基于连续监测法快速检测HBsAg  

Rapid detection of HBsAg based on continuous monitoring method

作　　者：陈明心[1] 王炜[1] 张岱[1] 任伟宏[1] CHEN Mingxin;WANG Wei;ZHANG Dai;REN Weihong(Department of Laboratory Medicine,the First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou 450000,Henan,China)

机构地区：[1]河南中医药大学第一附属医院检验科,郑州450000

出　　处：《临床检验杂志》2022年第5期321-325,共5页Chinese Journal of Clinical Laboratory Science

基　　金：河南省中医药科学研究专项课题(2019JDZX2077)。

摘　　要：目的建立乙型肝炎病毒表面抗原(HBsAg)定性测定的快速连续监测法。方法摸索均相光激化学发光免疫分析技术检测HBsAg的反应时间条件,建立短时连续检测程序。使用分类回归树(CART)算法,根据10个组合分类变量建立阴阳性判断规则,同时根据阴性、阳性样本重叠区域,建立可疑判断规则。对连续监测法进行检出限验证,并比较连续监测法和第1次读数的阴性复检率。结果确定均相光激化学发光免疫分析技术检测HBsAg的2次温育时间分别为9 min、4 min,之后每分钟检测1次,连续3次,总反应时间为15 min。采用CART决策树建立了判断规则,在该规则下,样本验证阴性符合率为100%,阳性符合率为97.5%。训练样本风险指数为0.02,验证样本风险指数为0.011,均小于0.05。连续监测法在0.1 IU/mL时检出限验证符合要求。连续监测法的阴性复检率为2.55%,第1次读数方案的阴性复检率为7.64%,两者差异有统计学意义(χ^(2)=4.215,P=0.04)。结论连续监测法在满足定性准确性和低复检率要求下可缩短反应时间。Objective To establish a rapid continuous monitoring method for qualitative determination of hepatitis B virus surface antigen(HBsAg).Methods A rapid continuous detection program was established though exploring the conditions of reaction time for HBsAg test by amplified luminescent proximity homogeneous assay linked immunosorbent assay.The judgment rules for negative and positive samples were established by using the Classification and Regression Tree(CART)based on 10 combinatorial classification variables.The judgment rules for suspicious results were established simultaneously according to the overlapping areas of negative and positive samples.The detectable limit of continuous monitoring method was verified,and the retest rates for negative results in continuous monitoring method and the first reading were compared.Results The incubation times for HBsAg detection of by amplified luminescent proximity homogeneous assay linked immunosorbent assay were determined to be 9 and 4 min in two tests,respectively.The detections were performed once per minute for 3 consecutive times with 15 minutes of the final total reaction time.The judgment rule was established according to CART,by which the negative coincidence rate of sample verification was 100%and the positive coincidence rate was 97.5%.The risk indexes were 0.02 and 0.011 for training samples and validated samples respectively,both of which were less than 0.05.The detectable limit of the continuous reading protocol was verified to meet the requirements at the concentration of 0.1 IU/mL.The negative retest rate of the continuous monitoring method was 2.55%,which was significantly different from the retest rate of 7.64%in the first reading value protocol(χ^(2)=4.215,P=0.04).Conclusion The reaction time was shortened by continuous monitoring method,and the requirements of both qualitative accuracy and low retest rate were satisfied.

关 键 词：乙型肝炎病毒表面抗原 连续读数法 分类回归树 

分 类 号：R446.6[医药卫生—诊断学]