基于ROC曲线调整献血者ALT阈值的探索性研究  

ALT threshold of blood donors under the condition of NAT-a study based on ROC curve

作　　者：谢桂芸 陈锦艳[1] 黎世杰[1] 关飞舜[1] 谭咏恩[1] 许颖莹 柯蓉蓉[1] 洪晓春[1] 汪传喜[1] XIE Guiyun;CHEN Jinyan;LI Shijie;GUAN Feishun;TAN Yongen;XU Yingying;KE Rongrong;HONG Xiaochun;WANG Chuanxi(Guangzhou Blood Center,Guangzhou 510080,China)

机构地区：[1]广州血液中心广州市医学重点实验室,广东广州510080

出　　处：《中国输血杂志》2020年第4期392-395,共4页Chinese Journal of Blood Transfusion

基　　金：广州市卫生和计划生育科技项目(805300490058);广州市医学重点学科建设项目(血液安全重点实验室)。

摘　　要：目的核酸检测条件下,基于ROC曲线对献血者ALT检测阈值进行研究,为相关政策提供参考。方法采用卡方检验分析2013年8月1日—2016年12月31日广州血液中心共1018931人次(来源于928495名献血者)献血标本中ALT和HBV/HCV NAT检测结果的相关性。以ALT值为测试变量,HBV/HCV NAT结果为状态变量绘制ROC曲线,计算约登指数获得ALT最佳阈值。随机抽样ALT值介于现有阈值与ROC曲线所得最佳阈值之间的200名ALT单项阳性献血者,半年后随访,检测其ALT、全项血清学ELISA及HBV/HCV/HIV NAT。结果8593人次ALT阳性献血标本中,8251人次(96.02%)为ALT单项阳性。ALT阳性与ALT非阳性标本的NAT单项阳性检出率无差异(P>0.05)。ROC曲线的AUC为0.61(P<0.05),约登指数最大值对应ALT阈值为89.5 U/L。半年后随机随访的200名ALT检测值介于(50—89.5)U/L的献血者,无1例HBsAg,抗-HCV,HBV DNA或HCV RNA呈阳性。结论现有检测条件下,建议适当上调献血者ALT检测阈值上限以保障血液安全性的同时减少血液的浪费。Objective To study the ALT reference range based on the ROC curve under the condition of nucleic acid detection,and provide references for relevant policies.Methods Chi-square test was used to analyze the correlation between ALT and HBV/HCV NAT in a total of 1018931 blood donations(derived from 928495 donors)from August 1st,2013 to December 31,2016 in Guangzhou Blood Center.With ALT value(test variable)and NAT results(state variable),the ROC curve was drawn to calculate the Yoden index and obtain the optimal thresholdofALT.200 ALT single-agent positive donors with ALT values between the current threshold and the threshold achieved on the ROC curve were randomly selected to follow up after half a year to test ALT,HBsAg,anti-HCV and HBV/HCV RNA.Results 8251(96.02%)in 8593 ALT reactive blood donations were positive for ALT single-agent.There was no significant difference in the rate of NAT detection between ALT-reactive and ALT non-reactive blood donations(P>0.05).The AUC of the ROC curve was 0.61(P<0.05),the optimal ALT threshold under the maximum Yoden index was 89.5 U/L.After 6 months,randomized follow-up of 200 blood donors with ALT in 50—89.5 U/L showed 0 reactive in HBsAg,anti-HCV,or HBV/HCV RNA.Conclusion Under the current national situation and testing condition,upper limit threshold of ALT in blood donors could be increased to 89.5 U/L,which could balance blood safety and availability.

关 键 词：ALT 阈值 核酸检测 ROC曲线 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]