G(IgG)serology with clinical outcomes in coronavirus disease 2019(COVID-19)patients.We analyzed patient data from March to December 2020 for those who were admitted at All India Institute of Medical Sciences Rishikesh.Clinical and laboratory data of these patients were collected from the e-hospital portal and analyzed.A correlation was seen with clinical outcomes and was assessed using MS Excel 2010 and SPSS software.RESULTS Out of 494 patients,the mean age of patients was 48.95±16.40 years and there were more male patients in the study(66.0%).The patients were classified as mild-moderate 328(67.1%),severe 131(26.8%),and critical 30(6.1%).The mean duration from symptom onset to serology testing was 19.87±30.53 d.In-hospital mortality was observed in 25.1%of patients.The seropositivity rate(i.e.,either IgG or IgM>10 AU)was 50%.IgM levels(AU/mL)(W=33428.000,P≤0.001)and IgG levels(AU/mL)(W=39256.500,P≤0.001),with the median IgM/IgG levels(AU/mL),were highest in the RT-PCR-Positive group compared to RT-PCR-Negative clinical COVID-19.There was no significant difference between the two groups in terms of all other clinical outcomes(disease severity,septic shock,ICU admission,mechanical ventilation,and mortality).CONCLUSION The study showed that serology levels are high in RT-PCR positive group compared to clinical COVID-19.However,serology cannot be useful for the prediction of disease outcomes.The study also highlights the importance of doing serology at a particular time as antibody titers vary with the duration of the disease.In week intervals there was a significant correlation between clinical outcomes and serology on week 3.

血清SARS-CoV-2 IgM和IgG抗体阳性患者血常规及肾功能参数分析

目的了解新型冠状病毒(SARS-CoV-2)IgG抗体阳性患者的血常规及肾功能参数特点,鉴别诊断SARS-CoV-2感染患者及抗体阳性患者的血液指标,为早期临床诊断提供依据。方法回顾性分析常州市第一人民医院2020年3月19-31日门诊检测SARS-CoV-2 IgG和IgM抗体阳性患者,体检中心健康成年人及传染病院核酸阳性确诊的SARS-CoV-2感染患者临床资料。所有患者均检测血常规、肾功能,以及影像学CT平扫胸部检查,选择有鉴别意义的标志物。结果新型冠状病毒肺炎患者白细胞计数、淋巴细胞计数及嗜酸性粒细胞计数均明显低于健康成年人,差异均有统计学意义(P<0.05);肾功能参数中,新型冠状病毒肺炎患者的肌酐明显高于健康成年人,差异有统计学意义(P<0.05)。SARS-CoV-2 IgM和IgG抗体阳性患者与健康成年人比较,白细胞计数差异无统计学意义(P>0.05);但淋巴细胞计数明显低于健康成年人,差异有统计学意义(P<0.05);肾功能参数中,两组肌酐水平比较,差异无统计学学意义(P>0.05)。结论 SARS-CoV-2 IgM和IgG抗体阳性提示为感染中后期或既往感染,抗体阳性核酸检测阴性是否为假阳性或无症状感染者自愈值得临床进一步观察研究。血常规及肾功能参数在鉴别诊断中存在一定意义,可为核酸及CT诊断提供补充。

SARS-CoV-2 IgG和IgM抗体在诊治新型冠状病毒肺炎的应用价值

目的探讨化学发光法检测SARS-CoV-2 IgM/IgG抗体在辅助诊疗新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)中的应用价值。方法将203例COVID-19确诊患者作为确诊组,158例其他科室的非COVID-19患者和50例正常献血者共208例作为对照组,采用化学发光的方法进行检测。结果SARS-CoV-2 IgG抗体检测的临床灵敏度、特异性、阳性预测值、阴性预测值分别为85.7%、99.0%、98.8%、87.6%;SARS-CoV-2 IgM抗体检测的临床灵敏度、特异性、阳性预测值、阴性预测值分别为66.5%、98.0%、97.1%、75.0%;SARS-CoV-2 IgG和IgM抗体联合检测的临床灵敏度、特异性、阳性预测值、阴性预测值分别为89.6%、96.8%、97.3%、87.9%;SARS-CoV-2 IgG和IgM抗体在检出率无统计学差异的情况下,重症组距离发病日期的平均检测时间为10.8(10.8±4.1)d,早于轻症组的13.3(13.3±6.4)d,差异有统计学意义(P=0.017);IgG阴性组的中位检测时间为发病后7.0(5.0~12.0)d,早于IgG阳性组的13.5(10.0~17.0)d,差异具有统计学意义(P=0.0001);IgM阴性组的中位检测时间为发病后11.0(6.0~16.0)d,早于IgM阳性组的14.0(10.0~17.0)d,差异具有统计学意义(P=0.016)。结论化学发光法检测新型冠状病毒IgM和IgG抗体的方法具有较好的特异性和敏感性,可辅助诊断COVID-19,弥补病毒核酸检测的不足;检测时间是影响抗体结果的主要因素,较早检出SARS-CoV-2 IgM/IgG抗体可能预示着病情更加严重。

