献血者抗-EV71抗体检测及其意义的探讨

目的 了解献血者EV71型病毒感染状况,探讨抗-EV71抗体的应用价值.方法 用ELISA法检测献血者血清中的抗-EV71IgM和IgG抗体.结果 抗-EV71IgM阳性率为1.28%,抗-EV71IgG阳性率为15.74%.18-29年龄抗-EV71IgG阳性率17.58%,30-39年龄抗-EV71IgG阳性率19.70%,40-55年龄抗-EV71IgG阳性率8.97%.女性阳性率抗-EV71IgG20.59%,男性抗-EV71IgG阳性率14.67%.结论 部分献血者体内含有EV71抗体,可用其血浆制成特异性免疫球蛋白或直接将血浆用于临床治疗EV71感染重症患者.     

不同方法检测肠道病毒71型IgM抗体在手足口病诊断中的意义

目的：研究免疫层析法（ICA）和酶联免疫吸附法（ELISA）检测肠道病毒71型（EV71）IgM 抗体在手足口病诊断中的意义。方法采集135例手足口病确诊患儿和44例排除手足口病诊断的患儿血清标本,采用ICA及ELISA检测EV71 IgM 抗体。结果135例手足口病患儿,ICA、ELISA 检测 EV71 IgM 抗体阳性率分别为21．48％（29/135）和20．74％（27/135）;44例非手足口病患儿,ICA、ELISA检测EV71 IgM抗体阳性率均为0．00％（0/44）。结论ICA或ELISA检测EV71 IgM抗体阳性者均可确诊为手足口病,但检测结果为阴性者,不能排除手足口病的可能性,应结合临床表现进行诊断。     

捕获ELISA法测定抗EV71-IgM抗体用于EV71感染早期诊断

目的探讨捕获ELISA法测定抗肠道病毒71型(EV71)IgM抗体在EV71感染所致手足口病(HFMD)早期诊断中的价值。方法以实时荧光RT-PCR检测89例临床初诊为HFMD患儿的粪便、疱疹液、咽拭子或肛拭子的肠道病毒RNA。用40例排除HFMD的5岁以下儿童血清为抗EV71-IgM抗体阴性对照,以捕获ELISA法检测患儿不同发病期血清中抗EV71-IgM抗体。结果经实时荧光RT-PCR检测,89例HFMD患儿粪便、疱疹液、咽拭子或肛拭子中EV71感染28例,柯萨奇病毒A16(CA16)感染43例,非EV71和CA16的肠道病毒感染14例,非肠道病毒感染4例。EV71感染者发病1～3 d、4～6 d及>6 d的血清抗EV71-IgM抗体阳性率分别为81.3%、100%和100%;CA16感染者分别为10.0%、26.4%和65.7%;非EV71和CA16的肠道病毒感染者及非肠道病毒感染者在发病1～3 d和4～6 d无1例阳性;阴性对照组无1例阳性。抗EV71-IgM抗体在EV71感染的早期(急性期)的诊断敏感性和特异性分别为81.3%和92.9%。结论 EV71感染者与CA16感染者血清抗EV71-IgM抗体在发病4 d后存在较明显的交叉反应。抗EV71-IgM抗体可用作EV71感染早期诊断的血清学标志物。     

手足口病相关肠道病毒感染血清IgM抗体交叉反应及动态变化

目的分析手足口病相关肠道病毒间IgM抗体交叉反应及动态产生过程,评价抗体捕获法检测肠道病毒71型(EV71)及柯萨奇病毒A组16型(CA16)感染的早期诊断价值。方法收集广州市妇女儿童医疗中心319名手足口病患者及疑似患者咽拭子319份、血标本565份。荧光定量PCR检测咽拭子标本,血清中和试验检测配对血清,结合两法结果为判断标准,将手足口病患者分为EV71、CA16及其他肠道病毒感染组;以捕获ELISA法检测不同发病时间EV71-IgM抗体及CA16-IgM抗体。结果发病第一天均能检测出EV71-IgM抗体及CA16-IgM抗体,阳性率分别为33.0%和25.0%,检出率分别在第5天和第7天达到100%,抗体可持续检出时间达数月。EV71感染血清CA16-IgM捕获ELISA法交叉反应率为25.0%,CA16感染血清EV71-IgM捕获ELISA法交叉反应率为28.0%。EV71-IgM和CA16-IgM抗体存在严重交叉反应,通过两者450 nm处吸光度(A450 nm)比值可以成功诊断97.1%EV71感染和93.0%CA16感染。同一天采集的肛拭子及血清标本检测结果表明,荧光定量PCR与ELISA法诊断EV71及CA16感染的结果差异无统计学意义。结论 EV71及CA16抗体捕获ELISA法是一种简单、有效的诊断方法,联合两种方法检测可以有效提高诊断特异性。     

