CMIA与ELISA法检测慢性HBV感染者HBeAg/抗HBe双阳性现象的血清学特征和方法学差异

Serological Characteristics and Methodological Differences of HBeAg/Anti-HBe Double Positive in Patients with Chronic HBV Infection

目的研究分析慢性乙型肝炎(Chronic hepatitis B virus infection,CHB)患者检出HBeAg(+)/抗HBe(+)结果的血清学特征及其方法学差异。方法收集2019年1月~12月在西安交通大学第二附属医院感染科就诊并接受治疗、临床实验室化学发光免疫分析(CMIA)法检测乙肝病毒血清标记物结果且呈HBeAg/抗HBe双阳性的CHB病例363例。另收集酶联免疫吸附(ELISA)法检测结果呈HBeAg/抗HBe双阳性样本87例。分析HBeAg/抗HBe双阳性的CHB病例的HBV-M血清学特征和病毒学特征,并比较CMIA和ELISA法检测HBeAg/抗HBe双阳性结果之间的方法学差异。结果CMIA法检出的363例HBeAg/抗HBe双阳性样本中HBsAg阳性率98.62%,HBsAg 3~4log10 IU/ml和2~3log10 IU/ml分别占63.36%和20.11%,HBsAg<0.05 IU/ml占1.38%;抗HBs≥10mIU/ml 32例,占8.82%;HBeAg均值5.27 S/CO,1~9.99 S/CO和10~19.99 S/CO水平分别占87.88%和9.09%;抗HBe均值0.61 S/CO,≥0.10 S/CO 95.87%;HBV-DNA≥6 log10病例8.39%,HBV-DNA≥2log10病例53.28%,不同HBV-DNA水平下HBeAg和抗HBe水平存在显著性差异。87例ELISA法初检HBV-M呈HBeAg/抗HBe双阳性样本经CMIA法检测阳性率3.45%;49例CMIA法检测HBeAg/抗HBe双阳性样本的ELISA法检测阳性率4.08%。结论CHB患者HBeAg/抗HBe双阳性时HBV-M水平多样,HBV-DNA水平多样,不同方法学之间存在明显差异,ELISA法检测结果假阳性较多,建议采用CMIA法复检。

Objective To study serological characteristics and methodological differences of HBeAg/anti-HBe double positive in patients with chronic HBV infection.Methods Samples were collected from 363 CHB patients who were treated in the Department of Infection,the Second Affiliated Hospital of Xi'an Jiaotong University from January to December 2019.Another 87 HBeAg/anti HBe double positive samples were tested by ELISA and collected.HBV-M serological and virological characteristics of the 363 CHB cases were analyzed and the methodological differences between CMIA and ELISA were compared.Results Among 363 HBeAg/anti HBe double positive samples detected by CMIA,the positive rate of HBsAg was 98.62%,63.36%and 20.11%of HBsAg were 3~4log10 IU/ml and 2~3log10 IU/ml,1.38%were HBsAg<0.05 IU/ml,32 cases were anti HBs positive,accounting for 8.82%.Mean HBeAg was 5.27 S/CO,1~9.99 S/CO and 10~19.99 S/CO,respectively 88%and 9.09%,and mean anti-HBe was 0.61S/CO,≥0.10 S/CO 95.87%.HBV-DNA≥6 log10 cases 8.39%,HBV-DNA≥2 log10 cases 53.28%,HBeAg and anti HBe levels were significantly different in different HBV-DNA levels.Among 87 HBeAg/anti-HBe samples detected by ELISA the HBeAg/anti-HBe rate by CMIA was 3.45%and among 49 HBeAg/anti-HBe samples detected by CMIA the rate of ELISA was only 4.08%.Conclusion The levels of HBV-M and HBV-DNA in CHB patients with double positive HBeAg/anti HBe were diverse,and there were significant differences among different methods.The results of ELISA were more false positive,so CMIA method was recommended for reexamination.