三种方法检测低浓度乙肝表面抗原的比较与分析

Comparison and Analysis of Three Methods in Testing Low Concentration HBsAg Samples

目的：初步探讨三种方法对低浓度乙肝表面抗原（HBsAg）定性与定量检测的结果并进行对比分析。方法分别用酶联免疫吸附法（ELISA）、化学发光微粒子免疫分析法（CMIA）与时间分辨荧光免疫法（TRFIA）测定2013年10月～2014年4月间于湖南旺旺医院就诊及体检的85例低浓度 HBsAg（ELISA法0.6＜S／CO≤3.0）标本，三种方法测定低浓度 HBsAg定性结果分为0.6＜S／CO≤1.0，0.6＜S／CO≤3.0两组采用检出阳性率进行χ2检验；HBsAg定量结果分为0.6＜S／CO≤1.0，1.0＜S／CO≤2.0，2.0＜S／CO≤3.0，0.6＜S／CO≤3.0四组采用配对样本t检验进行两两比较；HBsAg含量相关性采用相关系数t检验进行两两分析。结果①HBsAg检出阳性率0.6＜S／CO≤1.0组 CMIA法（64.0％）和TRFIA法（54.0％）两者之间差异无统计学意义（χ2值为0.333，P＞0.05），0.6＜S／CO≤3.0组 ELISA 法（70.6％）与CMIA法（89.4％）及TRFIA法（87.1％）之间差异有统计学意义（χ2值分别为9.412，6.907，P均＜0.05），CMIA法和TR-FIA法两者之间差异无统计学意义（χ2值为0.227，P＞0.05）。HBsAg检出阳性率 CMIA＞TRFIA＞ELISA。②HBsAg含量测定0.6＜S／CO≤1.0，1.0＜S／CO≤2.0，2.0＜S／CO≤3.0三组除在2.0＜S／CO≤3.0组 ELISA法与 CMIA法之间，ELISA法与TRFIA法之间差异均有统计学意义（t值1.743～3.671，P均＜0.05），0.6＜S／CO≤3.0组三种方法之间差异均有统计学意义（t值分别为2.053，2.766，4.459，P均＜0.05），总体含量CMIA＞TRFIA＞ELISA。③三种方法测定HBsAg含量之间均呈正相关关系（t值分别为2.928，2.939，60.915，P均＜0.05），其中 CMIA法与 TRFIA法之间相关性最好（r＝0.989）。结论低浓度 HBsAg检测应首选 CMIA法，TRFIA法次之。对于 ELISA法检测低浓度 HBsAg标本应向临床建议用CMIA法或TRFIA法复查，避免漏检；并且不建议临床对不同方法测定定量或半定量结果间进行横向比较，避免误诊。

Objective To make a preliminary study on the results from qualitative and quantitative detection of low concentra-tion hepatitis B surface antigen（HBsAg）.Methods 85 HBsAg low concentration serum samples （ELISA method test re-sults were 0.6〈S/CO≤3.0）,which collected in Hunan Wantwant Hospital from 2013 October to 2014 April,were retested by chemilumiescence microparticle immunoassay （CMIA）and time-resovled fluorescence immunoassay （TRFIA）methods at the same time respectively.The derermination of low concentration HBsAg positive rates of the three methods were divided into 0.6〈S/CO≤1.0,0.6〈S/CO≤3.0 two groups using chi-square test.The pairwise comparison of HBsAg contens of the three methods were divided into 0.6〈S/CO≤1.0,1.0〈S/CO≤2.0,2.0〈S/CO≤3.0,0.6〈S/CO≤3.0 four groups using paired-samples t test.Adopted correlation coefficient t test in the analysis of the correlation of three different methods test results.Results ①The positive detection rate showed no statistically difference between CMIA （64.0%,89.4%）and TRFIA （54.0%,87.1%）in 0.6〈S/CO≤1.0 group （χ2=0.333,P〉0.05）and 0.6〈S/CO≤3.0 group （χ2=0.227,P〉0.05）.The positive detection rate showed statistically difference between ELISA （70.6%）and CMIA,TRFIA in 0.6〈S/CO≤3.0 group （χ2=9.412,6.907,P〈0.05）.The positive detection rate was CMIA〉TRFIA〉ELISA.②The contents of HBsAg showed statistically difference among 0.6〈S/CO≤1.0,1.0〈S/CO≤2.0,2.0〈S/CO≤3.0 three groups in addi-tion to between 2.0〈S/CO≤3.0 group of ELISA and CMIA,ELISA and TRFIA （t=1.743~3.671,P〈0.05）.The con-tents of HBsAg showed statistically difference among 0.6〈S/CO≤3.0 group （t=2.053,2.766,4.459,P〈0.05）.The con-tent was CMIA〉TRFIA〉ELISA.③There was a positive correlation between the three methods of HBsAg content （t=2.939,2.928,60.915,P〈0.05）.The correlation between CMIA method and TRFIA method was the best （r=0.989）.Con-clusion CMIA was the first choice for testing low concentration HBsAg,TRFIA was the second.For the specimens of the low concentration HBsAg detected by ELISA should be suggested to clinical and retested by CMIA or TRFIA in order to a-void missing detection.And it was not recommended to clinical that different methods of quantitative or half-quantitative re-sults were transverse compared in order to avoid misdiagnosis.