[两种用于检测戊型肝炎病毒IgM抗体的酶联免疫吸附测定试剂盒可靠性的比较]

[Comparison of the reliability of two ELISA kits for detecting IgM antibody against hepatitis E virus].

作者信息

Zhou Hui, Jiang Chu-Wen, Li Lu-Ping, Zhao Chen-Yan, Wang You-Chun, Xu Yi-Wei, Chen Xue-Fu

机构信息

Department of Clinical Laboratory, Guangdong Provincial People's Hospital, Guangzhou 510080, China.

出版信息

Zhonghua Yu Fang Yi Xue Za Zhi. 2008 Sep;42(9):667-71.

PMID:19175178

Abstract

OBJECTIVE

To study the reliability of two ELISA kits for detecting IgM antibody against hepatitis E virus (HEV).

METHODS

Serum samples from 92 healthy subjects, 71 cases suspected of hepatitis E, 55 patients with confirmed diagnosis of acute hepatitis E, 50 individuals with rheumatoid factor (RF) positive and 54 persons with anti-HAV IgM positive were detected with three hepatitis E diagnostic kits. MP-IgM (MP, Singapore), Wantai-IgM and anti-HEV IgG (Wantai, China). HEV RNA was analyzed with RT-PCR in 52 of 71 cases suspected of hepatitis E.

RESULTS

In healthy subjects,cases suspected of hepatitis E and confirmed acute hepatitis E, the concordance between the two anti-HEV IgM reagents was 73.39% (160/218) and the significant differences in the positive rates of two assays were not observed [46.79% (102/218) vs 44.04% (96/218), chi2 = 0.62, P > 0.05]. Of 71 patients suspected of hepatitis E, the sensitivity for diagnosing acute hepatitis E of Wantai-IgM and MP-IgM were 83.08% (54/65) and 78.46% (51/65) (chi2 = 0.16, P > 0.05), respectively. Among those suspected of hepatitis E with HEV RNA positive, the sensitivity of Wantai-IgM was obviously higher than that of MP-IgM [(97.14%, 34/35) vs (74.29%, 26/35), chi2 = 4.9, P < 0.05]. 48 of 55 patients (87.27%) with confirmed diagnosis of hepatitis E were Wantai-IgM positive while 37 (67.27%) was MP-IgM positive (chi2 = 4.0, P < 0.05). The specificity of Wantai-IgM was higher than MP-IgM [100.00% (202/202) vs 89. 11% (180/202), chi2 = 20.05, P < 0.005]. RF and anti-HAV IgM might cause MP-IgM false positive without interference on Wantai-IgM.

CONCLUSION

Wantai-IgM should be a good ELISA kit for the diagnosis of acute hepatitis E.

摘要

目的

研究两种检测戊型肝炎病毒（HEV）IgM抗体的酶联免疫吸附测定（ELISA）试剂盒的可靠性。

方法

采用三种戊型肝炎诊断试剂盒检测92名健康受试者、71例疑似戊型肝炎患者、55例确诊急性戊型肝炎患者、50例类风湿因子（RF）阳性个体及54例抗甲型肝炎病毒（HAV）IgM阳性者的血清样本。三种试剂盒分别为MP-IgM（MP，新加坡）、万泰-IgM及抗-HEV IgG（万泰，中国）。对71例疑似戊型肝炎患者中的52例进行逆转录聚合酶链反应（RT-PCR）分析以检测HEV核糖核酸（HEV RNA）。

结果

在健康受试者、疑似戊型肝炎患者及确诊急性戊型肝炎患者中，两种抗-HEV IgM试剂的一致性为73.39%（160/218），两种检测方法的阳性率差异无统计学意义[46.79%（102/218）对44.04%（96/218），χ2 = 0.62，P > 0.05]。在71例疑似戊型肝炎患者中，万泰-IgM和MP-IgM诊断急性戊型肝炎的敏感度分别为83.08%（54/65）和78.46%（51/65）（χ2 = 0.16，P > 0.05）。在疑似戊型肝炎且HEV RNA阳性的患者中，万泰-IgM的敏感度明显高于MP-IgM[（97.14%，34/35）对（74.29%，26/35），χ2 = 4.9，P < 0.05]。55例确诊戊型肝炎患者中，48例（87.27%）万泰-IgM阳性，37例（67.27%）MP-IgM阳性（χ2 = 4.0，P < 0.05）。万泰-IgM的特异性高于MP-IgM[100.00%（202/202）对89.11%（180/202），χ2 = 20.05，P < 0.005]。RF和抗-HAV IgM可能导致MP-IgM出现假阳性，但对万泰-IgM无干扰。