SARS-CoV-2 IgM、IgG抗体检测在新型冠状病毒肺炎中的诊断价值研究

目的探讨化学发光法检测新型冠状病毒(SARS-CoV-2)IgM、IgG抗体在新型冠状病毒肺炎(COVID-19)诊断中的价值。方法选取确诊为COVID-19的25例患者作为COVID-19确诊组,同期疑似COVID-19的17例患者作为COVID-19疑似组,另选取排除COVID-19的健康者60例作为对照组。采用化学发光法对各组进行SARS-CoV-2 IgM、IgG抗体检测,并对检测结果进行分析。结果COVID-19确诊组的25例患者中,有24例患者IgM和IgG抗体均为阳性,检测灵敏度为96%(24/25)。COVID-19疑似组的17例患者中,共检测出2例IgM和IgG抗体同时阳性患者,1例单独IgM抗体阳性患者和1例单独IgG抗体阳性患者。对照组中未检测出IgM或IgG抗体阳性。结论SARS-CoV-2 IgM和IgG抗体检测在COVID-19患者,尤其是疑似COVID-19患者的筛查、诊断中具有一定价值。

Clinical Performance of SARS-CoV-2 IgG and IgM Tests Using an Automated Chemiluminescent Assay

Serology tests for viral antibodies provide an important tool to support nucleic acid testing for diagnosis of the novel coronavirus disease 2019(COVID-19)and is useful for documenting previous exposures to SARS-CoV-2,the etiological agent of COVID-19.The sensitivities of the chemiluminescent SARS-CoV-2 IgG/IgM immunoassay were assessed by using serum samples collected from 728 patients testing positive for SARS-CoV-2 RNA.The specificity was evaluated on a panel of 60 serum samples from non-COVID-19 patients with high levels of rheumatoid factor,antinuclear antibody,or antibodies against Epstein-Barr virus(EBV),cytomegalovirus(CMV),mycoplasma pneumonia,human respiratory syncytial virus(RSV),adenovirus,influenza A or influenza B.The imprecision and interference were assessed by adopting the Clinical and Laboratory Standards Institute(CLSI)EP15-A2 and EP7-A2,respectively.Sensitivities between 1 and 65 days after onset of symptoms were 94.4%and 78.7%,for IgG and IgM test,respectively.The sensitivity increased with the time after symptom onset,and rose to the top on the 22nd to 28th days.The total imprecision(CVs)was less than 6.0%for IgG and less than 6.5%for IgM.Limited cross-reactions with antibodies against EBV,CMV,mycoplasma pneumonia,human RSV,adenovirus,influenza A or influenza B were found.These data suggested the chemiluminescent SARS-CoV-2 IgG and IgM,assay with reliable utility and sensitivity,could be used for rapid screening and retrospective surveillance of COVID-19.

Human IgM and IgG Responses to an Inactivated SARS-CoV-2 Vaccine

Objective:The ongoing COVID-19 pandemic warrants accelerated efforts to test vaccine candidates.To explore the influencing factors on vaccine-induced effects,antibody responses to an inactivated SARS-CoV-2 vaccine in healthy individuals who were not previously infected by COVID-19 were assessed.Methods:All subjects aged 18-60 years who did not have SARS-CoV-2 infection at the time of screening from June 19,2021,to July 02,2021,were approached for inclusion.All participants received two doses of inactivated SARS-CoV-2 vaccine.Serum IgM and IgG antibodies were detected using a commercial kit after the second dose of vaccination.A positive result was defined as 10 AU/mL or more and a negative result as less than 10 AU/mL.This retrospective study included 97 infection-naive individuals(mean age 35.6 years;37.1%male,62.9%female).Results:The seropositive rates of IgM and IgG antibody responses elicited after the second dose of inactivated SARS-CoV-2 vaccine were 3.1%and 74.2%,respectively.IgG antibody levels were significantly higher than IgM levels(P<0.0001).Sex had no effect on IgM and IgG antibody response after the second dose.The mean anti-IgG level in older persons(≥42 years)was significantly lower than that of younger recipients.There was a significantly lower antibody level at>42 days compared to that at 0-20 days(P<0.05)and 21-31 days(P<0.05)after the second dose.Conclusion:IgG antibody response could be induced by inactivated SARS-CoV-2 vaccine in healthy individuals(>18 years),which can be influenced by age and detection time after the second dose of vaccination.

