596例HBsAg低值血清样本确诊试验的结果分析

Analysis on confirmatory test results of 596 cases of HBsAg low value serum samples

目的通过对HBsAg低值血清样本确诊试验的结果分析,为临床合理评价和解释HBsAg低值结果提供依据。方法对2014年川北医学院附属医院HBsAg阳性结果进行回顾性分析,收集化学发光法（CMIA）检测HBsAg结果为0.05-1.00IU/mL的低值血清样本596份,采用雅培Architect HBsAg确诊试剂盒对其进行检测。结果 HBsAg低值样本占HBsAg阳性样本的12.59%。雅培HBsAg确诊试验的总阳性率为72.15%,其中0.05-0.10、〉0.10-0.20、〉0.20-1.00IU/mL的确诊阳性率分别为11.25%、88.35%、100.00%,各水平确诊阳性率比较差异有统计学意义（χ2=410.98,P〈0.01）。CLIA方法检测HBsAg血清样本的＂可疑区间＂为0.08-0.14IU/mL。在不同年龄阶段的HBsAg阳性样本中,〈1岁年龄阶段人群在0.05-0.14IU/mL的检出率最高,达90.60%（135/149）。结论 CLIA方法检测HBsAg时存在一定的假阳性,尤其应注意小于1岁年龄阶段人群的HBsAg的低值结果的评价和解释。

Objective To analyze the confirmatory test results of low HBsAg value serum samples to provide the basis for clinical rational evaluation and explanation of low HBsAg value results.Methods The HBsAg positive results in the Affiliated Hospital of North Sichuan Medical College during 2014 were performed the retrospective analysis.596 serum samples with the HBsAg results of 0.05-1.00IU/mL by the chemiluminiscence immunoassay（CLIA）were collected and then detected by the Abbott Architect HBsAg confirmatory kit.Results The low HBsAg value samples accounted for 12.59% of HBsAg positive samples.The total positive rate of Abbott Architect HBsAg confirmatory test was 72.15%,in which the positive rates of 0.05-0.10IU/mL,0.10-0.20IU/mL and0.20-1.00IU/mL were 11.25%,88.35%and 100.00%,respectively,the differences among different levels were statistically significant（χ2=410.98,P〈0.01）.The suspicious range of HBsAg detected by CLIA was 0.08-0.14IU/mL.In different ages of the HBsAg positive samples,the detection rate of 0.05-0.14IU/mL in the1year old group was highest and reached 90.60%（135/149）.Conclusion Certain false positive exists in CLIA for detecting HBsAg,especially the evaluation and explanation of HBsAg low value results in the age group of1year old should be paid attention to.