肠道病毒71型IgM抗体在手足口病诊断中的临床应用价值研究

目的：探讨检测人肠道病毒71型(EV71)的IgM抗体对于手足口病的诊断价值。方法收集2012年1月至2014年5月期间,我院收治的初治手足口病患者41例,取血清标本以及咽拭子标本分别进行EV71 IgM抗体、EV71特异性核酸以及肠道病毒(EV)通用型核酸检测。结果本组41例患者入院第1dEV71 IgM抗体阳性率为56.1%,入院第2d累计阳性率为58.5%,入院第4d累计阳性率为78.0%,第5d累计阳性率为92.7%,第6d累计阳性率为92.7%,稳定期EV71 IgM抗体阳性结果显著高于同期Real time RT-PCR检测EV71特异性核酸结果(92.7%vs 73.2%),P<0.05;EV通用型核酸阳性率与EV 71 IgM抗体阳性率依次为78.0%(32/41)和92.7%(38/41),两组对比差异无统计学意义(P>0.05)。结论检测EV71 IgM抗体对于手足口病的早期诊断具有重要指导意义,值得推广应用。     

ELISA检测血清EV71-IgM诊断手足口病价值的Meta分析

目的系统评价酶联免疫吸附试验(ELISA)检测血清肠道病毒71型IgM抗体(EV71-IgM)诊断手足口病(HFMD)的价值。方法检索PubMed、Embase、Web of Science、Cochrane、维普、万方、中国知网以及中国医学生物文献数据库中有关用ELISA检测EV71-IgM诊断HFMD的文献,检索时限从建库至2015年1月。对符合纳入标准的文献进行资料提取、方法学质量评价,采用Meta-disc 1.4软件进行Meta分析。结果共纳入文献8篇,合计4 126例,其中HFMD患者1 484例,非HFMD患者2 642例。Meta分析结果显示,各研究间存在非阈值效应引起的异质性,合并灵敏度、特异度和诊断比值比分别为84%、90%、28.77;拟合综合受试者特征曲线(SROC)下面积为0.906 8。结论 ELISA检测血清EV71-IgM诊断HFMD有较高的诊断价值,但因纳入研究存在一些方法学缺陷,该结论尚需进一步开展高质量的诊断性试验来进行验证。     

联合检测炎症性肠病患者抗酿酒酵母细胞抗体和抗中性粒细胞抗体的临床意义

目的 探讨联合检测炎症性肠病(IBD)患者血清中抗酿酒酵母细胞抗体(ASCA)和抗中性粒细胞胞浆抗体(ANCA)对IBD诊断和鉴别诊断的应用价值.方法 用ELISA法和间接免疫荧光法分别测定159例IBD患者[溃疡性结肠炎(UC)97例,克罗恩病(CD)62例],167例主诉为腹痛、腹泻并除外IBD的患者和25名健康人血清中IgG型与IgA型ASCA和ANCA.结果 ASCA-IgA/IgG在CD组、UC组、疾病对照组和健康对照组中的阳性率分别为43.5%、14.4%、29.3%和0;CD组的阳性率显著高于UC组和疾病对照组(X2值分别为16.76、4.12,P分别<0.01、<0.05).ANCA在以上各组中的阳性率分别为8.1%、56.7%、4.8%和0;UC组中阳性率显著高于CD组和疾病对照组(X2值分别为38.08、90.47,P均<0.01);ASCA+/ANCA-组合诊断CD的敏感度、特异度、阳性预测值分别为40.3%,93.8%和80.6%;而ANCA+/ASCA-组合诊断UC的敏感度、特异度和阳性预测值分别为48.5%,98.4%和97.9%;ASCA在手术治疗与未手术治疗CD患者中的阳性率差异具有统计学意义(P=0.03).结论 ASCA或ANCA单项检测不能有效的筛选IBD患者,但2项指标联合检测有助于对UC和CD进行鉴别诊断.同时检测IgA型和IgG型ASCA可提高CD诊断的敏感度.中国人群中ASCA阳性可能与手术治疗相关.     