人体感染SARS-CoV-2病毒后血清特异性IgM/IgG抗体动态变化及临床意义分析

目的通过回顾性分析66例新型冠状病毒肺炎(COVID-19)康复者资料,研究新型冠状病毒(SARS-CoV-2)抗体的动态变化规律,为新冠肺炎防治及临床实践提供依据。方法以北京佑安医院自2020年1月21日以来收治并参与随访的66例新冠肺炎康复者为研究对象,采用胶体金法检测其出院后第14天、28天、56天、84天和168天IgM/IgG抗体。结果将新冠肺炎康复者按照临床分型分为两组,即普通型组、重型与危重型组。从抗体类别分析,IgM抗体在随访第14天、28天阳性率分别为41.9%、41.5%,在随访第56天、84天和168天分别为11.9%、6.5%、7.1%;两组间差异有统计学意义(P<0.05)。IgG抗体阳性率在第14天、28天阳性率达到96.8%、94.3%,第56天、84天和168天分别为94.9%、91.3%、96.4%;两组间差异无统计学意义(P>0.05)。随康复时间延长,IgM、IgG抗体双阳性占比逐渐下降,IgM、IgG抗体双阴性占比逐渐上升。按临床分型来看,IgM抗体从随访第14天至168天,重型与危重型组阳性率始终高于普通型组。从随访第14天至28天,两组间差异有统计学意义(P<0.05),重型与危重型组IgM抗体转阴中位数为75.5d,普通型组为57.0d,重型与危重型组IgM抗体阴转时间长于普通型组,两组间差异无统计学意义(P>0.05)。IgG抗体自随访第14天至随访168天,普通组、重型与危重型组均保持较高水平的阳性率,两组间差异无统计学意义(P>0.05)。结论SARS-CoV-2 IgM抗体反应可能与疾病严重程度呈正相关;大部分新冠康复者体内IgG抗体可维持较长时间,但其是否可作为中和性抗体应对新冠突变株,以及部分特异性抗体转阴康复者机体免疫水平,仍有待进一步观察研究。

Persistence of Anti-SARS-CoV-2 IgM Antibody up to 8 Months Post-COVID-19

Here, we present a longitudinal analysis of two patients who recovered from COVID-19 more than 8 months prior but showed persistent serological detection of anti-SARS-CoV-2 IgM. We still do not know the exact reason for this prolonged persistence of IgM in these patients. To our knowledge, these are the first reports of IgM persistence in the context of SARS-CoV-2 infection and point to the need for no longer using IgM as a diagnostic criterion for acute or recent COVID-19. One should opt for gold standard molecular methodologies due to their high sensitivity and specificity.

单采血小板献血者新型冠状病毒IgM和IgG抗体水平监测结果分析及对血液安全的影响

目的监测无偿献血者感染SARS-CoV-2康复后IgM和IgG抗体阳性率及S/CO值的动态变化情况,为保障血液安全提供理论依据及数据支持。方法以符合纳入标准的单采血小板献血者54人为研究对象,采用全自动化学发光法,连续监测T1—T7共7个时间点(跨度14~15周)359份血液标本(血浆)SARS-CoV-2 IgM和IgG抗体。结果1)纳入符合标准共计54人,提供359份血液标本(血浆)用于检测,有效检测结果349份。2)时间段内IgM检测呈阳性11人,阳性率20.37%;IgM抗体S/CO值T1—T3逐步升高,T4—T7逐步下降。3)时间段内IgG检测呈阳性54人,阳性率100%;IgG抗体S/CO值随时间变化逐步降低。4)在T1—T7时间段内,SARS-CoV-2 IgG抗体S/CO值在性别(男/女)及年龄段(18~39岁/40~60岁)均无差异(P>0.05)。结论单采血小板献血者感染SARS-CoV-2康复后,2~14周SARS-CoV-2 IgG抗体阳性率为100%,IgG S/CO值随时间推移逐步下降,献血者SARS-CoV-2血清学特异性IgG、IgM抗体更长时间的动态变化规律值得进一步追踪研究。

