多抗原组合筛查试剂筛查自身免疫性肝病的临床意义

Analysis of clinical significance of combined antigen screening reagents for autoimmune liver disease

目的探讨自身免疫性肝病多抗原组合筛查试剂的临床意义。方法选择2011年9月至2012年9月在首都医科大学附属北京佑安医院就诊的肝病患者140例,健康献血员30例,PBC患者家属8例。分别应用筛查试剂(ELISA)法(以AMA-M2、sp100、gp210、LKM-1、SLA/LP为混合靶抗原)、常规检测项目包括间接免疫荧光法(IFA)、免疫印迹法(IBT)、AMA-M2 ELISA法检测178例血清样本。组间比较采用χ2检验。结果 178例样本,应用筛查试剂检测阳性70例(50%),强阳性49例。70例阳性样本采用常规试剂进一步检测自身抗体,IFA检测抗核抗体(ANA)阳性61例,AMA阳性63例。其中61例ANA阳性样本中21例荧光核型为核膜型,但IBT检测抗gp210抗体16例为阳性,5例为阴性。63例AMA阳性样本,应用AMA-M2 ELISA法检测AMA-M2 60例为阳性,3例为阴性。49例强阳性样本应用常规检测,其中抗gp210抗体单独阳性2例、抗sp100抗体单独阳性5例、AMA-M2单独阳性20例、抗gp210抗体和AMA-M2同时阳性12例、抗sp100抗体和AMA-M2同时阳性10例。178例样本中,65例PBC患者采用常规检测均可检出PBC相关抗体,而采用筛查试剂检测则63例PBC患者阳性,2例为阴性,符合率为96.9%(63/65),常规试剂检出例数高于筛查试剂检出例数,但二者差异无统计学意义(χ2=0.016,P>0.05)。4例样本采用筛查试剂检测为阳性而常规试剂检测各单一自身抗体均为阴性。结论自身免疫性肝病多抗原组合筛查试剂筛查自身免疫性肝病有较高的敏感性、特异性,具有操作简便、快速、低成本的特点。可应用于自身免疫性肝病的初步筛查。

Objective To investigate the clinical significance of combined antigen screening reagents for autoimmune liver disease （AILD）. Methods A total of 140 patients with liver diseases who visited the Beijing You′an Hospital affiliated to Capital Medical University from September 201 1 to September 2012,as well as 30 healthy blood donors and 8 relatives of patients with primary biliary cirrhosis （PBC）,were included in the study.The serum samples from the 178 subjects were tested by enzyme-linked immunosorbent assay （ELISA）for detection of AMA-M2,anti-sp100 antibodies,anti -gp210 antibodies,anti -LKM-1 antibodies,and anti -SLA/LP antibodies,as well as indirect immunofluorescence assay （IFA）for autoantibodies,immunoblotting （IB）for antibody profiles,and AMA-M2 ELISA.Results Of the 140 patients tested by screening reagents,70 （50%）had positive results,and 49 of them had strong positive results.Of the 70 positive cases, 61 were positive for ANA and 63 were positive for AMA,as shown by IFA;21 of the 61 ANA-positive cases had a rim pattern of staining. The IB showed that 16 cases were positive for anti-gp210 antibodies,and 5 cases were negative.The AMA-M2 ELISA showed that 60 of the 63 AMA-positive cases were positive for AMA-M2.Of the 49 strong positive cases,2 were positive for anti-gp210 antibodies,5 for anti-sp100 antibodies,20 for AMA-M2,12 for both anti-gp210 antibodies and AMA-M2,and 10 for both anti-sp100 antibodies and AMA-M2,as shown by conventional tests.Among the 178 subjects,all the 65 PBC patients were positive for PBC-related antibodies by conventional tests,while 63 of these PBC cases had positive results using the screening reagents,with a coincidence rate of 96.9%（63/65）;the number of positive cases detected using conventional reagents was insignificantly higher that determined by screening reagents（χ^2 =0.016, P〉0.05）.Four cases tested positive for autoantibodies using screening reagents,but had negative results using conventional reagents.Conclusion The combined antigen screening reagents for AILD have the advantages of high sensitivity,high specificity,easy operation, high efficiency,and low cost,and they can be used in the preliminary screening for AILD.