ELISA检测血清抗磷脂酶A_2受体抗体在膜性肾病中的应用探讨

目的探讨酶联免疫吸附试验(ELISA)检测血清抗磷脂酶A2受体抗体(抗PLA2R抗体)滴度在膜性肾病中的应用价值为疾病诊断及病情判断提供更特异的血清学指标。方法选取该院肾内科就诊行肾组织活检并确诊的膜性肾病患者34例,该院住院自身免疫性疾病及肾病综合征、肾功能不全患者32例,健康体检者12例,收集血清检测抗PLA2R抗体并结合血清总蛋白(TP)、清蛋白(ALB)、IgG、IgA、IgM、C3、C4指标,分析其对膜性肾病的诊断性能。结果抗PLA2R抗体滴度在膜性肾病组、疾病对照组、健康对照组中位数依次为22.1、2.0、2.0RU/mL,膜性肾病组与其他两组间比较差异有统计学意义(P0.05)。抗PLA2R抗体在膜性肾病组阳性17例(阳性率50%),阴性17例,疾病对照组及健康对照组均为阴性,其特异度与阳性预测值为100%。膜性肾病组TP、ALB、IgG与疾病对照组、健康对照组比较差异有统计学意义(P0.05);抗PLA2R抗体与血清TP、ALB、IgG、IgA、IgM、C3、C4的相关系数依次为-0.382、-0.344、-0.502、-0.295、0.062、0.005、0.241,与TP、ALB、IgG、IgA呈负相关(P0.01),与C4呈正相关(P0.05),与IgM、C3无相关性(P0.05)。结论抗PLA2R抗体在膜性肾病诊断中具有较高的特异性,可作为无法行肾活检患者的必要和特异性血清学检测指标,定量检测有助于病情判断。     

ELISA 检测KRT10_C 和COL6A3_C 短肽抗体的方法建立及作为RA 诊断的应用价值

目的 建立角蛋白I型细胞骨架10[keratin type I cytoskeletal 10,KRT10)和VI型胶原蛋白A3[collagen alpha-3(VI)chain,COL6A3]短肽抗体的ELISA检测方法,并探讨两种瓜氨酸化短肽抗体在类风湿关节炎(rheumatoid arthritis, RA)实验室诊断中的价值。方法 以合成短肽为包被抗原,抗人IgA,IgG及IgM为二抗,检测100例抗瓜氨酸化蛋白抗体(anti-citrullinated protein antibodies,ACPA)阳性组、100例健康对照组和29例RA确诊患者血清中的KRT10,KRT10_C,COL6A3及COL6A3_C短肽抗体水平,比较不同短肽抗体与RA的相关性,采用ROC曲线分析KRT10_C和COL6A3_C短肽抗体对于RA的诊断价值,并对此ELISA方法进行精密度评价。结果 与临床诊断相比,KRT10_C短肽抗体诊断RA的灵敏度为58.62%,特异度为52.17%,用于诊断抗CCP抗体阳性RA患者的ROC曲线下面积达0.895; COL6A3_C短肽抗体诊断RA的灵敏度为65.52%,特异度为78.95%,用于诊断抗CCP抗体阴性的RA患者的ROC曲线下面积可达0.956。ELISA检测值KRT10_C(以抗人IgG为二抗)的批内变异系数分别为11.2%(低值)、7.8%(中值)和6.7%(高值)。ELISA检测COL6A3_C(以抗人IgM为二抗)的批内变异系数分别为12.9%(低值)、8.4%(中值)和8.9%(高值)。结论 KRT10_C和COL6A3_C短肽抗体对RA诊断具有重要意义,有望加入并完善实验室诊断体系,提高RA的早期诊断率。     