Evaluation of Dynamic Changes of IgG and IgM in COVID-19 Patients by Different Detection Methods

Objective: To analyze the dynamic evaluation of chemiluminescence, colloidal gold, and immunofluorescence chromatography in detecting antibodies in COVID-19 patients within four weeks of infection, and to provide evidence for clinical application. Method: 74 patients with confirmed SARS-COV-2 infection in the local area were selected as the experimental group, while 231 patients with negative SARS-COV-2 results but not vaccinated with Covid19 vaccine were selected as the control group;during the first, second, third, and fourth weeks after enrollment in the experimental group, three methods were used to detect SARS-COV-2 IgG and IgM in patients’ blood: chemiluminescence method, colloidal gold antibody method, and immuno-fluorescence chromatography. In the control group, three methods were used to detect SARS-COV-2 IgG and IgM during physical examination for SARS-COV-2 nucleic acids. The ROC curve was drawn to analyze the value of each indicator in predicting SARS-COV-2 infection, and the kappa method was used to analyze the consistency of the detection results of each indicator. Results: There was no significant difference in the positive rates of SARS-COV-2 IgM and IgG antibodies detected by chemiluminescence, colloidal gold, and immunofluorescence chromatography during the four-week period (P > 0.05). The positive rates of SARS-COV-2 IgM and IgG antibodies detected by the three methods during the first week of infection were not higher than 60%;when the three methods were used to detect SARS-COV-2 IgM and IgG in vivo, the AUC diagnosed by the test results was less than 0.80 at the first week, the diagnostic efficacy of the three methods was above 0.95 from the second week to the fourth week, and the diagnostic efficacy of the three methods was higher than 0.97 at the fourth week. The diagnostic efficacy of the three methods was comparable;the three methods for detecting SARS-COV-2 IgM and IgG antibodies showed high consistency in four cycles. Conclusion: Chemiluminescence, colloidal gold, and immunofluorescence chromatography are highly consistent in the detection of SARS-COV-2 IgM and IgG antibodies, and can be used as an auxiliary diagnosis and efficacy observation of novel coronavirus infections according to the needs, but the positive rate of infected people in the first week is low.

Waning of Anti-Spike IgG Antibody Titer after COVID-19 Vaccination: Myth or Reality?

This observational prospective study was conducted on 25 patients who had received a full 3-dose COVID-19 vaccination scheme with a follow-up ranging from 12 to 19 months after the last injection. The aim of the study was focused on a single biological indicator the anti-spike IgG antibody titer. The age of the patients ranged from 51 to 85 years old. 15 out 25 patients (60%) presented a comorbidity. Our data showed a persistent positive anti-spike IgG antibodies titer ranging from 105 to 5680 BAU/mL (mean: 2661 BAU/mL) in all patients. In view of these results, systematic administration of a SARS-CoV-2 vaccine booster is questionable and should be individually tailored according to the patient medical condition and the anti-spike IgG antibody level.

磁微粒化学发光法与胶体金法在临床SARS-CoV-2抗体检测中的性能比较

目的:探讨磁微粒化学发光法(CLIA)与胶体金法检测新型冠状病毒抗体IgM、IgG的差异。方法:分别用CLIA与胶体金法对新型冠状病毒IgM、IgG抗体进行测定,分析两种检测方法检测新型冠状病毒抗体的敏感性以及最低检测限值。结果:CLIA检测新型冠状病毒IgM、IgG的S/CO值小于1时,胶体金法检测均为阴性;S/CO值大于10时,胶体金法检测IgM的阳性率为100%、检测IgG的阳性率为99.14%;S/CO值大于1小于10时,胶体金法检测新型冠状病毒IgM与IgG的阳性率分别为0.87%与1.56%。结论:CLIA法检测新型冠状病毒IgM、IgG的检出率高于胶体金法;CLIA检测新型冠状病毒IgM与IgG最低检测的S/CO值≥1判定为阳性,而S/CO值大于10时,胶体金法显示阳性,CLIA的阳性阈值更低。

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。

B-cell and antibody responses to SARS-CoV-2:infection,vaccination,and hybrid immunity

