采用液相芯片技术检测肾移植术前致敏受者抗HLA抗体的初筛漏检情况分析  

The miss rate analysis of anti-HLA antibodies detection for kidney transplantation preoperative recipients with sensitization history based on luminex xMAP

作　　者：代波[1] 庄杰[1] 巫丽娟[1] 林涛[1] 王莉[1] Dai Bo;Zhuang Jie;Wu Lijuan;Lin Tao;Wang Li.(West China Hospital of Sichuan University, Chengdu 610041, China)

机构地区：[1]四川大学华西医院,成都610041

出　　处：《中华器官移植杂志》2018年第2期81-86,共6页Chinese Journal of Organ Transplantation

摘　　要：目的探讨采用液相芯片技术的两种方法检测抗HLA抗体，比较两者检出率的差异，并分析初筛的漏检情况。方法收集2015年9月至2016年4月214例肾移植术前有致敏史受者的血清样本，经Luminex xMAP平台应用混合抗原试剂（初筛试剂）LABScreen Mixed（LM）和单一抗原试剂（特异性检测试剂）LABSreen Single Antigen（LSA）检测抗HLA抗体。结果LM法检测抗HLA-Ⅰ类抗体和抗HLA-Ⅱ类抗体的阳性率分别为50.9%和23.4%，LSA法检测阳性率分别为58.9%和46.7%，LM法检测抗HLA抗体的阳性率低于LSA法，且差异均具有统计学意义（P〈0.05）。LM法检测抗HLA-Ⅰ类抗体的灵敏度为80.2%，特异度为90.9%，漏检率为19.8%，误检率为9.1%，漏检频率最高的是Cw＊17：01、B＊15：12和B＊45：01，最高平均荧光强度（MFI）值为10603；检测抗HLA-Ⅱ类抗体的灵敏度为49.0%，特异度为99.1%，漏检率为51.0%，误检率为0.9%，漏检频率最高的是DPA1＊01：03, DPB1＊06：01和DPA1＊01：03, DPB1＊01：01，最高MFI值为3659。对于仅有输血史或妊娠史患者，两种方法检测抗HLA-Ⅰ类抗体时差异无统计学意义；而检测抗HLA-Ⅱ类抗体时的差异具有统计学意义（P〈0.05）。对于既有输血史又有妊娠史患者，LM法和LSA法检测两类抗HLA抗体的差异均无统计学意义（P〉0.05）。结论LM法敏感性低于LSA法，且检测抗HLA-Ⅰ类抗体的漏检率低于抗HLA-Ⅱ类抗体。临床将LM法作为诊断性初筛实验存在一定弊端，建议对于有致敏史的患者，宜采用LSA法检测抗HLA抗体，通过LSA法可为临床提供更准确的抗HLA-Ⅰ、Ⅱ类抗体信息。Objective To interrogate the detection of anti-HLA antibodies using two methods of Luminex xMAP, and to compare their detection capacity and to analyze their misdetection rate for initial screening, providing more accurate results in clinical practice.Methods 214 serum samples from recipients with a history of sensitization before renal transplantation were collected and detected by LM （LABScreen Mixed） and LSA （LABScreen Single Antigen） respectively on the Luminex xMAP platform.Results For the LM detection, the positive rates of anti-HLA class I and II were 50.9% and 23.4% respectively, which were lower than those used by the LSA detection （58.9% and 46.7% respectively）. The difference had statistical significance （P〈0.05）. The sensitivity, specificity, miss rate and mistake rate of anti-HLA class Ⅰ and Ⅱ detection were 80.2%, 90.9%, 19.8%, 9.1% and 49.0%, 99.1%, 51.0%, 0.9% respectively. The missed detection gene with the highest rate was Cw＊17： 01, B＊15： 12, B＊45： 01 for anti-HLA class I and DPA1＊01： 03, DPB1＊06： 01, DPA1＊01： 03, DPB1＊01： 01 for anti-HLA class II. The highest MFI value was 10603 and 3659. For the recipients with only blood transfusion history or pregnancy history, LM and LSA detection showed no statistically significant difference when detecting anti-HLA class I antibodies, but had statistically significant difference when testing anti-HLA class II antibodies. For the patients with history of both blood transfusion and pregnancy history, LM and LSA showed no significant difference in the detection of anti-HLA class Ⅰ antibodies and anti-HLA class Ⅱ antibodies. The miss rate of anti-HLA class I antibody detection was lower than that of anti-HLA class Ⅱ antibody detection.Conclusion LSA detection has the higher sensitivity and lower miss rate than LM detection. In the light of the disadvantage of LM detection as diagnostic preliminary screening, it is suggested that LSA detection should be used directly for the recipients with a history of

关 键 词：肾移植 抗HLA抗体 液相芯片 

分 类 号：R699.2[医药卫生—泌尿科学]