抗烟曲霉果胶裂解酶A抗体检测对侵袭性曲霉病诊断价值的评估

目的 建立检测抗烟曲霉果胶酶A(pectate lyase A,PlyA)抗体的ELISA方法,评估其对侵袭性曲霉病(invasive aspergillosis,IA)的诊断价值。方法 用重组PlyA作为包被抗原,建立检测人抗PlyA IgG抗体的间接ELISA方法。检测97例IA患者、80例非IA患者和200例体检健康者血清。将所得结果与抗烟曲霉硫氧还蛋白还原酶(thioredoxin reductase,TR)抗体和抗烟曲霉二肽基肽酶V(dipeptidylpeptidase V fragment,DPPV)抗体结果比较。结果 抗PlyA IgG抗体ELISA方法的批内变异系数为5.3%,批间变异系数为10.9%。诊断IA的敏感度为62.9%,特异度为90.4%。非中性粒细胞缺乏IA患者和中性粒细胞缺乏组患者阳性率分别为72.3%和43.8%(χ²=7.493,P< 0.05)。抗PlyA,抗TR,抗DPPV抗体检测的阳性率分别为62.9%,60.8%和66.0%,三者差异无统计学意义(χ²=0.562,P> 0.05); 三种方法联合检测的阳性率可达到92.8%。结论 成功建立了检测抗PlyA IgG的ELISA方法; 抗体检测对非粒细胞减少IA患者的诊断价值均优于粒细胞减少IA患者; 联合三种抗体检测可提高诊断敏感度。     

肠道病毒71型 VP1基因的扩增、克隆、表达及蛋白分析

目的：对肠道病毒71型 VP1基因片段进行扩增、克隆、生物信息学分析、原核表达、纯化,初步证实重组表达产物的生物学活性。方法根据 GenBank 中 EV71序列设计一对特异性引物,以 EV71患者咽拭子标本中提取病毒核糖核酸为模板, RT-PCR 扩增 EV71 VP1基因,酶切后插入表达载体 pET28a。构建 pET28a-EV71 VP1原核表达载体。转化 E．coli DH5α,IPTG诱导表达,使用 SDS-PAGE 及 Western blot 分析表达结果,利用软件对测序结果进行生物信息学分析。纯化蛋白并包被反应板,用 ELISA 分别检测 EV71阳性与 COX A16阳性患者 VP-1 IgG 抗体,进行统计学分析。结果目的基因经 BLAST 比对,同源性与 GenBank 登录号为 JQ766207．1 EV71 VP1一致性达99％。EV71 VP1蛋白相对分子质量约为32×10^3,主要以包涵体形式存在。生物信息学分析得出,EV71 VP1蛋白为亲水性蛋白,无跨膜区,不具有 N-端信号肽序列,存在三级结构。ELISA 结果显示EV71阳性患者 OD 值为（2．425±0．521）,COX A16阳性患者 OD 值为（1．205±0．314）,健康对照组 OD 值为（0．353±0．128）。EV71 VP1蛋白检测敏感性和特异性分别为84％和88％。结论成功构建了 pET28a-EV71 VP1表达载体;通过对手足口患者血清进行 ELISA 初步分析,得出目的蛋白有较高的敏感性和特异性,初步证实具有生物学活性,可进一步用于 EV71诊断及疫苗的相关研究。     

两种不同方法检测肠道71型病毒的比较

目的研究不同方法检测肠道71型病毒的灵敏度和特异性。方法采集135例临床确诊为手足口病患儿和44例临床确诊为非手足口病患儿血清,分别用免疫层析法（ICA）和酶联免疫吸附试验（ELISA）检测抗肠道71型病毒IgM抗体。结果ICA法检出阳性病例29例,ELISA法检出阳性病例27例;ICA法和ELISA法的灵敏度分别为21．48％和20．0％,特异性为100％。结论ICA法和ELISA法均具有较高特异性,但其灵敏度较低。     

唾液IgG抗体测定诊断幽门螺杆菌感染

探讨唾液抗ＨｐＩｇＧ测定对Ｈｐ感染的诊断价值。方法用ＥＬＩＳＡ法测定５４例Ｈｐ阳性及１５例Ｈｐ阴性患者唾液内抗ＨＰＩｇＧ,并与血清抗体测定结果相比较。结果唾液抗ＨＰＩｇＧ对ＨＰ感染诊断的敏感性为９０．７％,特异性为８０％,准确性为８８．４％,阳性预测值９４．２％,阴性预测值７０．６％,与血清测定结果接近（分别为９２．６％,８６．７％,９１．３％,９６．ｌ％和７６．５％）,唾液ＨｐＩｇＧ与血清内ＨｐＩｇＧ滴度显著正相关（ｒ＝０．６７３７,Ｐ＜０．００１）。结论唾液ＨｐＩｇＧ测定诊断Ｈｐ感染有较好应用价值。     