The emergence of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)in 2019 prompted scientific,medical,and biotech communities to investigate infection-and vaccine-induced immune responses in the context of this pathogen.B-cell and antibody responses are at the center of these investigations,as neutralizing antibodies(nAbs)are an important correlate of protection(COP)from infection and the primary target of SARS-CoV-2 vaccine modalities.In addition to absolute levels,nAb longevity,neutralization breadth,immunoglobulin isotype and subtype composition,and presence at mucosal sites have become important topics for scientists and health policy makers.The recent pandemic was and still is a unique setting in which to study de novo and memory B-cell(MBC)and antibody responses in the dynamic interplay of infection-and vaccine-induced immunity.It also provided an opportunity to explore new vaccine platforms,such as mRNA or adenoviral vector vaccines,in unprecedented cohort sizes.Combined with the technological advances of recent years,this situation has provided detailed mechanistic insights into the development of B-cell and antibody responses but also revealed some unexpected findings.In this review,we summarize the key findings of the last 2.5 years regarding infection-and vaccine-induced B-cell immunity,which we believe are of significant value not only in the context of SARS-CoV-2 but also for future vaccination approaches in endemic and pandemic settings.

新型冠状病毒感染后特异性IgM和IgG抗体变化规律的初步探索

目的探索新型冠状病毒(SARS-CoV-2)感染后体内特异性IgM和IgG抗体产生和变化的规律。方法回顾性分析泰康同济(武汉)医院2020年2月10日至3月27日收治的COVID-19患者。所有研究对象均检测血清中SARS-CoV-2特异性IgM和IgG抗体和病毒核酸。结果研究共纳入确诊病例483例、疑似病例285例。确诊和疑似患者的IgM阳性率为分别为27.1%(131)、31.9%(91),差异无统计学意义(P=0.156);特异性IgG阳性率分别为88.8%(429)、71.6%(204),差异无统计学意义(P <0.001);IgM和IgG双阳性率分别为25.7%(124)、30.5%(87),差异无统计学意义(P=0.145)。发病1~2周IgM和IgG阳性率分别为18.4%(9/49)、38.8%(19/49)。随着病程延长,抗体阳性率逐渐增高,第7~8周达到峰值,分别为33.9%(105/310)、93.2%(289/310),第8周以后抗体阳性率又开始下降。入院复查核酸检测,阳性的有104例,其中IgM、IgG、IgM联合IgG的阳性率分别为26.9%(28),88.5%(92),26.0%(27);核酸阴性的病例有615例,三者的阳性率分别为29.1%(179)、81.3%(500)、27.6%(170)。核酸结果分别与IgM、IgG、IgM联合IgG的阳性率差异无统计学意义(P> 0.05)。结论特异性IgM和IgG抗体检测可以作为诊断COVID-19的辅助方法。尚需要更多研究进一步探索抗体在人体内产生和变化的规律。

新型冠状病毒特异性抗体IgM、IgG的临床意义

目的分析新型冠状病毒(SARS-CoV-2,简称新冠病毒)特异性抗体IgM、IgG对新型冠状病毒肺炎(COVID-19,简称新冠肺炎)的诊断价值。方法1)收集2020年3月上旬在本院发热门诊就诊的全部145名患者的新冠病毒IgM、IgG抗体(胶体金法)和核酸(荧光定量PCR法)检测结果(发热组),做配对卡方检验;2)收集3月5日当天做新冠病毒IgM、IgG抗体检测的612名新冠肺炎确诊患者(来自本院2月~3月作为新冠肺炎定点治疗医院收治的1500名新冠肺炎患者)的新冠病毒IgM、IgG抗体检测结果(新冠肺炎组),并跟踪随访患者出院后30、60 d的新冠病毒IgM、IgG抗体和核酸检测结果;通过对各组(间)的统计分析,明确抗体检测阳性率及抗体变化趋势等。结果1)发热组:新冠病毒抗体IgM阳性、IgG阳性及IgM合并IgG双阳性的比例分别为26.21%(38/145)、54.48%(79/145)及26.21%(38/145)(P<0.01);核酸检测阳性率4.14%(6/145)低于抗体阳性率(P<0.01);IgM和IgG均为阴性而核酸检测阳性的比例为0.69%(1/145)。2)新冠肺炎组:以2~98 d为观察时段,抗体阳性率由5%(1/20)逐渐增至97.8%(87/89);>56 d阳性率平缓下降。2~14 d的IgM阳性率5%(1/20)、IgG阳性率65%(13/20),≥14~56 d IgM阳性率47.68%(277/581)、IgG阳性率94.15%(547/581),≥56 d IgM、IgG阳性率均下降。所有患者住院期间IgM抗体阳性率45.8%(280/612),IgG抗体阳性率93.1%(570/612)。出院后(其中15名患者因转入他院治疗无后期复查数据)1和2个月的新冠病毒核酸检测均为阴性,出院后2个月IgG阳性率≥80%(487/597)、IgM阳性率≥40%(240/597)。结论胶体金法能很好地检测新冠病毒IgM、IgG抗体,阳性率高于核酸检测,其中IgG抗体产生早,阳性率高,持续时间长;联合应用胶体金抗体检测与核酸检测方法有助于提高新冠肺炎确诊和疑似病例的排除诊断。

