3种不同方法全自动自身抗体分析仪检测抗核抗体谱结果分析  

Analysis of the results of antinuclear antibody spectrum detected by three different methods of automatic autoantibody analyzer

作　　者：李季青[1] 江超[1] 段聪聪 王涛[1,2] 谢长好 侯传云[1] 李志军 LI Jiqing;JIANG Chao;DUAN Congcong;WANG Tao;XIE Changhao;HOU Chuanyun;LI Zhijun(Department of Rheumatology and Immunology,the First Affiliated Hospital of Bengbu Medical College,Bengbu 233000,Anhui,China;Anhui Province Key Laboratory of Immunology in Chronic Diseases,Bengbu 233000,Anhui,China)

机构地区：[1]蚌埠医学院第一附属医院风湿免疫科,安徽蚌埠233000 [2]慢性疾病免疫学基础与临床安徽省重点实验室,安徽蚌埠233000

出　　处：《中国现代医生》2023年第17期6-10,共5页China Modern Doctor

基　　金：安徽省高等学校省级质量工程项目(2019mooc589);蚌埠医学院科研计划项目(2020byzd060)。

摘　　要：目的探究临床常用的3种不同方法全自动自身抗体分析仪检测抗核抗体谱结果的差异。方法选取2021年4月至5月在蚌埠医学院第一附属医院确诊为系统性自身免疫病(autoimmune disease,AID)的患者72例作为AID组,留取患者相关项目检测剩余的血清样本72份,同时按照性别相同、年龄相近的原则,选取同期体检无AID的31例健康者作为对照组,留取血清样本31份。采用目前临床常用的进口全自动流式点阵发光免疫分析仪(方法A)、国产全自动流式荧光发光分析仪(方法B)和多重液相芯片免疫分析仪(方法C)分别检测两组患者血清样本中的10种抗核抗体,比较3种方法的检测阳性率,分析其阳性符合率、阴性符合率、敏感度、特异性等。为了帮助选择出对临床检验更可靠的方法学及检验设备,对3种方法进行两两比较,进行一致性评价。结果方法A、B和C与间接免疫荧光法检测的AID组阳性检出率均显著高于对照组(P<0.05)。采用方法A、B和C检测对照组10种抗体的结果均为阴性,AID组10种抗体检测结果中,方法B、C检测抗Sm抗体和抗SSA60抗体的阳性率均显著低于方法A(P<0.05),3种方法检测的其他抗体阳性率比较,差异均无统计学意义(P>0.05)。在方法A与方法B的一致性分析中,二者的平均符合率为92.22%,有1项一致性差,3项一致性一般,6项一致性好;方法A与方法C的一致性分析中,二者的平均符合率为93.89%,有5项一致性一般,5项一致性好;方法B与方法的一致性分析中,二者的平均符合率为92.65%。有1项一致性差,4项一致性一般,5项一致性好。结论目前两种国产品牌的全自动流式荧光发光分析仪和多重液相芯片免疫分析仪与进口全自动流式点阵发光免疫分析仪检测自身抗体总符合率较高,但是检测血清抗Sm抗体的一致性较差,应密切结合临床与其他实验室指标综合判断。Objective To investigate the differences in the results of the antinuclear antibody(ANA)spectrum of the three different methods of automatic autoantibody analyzer commonly used in clinical practice.Methods A total of 72 patients diagnosed with systemic autoimmune disease(AID)in the First Affiliated Hospital of Bengbu Medical College from April to May 2021 were selected as the AID group,and 72 serum samples remaining from the patients’relevant tests were retained,while 31 healthy individuals without AID in the same period of physical examination were selected as the control group according to the principle of same gender and similar age,and 31 serum samples were retained.The imported automatic flow-type lattice luminescence immunoanalyzer(method A),domestic automatic flow-type fluorescence analyzer(method B)and multiple liquid phase chip immunoanalyzer(method C)were used to detect 10 antinuclear antibodies in the serum samples of two groups of patients.The positive detection rates of the three methods were compared,and their positive compliance,negative compliance,sensitivity and specificity were analyzed.In order to help select methodologies and test equipment that are more reliable for clinical testing,a two-by-two comparison of the three methods was conducted for consistency evaluation.Results The positive detection rate of the AID group by methods A,B and C and indirect immunofluorescence were significantly higher than those of the control group(P<0.05).The results of the 10 antibodies detected in the control group by methods A,B and C were all negative.Among the 10 antibodies detected in the AID group,the positive detection rates of anti-Sm antibody and anti-SSA60 antibody by methods B and C were significantly lower than those of method A(P<0.05),and the differences were not statistically significant when comparing the positive rates of other antibodies detected by the 3 methods(P>0.05).In the concordance analysis between method A and method B,the mean concordance rate between the two was 92.22%,with one po

关 键 词：自身免疫病 抗核抗体 抗核抗体谱 多重微球流式荧光免疫技术 多重液相芯片免疫分析技术 

分 类 号：R466.11[医药卫生—临床医学]