Comparison of the Brucella Standard Agglutination Test with the ELISA IgG and IgM in patients with Brucella bacteremia

The presumptive diagnosis of Brucellosis is based on a high or rising antibody titer measured by the Brucella Standard Agglutination Test (SAT). This tests does not discriminate between the immunoglobulin classes (IgG and IgM). The purpose of this study was to compare the diagnostic value of SAT with Brucella Enzyme Linked Immunosorbent Assay (ELISA) IgG and IgM tests in patients with Brucella bacteremia. Over a one-year period, we had 68 patients with clinical features suggestive of Brucellosis who had positive blood cultures for Brucella species. Sera were obtained from all of the patients as well as a control group of 70 healthy military personnel who were blood donors and had no symptoms of Brucellosis. Patients and blood donors originated from the same referral population. All the sera were tested by SAT and ELISA. All the 70 controls had a negative SAT. The sensitivity and specificity of the SAT test for the bacteremic patients were 95.6% and 100.0% respectively, while that of the ELISA IgG were 45.6% and 97.1%, and that of the ELISA IgM were 79.1% and 100.0% respectively. The sensitivity and specificity of either IgG or IgM positivity were 94.1% and 97.1% respectively. Assuming that the population prevalence of active Brucellosis in Saudi Arabia (SAT >or=1:320) is 5%, the positive and negative predictive values of SAT were 100% and 99.7% respectively; of ELISA IgG they were 45.2% and 97.1%; and of ELISA IgM they were 100% and 98.9%. When both the ELISA IgG and IgM were combined, the positive and negative predictive values were 63% and 99.6% respectively. In patients with Brucella bactremia, the sensitivity of either ELISA IgM or IgG were lower than SAT, however, combining IgM and IgG had similar sensitivity and specificity to SAT. The positive predictive value of SAT and IgM is satisfactory.     

Indirect fluorescent antibody test versus enzyme-linked immunosorbent assay and agglutination tests in the serodiagnosis of patients with brucellosis

Anti-Brucella IgG, IgM and IgA in sera from patients with blood culture positive for B. melitensis and controls were measured by indirect fluorescent antibody (IFA) test and the findings compared with those of enzyme-linked immunosorbent assay (ELISA) and microagglutination test (MAT). Brucella melitensis and B. abortus antigens from three vendors (BioMerieux, Wellcome and Oxoid) and from reference strains (Ames, Iowa) were used in IFA and MAT while a whole cell heat-killed B. melitensis antigen was used in ELISA. Statistical analysis showed comparable results when using B. melitensis or B. abortus antigen, in IFA, from the same manufacturer but there were subtle differences among antigens from different manufacturers. Correlation between IFA and ELISA titers was poor, due to differences in the levels of these titers. However, the percentage of sensitivity, specificity, predictive positive, and predictive negative at different titers indicated the most reliable discriminative titers to be as follows: ELISA IgG 1 : 800 (100% for all), IgM 1 : 400 (100%, 93%, 100%, 100%, respectively) and IgA 1 : 200 (95%, 100%, 100%, 94%, respectively); IFA IgG 1 : 320 (95%, 93%, 95%, 93%, respectively) and IgM 1 : 80 (95%, 100%, 100%, 94%, respectively). IFA IgA showed either poor sensitivity or specificity at all titers. These findings and the subjective reading of IFA limit its value in Brucella diagnosis while the MAT showed high false negatives (5%–40%). Thus, ELISA proves to be the most reliable test for the diagnosis of patients with brucellosis.     

