一起戊型肝炎暴发的血清抗体比较研究

目的评价戊型肝炎(戊肝)抗体E2-IgM(抗-HEV E2-IgM)酶联免疫试剂(捕获法)在反映戊肝流行特征和对戊肝早期诊断中的作用.方法在首发病例26 d后对某单位戊肝暴发人群和相邻单位对照人群进行血清抗-HEV E2-IgM、IgG检测;部分人群进行美国Genelabs抗-HEV IgM、IgG的平行检测.结果抗-HEV E2-IgM试剂捕获法在对照人群中仅检出1例阳性(0.11%),且阳性和阴性之间可明显区分,其特异度为99.89%;在暴发流行人群中检出145例阳性(8.66%),显著高于对照人群(P＜0.001);暴发人群中戊肝患者的血清学动态变化为抗-HEV E2-IgM在暴露时间为30～60d时保持较高吸光度(A值),随着时间的延长A值呈明显下降趋势;抗-HEV E2-IgM阳性在该组人群中与性别和年龄无关;在暴发人群抗-HEV E2-IgM(+)的115例患者中,Genelabs抗-HEV IgG检测出88份阳性,检出率为76.52%,漏检27例,漏检率为23.48%.对照人群随机抽样179例患者中有20例Genelabs抗-HEVI IgG(+),阳性率为11.17%.在110份抗-HEV E2-IgM(+)的血样中,Genelabs抗-HEVIgM只检测出76份,检出率为69.09%;有16例患者Genelabs抗-HEV IgG、IgM均未能检出;Genelabs抗-HEV IgG和IgM的不一致率为25.45%.结论抗-HEV E2-IgM具有99%左右的特异度,与在正常人群中检出较高阳性率的Genelabs抗-HEV IgG试剂相比,减少了假阳性;抗-HEV E2-IgM与Genelabs抗-HEV IgM、IgG相比,对急性戊肝感染诊断的灵敏度提高了25%～30%,减少了漏诊;抗-HEV E2-IgM试剂盒操作简单、快速,本底较好,不存在酶结合物不足的问题.

Serological antibodies comparison of a hepatitis E outbreak

OBJECTIVE: To compare the serological characters of an outbreak of hepatitis E and evaluate sensitivity and specificity of anti-HEV E2-IgM. METHODS: The sera collected from the employees of an outbreak unit were detected for anti-HEV E2-IgM and IgG, and the serum samples from a neighboring department were used as control. The results detected with anti-HEV E2-IgM, IgG and Genelab anti-HEV IgM, IgG in some samples were compared. RESULTS: The positive rate of anti-HEV E2-IgM in the control group was 0.11%. The results between the positive and the negative samples can be distinguished easily. The specificity of anti-HEV E2-IgM is about 99.89%. The positive rate of anti-HEV E2-IgM in outbreak stricken population was 8.66%, significantly higher than that in the control group (P < 0.001). The results from HEV patients' serial samples in the outbreak unit showed that the anti-HEV E2-IgM titer was high 30-60 days after the infected and then declined clearly. The positivity seemed unrelated to neither sex nor age. Among the 115 positive to anti-HEV E2-IgM, 27 were negative to Genelab anti-HEV IgG, the fact indicated a rather high risk of misdiagnosis of about 23.48%. In the 179 randomized samples of the control group, the positive rate of Genelabs anti-HEV IgG was about 11.17%. In 110 samples for the positive anti-HEV E2-IgM, the positive ratio of Genelabs anti-HEV IgG was about 76.36%, and that of Genelabs anti-HEV IgM only 69.09%. There were 16 samples negative for both Genelabs anti-HEV IgG and IgM. The ratio of the difference between the Genelabs anti-HEV IgG and IgM was about 25.45%. CONCLUSION: The specificity of anti-HEV E2-IgM was about 99%, and false positive rate was low. The sensitivity of anti-HEV E2-IgM in acute hepatitis E infection was 25%-30% higher than that of Genelabs anti-HEV IgM,IgG. The infected persons in the outbreak unit can be preferably distinguished from the non-infected persons by anti-HEV E2-IgM. Anti-HEV E2-IgM can image the characters of the outbreak of HEV and played a great role in the control of outbreak and in the early diagnosis for hepatitis E.