新冠病毒SARS-CoV-2检测方法研究进展

自2019年新冠肺炎(COVID-19)出现以来,疫情已波及全球100多个国家,截至2020年5月8日,全球范围内已有累计确诊新冠肺炎病例3 767 744例,累计死亡病例259 593例。应对新冠肺炎疫情最有效的方式是快速检测、隔离、治疗,可见新冠病毒的快速、准确检测是遏制疫情蔓延的关键技术手段。首先介绍了新冠病毒SARS-CoV-2结构及与生物体的作用机理,之后详细总结了目前新冠病毒SARS-CoV-2检测方法进展,并对各种方法的优缺点进行比较,最后对检测方法存在的问题及可能改进之处进行了展望。

火神山医院146例新型冠状病毒肺炎康复者特异性IgM、IgG抗体定量检测与分析

目的探讨新型冠状病毒肺炎康复者新型冠状病毒(2019 noval coronavirus,2019-nCoV)特异性IgM、IgG抗体的产生规律。方法收集2020年2月10日-3月10日收治的146例新型冠状病毒肺炎康复者的血液标本,依据发病时间到标本采集时间分为A组20例、B组58例、C组46例、D组22例,发病时间分别为≤30 d、31~39 d、40~49 d、≥50 d。检测4组2019-nCoV特异性IgM、IgG抗体浓度。结果B、C、D组IgG抗体浓度高于A组,且C、D组高于B组(P<0.05,P<0.01),而4组IgM抗体浓度比较差异无统计学意义(P>0.05)。C、D组IgG抗体浓度比较差异无统计学意义(P>0.05)。结论新型冠状病毒肺炎康复者IgM、IgG抗体浓度均增高,且持续时间较长。IgM抗体浓度随发病时间的延长有下降趋势,IgG抗体浓度随发病时间的延长而逐步增高,发病50 d后仍维持较高水平。

550例COVID-19患者血清IgM和IgG检测结果分析

目的分析新型冠状病毒肺炎(COVID-19)患者血清抗体IgM和IgG水平,为临床诊疗提供依据。方法2020年2月27日—3月5日采用化学发光法定量检测法检测COVID-19确诊住院患者的血清抗体水平,统计分析不同病程(<7 d、7~14 d、>14 d)、不同性别及不同年龄段(<18岁、18~岁、41~岁、>65岁)患者抗体检测阳性率及抗体水平的差异。结果550例确诊COVID-19患者中,男性253例,女性297例,中位年龄为61(50,69)岁。IgM和/或IgG抗体总体阳性率为92.00%,IgG总体阳性率为91.45%,IgM总体阳性率为76.18%。IgM或IgG阳性率随疾病进程逐渐升高,阳性率从早期的31.25%上升至94.82%。病程超过14 d后IgG抗体阳性率高于IgM抗体阳性率(χ^(2)=49.697,P<0.001)。不同年龄组间抗体阳性率比较,差异有统计学意义(χ^(2)=15.339,P=0.002),以41~及>65岁年龄组阳性率较高;不同性别组抗体阳性率比较,差异无统计学意义(χ^(2)=0.006,P=0.094)。IgM在发病后1~2周内产生,2~3周内达到峰值,4周以后逐渐降低到正常水平;而IgG在发病后1周左右开始产生,3周左右达到峰值,50 d仍持续保持稳定水平。不同年龄段及不同性别组患者抗体IgM和IgG水平比较,差异无统计学意义(均P>0.05)。结论IgM或IgG在病程早期的阳性率相对较低,随疾病进程逐渐升高,但抗体水平未呈现出年龄和性别的差异,抗体检测能辅助COVID-19患者的诊断。