酶联免疫吸附试验检测人疱疹病毒7型抗体的研究

目的建立一种简便、快速、可靠的检测人疱疹病毒7型(HHV 7)特异性IgG和IgM酶联免疫吸附试验(ELISA)。方法应用HHV 7标准株G lasgow感染SupT1细胞,制备并纯化细胞工程抗原和重组pp85抗原;对325份血清HHV 7抗体进行检测,建立HHV 7特异性IgM和IgG间接ELISA,并与Q iagen公司ELISA试剂盒检测结果进行比较。结果采用细胞工程抗原和重组抗原制备的HHV 7 IgG和IgM ELISA诊断试剂敏感性、特异性、稳定性及重复性[变异系数(CV)<10%]较好;以Q iagen公司ELISA试剂盒为参比,重组抗原IgG ELISA检测上述标本的敏感性、特异性和符合率分别为98.1%、94.1%和97.8%,IgM ELISA分别为84.6%、99.7%和99.1%;与细胞工程抗原相比,重组抗原诊断试剂的特异性高而敏感性略低。结论自制HHV 7 IgG和IgMELISA检测试剂敏感特异,可用于临床HHV 7感染的诊断及流行病学调查。     

Trustline结核分枝杆菌IgG/IgM抗体检测试剂盒(胶体金法)的临床应用评价

目的 评价Trustline结核抗体IgG/IgM检测试剂盒临床应用效果。 方法 选用3家医院的1009份血清标本,其中628份为结核病患者血清(308例菌阳病例,320例菌阴病例);对照组381份非结核病血清。采用Trustline试剂盒及一种已上市的试剂盒(对照试剂盒)分别检测1009份血清,计算多项检测指标,从而评价试剂盒的检测效果。 结果 通过检测1009份临床血清标本, Trustline试剂盒检测血清抗体(IgG+IgM)的灵敏度、特异度、阳性预测值、阴性预测值、 Youden 指数分别为61.3%、79.8%、 83.3%、 55.6% 和0.411,对照试剂盒检测血清抗体(IgG) 的结果分别为53.7%、89.0%、88.9%、 53.8%和0.426。经统计分析表明Trustline试剂盒的灵敏度显著优于对照试剂盒(P0.01),特异度低于对照试剂盒(P0.01),但阳性诊断效率和阴性诊断效率方面差异无统计学意义,Youden指数相接近。 进一步分析显示Trustline试剂盒对菌阳样本及菌阴样本的检出率分别77.6%和44.7%,对照试剂盒则为67.9%和40.0%,对菌阳样本检出率的差异有统计学意义。检测1009份标本,Trustline试剂盒共得IgM阳性35例,其中结核组阳性30例(4.8%),非结核组阳性5例(1.3%)。 结论 Trustline试剂盒检测结核抗体的灵敏度显著优于对照结核抗体试剂盒,并可同时用于检测IgG/IgM抗体,可以应用于结核病的快速诊断。     

Evaluation of six serological tests in diagnosis and postoperative control of pulmonary hydatid disease patients

Latex agglutination (LA), passive hemagglutination (PHA), immunoelectrophoresis (IEP) and specific IgE, IgM, IgG enzyme-linked immunosorbent assay (ELISA) tests for diagnosis and postoperative follow-up of 79 patients with surgically confirmed pulmonary hydatidosis were evaluated. Specific IgG ELISA was the most sensitive test (83.5%) and the least sensitive tests were specific IgE ELISA (44.3%) and IEP (50.6%). The specificity obtained for all the serologic test was above 97% in all cases. The greatest number of false positives in all tests (except IEP) occurred in patients with Taenia saginata and Taenia solium cysticerci infestations and in patients with lymphoma and leukemia. Specific IgG ELISA demonstrated the highest negative predictive value (93.8%). No statistically significant differences (p > 0.050) were found in the sensitivity of the tests when patients with only one cyst and patients with various cysts were compared. Considering only the patients without relapse, the percentage of seropositive patients increased in all tests at 1 and 3 months after surgery. After that time the percentage of seropositive patients decreased. At 48 months after surgery all patients without relapse became negative in IEP, specific IgE ELISA, and specific IgM ELISA. The antibody titers in all seropositive patients increased during the 3 months after surgery. From these 3 months onward, antibody levels decreased in all serologic tests studied in the group of patients without relapse. The patients who had relapses during the first year after surgery presented persistently elevated antibody titers in all postoperative sera. The antibody titers of the patients who relapsed between the third and fourth years after surgery decreased progressively the third month after surgery, and increased in the serum obtained at the moment of relapse diagnosis. Our results show that persistence of elevated antibody titers in patients with pulmonary hydatidosis in the year after surgery or titer increase after a progressive decrease are indicative of relapse or reinfection.     

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。