抗核抗体间接免疫荧光试剂盒一致性评估  

Consistency evaluation of antinuclear antibody indirect immunofluorescence kit

作　　者：郜秀盼 陈兆行 曾俊祥 高莉梅 余悠悠[1] 潘秀军[1] GAO Xiupan;CHEN Zhaoxing;ZENG Junxiang;GAO Limei;YU Youyou;PAN Xiujun(Department of Clinical Laboratory,Xinhua Hospital,Shanghai Jiaotong University School of Medicine,Shanghai 200092,China;College of Medical and Dental Science,University of Birmingham,Birmingham,UK)

机构地区：[1]上海交通大学医学院附属新华医院检验科,上海200092 [2]伯明翰大学医学与牙科科学学院,伯明翰,英国

出　　处：《临床检验杂志》2024年第11期816-820,共5页Chinese Journal of Clinical Laboratory Science

摘　　要：目的评估4种常见的HEp-2间接免疫荧光法(IFA)试剂盒检测抗核抗体(ANA)相关风湿免疫病(AARD)患者和非自身免疫性疾病(NAD)患者样本的一致性。方法实验分为2个阶段。阶段1随机抽取134例2023年1月至6月在上海交通大学医学院附属新华医院进行IFA检测ANA的患者血清样本,使用4种试剂盒检测并评估定性结果,其中阳性率最高的定义为试剂X;阶段2选择在同期患者的样本中经试剂X初筛后结果为阳性的共计554例样本(218例AARD、336例NAD),再使用其他3个HEp-2 IFA试剂盒检测,记录核型和滴度,并建立半定量评分体系,评估ANA核型的重现性及不同临床性质、不同荧光强度、不同阳性反应部位下结果的一致性。结果4种试剂盒的定性结果间差异无统计学意义(P>0.05),其中m试剂的阳性率最高(45.86%),作为初筛试剂X。ANA核型重现性存在显著差异,其中着丝点型、颗粒型重现性优于均质型、致密颗粒型、核浆混合型和其他混合型(P<0.05)。单纯核型的重现性优于混合核型(P<0.05)。在核质部位,AARD组一致性评分高于NAD组(P<0.01)。各反应部位的一致性评分均随着反应强度的增强而增加,在核质、核仁、赤道板3个反应部位中,弱荧光强度和强荧光强度间差异均有统计学意义(P<0.001),胞质部位一致性评分最低。结论临床在解读IFA ANA报告时,对弱荧光强度、混合核型、胞质部位阳性的结果应更加谨慎。实验室在选择试剂时应注意抗人免疫球蛋白对结果的影响。制定HEp-2 IFA试剂盒制造的标准化官方指南可能是提高一致性、促进结果互认的关键举措。Objective To evaluate the agreement of four common HEp-2 indirect immunofluorescence assay(IFA)kits in the patients with antinuclear antibody(ANA)-associated rheumatic immune diseases(AARD)and the patients with non-autoimmune diseases(NAD).Methods The experiment in this study included two stages.In stage 1,the serum samples were randomly selected from 134 patients,and ANAs were detected by IFA at Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from January to June 2023.All of the samples were tested using four kinds of HEp-2 IFA kits,and the consistency of qualitative results was evaluated by statistical analysis.The kit exhibited highest positive rate was defined as Kit X.In the stageⅡ,a total of 554 serum samples(from 218 AARD and 336 NAD patients)with positive results detected by initial screening of reagent X were selected during the same period,and then the samples were tested by the other three HEp-2 IFA kits.The patterns and titers of ANA were recorded,and a semi-quantitative evaluation system was established.The reproducibility of different patterns of ANA and the consistency of the results among varying clinical characteristics,fluorescence reaction intensities and positive reaction sites in nucleus was statistically analyzed.Results There were no significant differences of qualitative results among the results from four kits(P>0.05).The highest positive rate appeared in the kit m(45.86%)which was deemed as the initial screening kit X.Significant differences in the consistency of ANA patterns were observed.The reproducibility scores of centromeric pattern and granular pattern were higher than those of homogeneous pattern,dense fine speckled pattern,nuclear cytoplasmic mixed pattern and other mixed pattern with significant difference(P<0.05).The reproducibility score of simple pattern was higher than that of mixed patterns(P<0.05).In the nucleoplasmic region,the consistency score of the AARD group was higher than that of NAD group(P<0.01).The consistency scores of each rea

关 键 词：抗核抗体 自身免疫性疾病 间接免疫荧光法 

分 类 号：R446.6[医药卫生—诊断学]