两种戊型肝炎IgM抗体诊断试剂的比较

目的 比较两种戊型肝炎病毒(HEV)IgM抗体诊断试剂的可靠性.方法 用北京万泰抗HEV-IgM抗体(万泰-IgM)和新加坡MP抗HEV-IgM抗体(MP-IgM)诊断试剂、北京万泰抗HEV-IgG抗体诊断试剂检测92例健康体检者、71例可疑戊型肝炎患者、55例确诊急性戊型肝炎患者、50例类风湿因子(RF)阳性患者、54例抗甲型肝炎病毒(HAV)-IgM阳性者的相应HEV抗体.逆转录聚合酶链反应法(RT-PCR)检测部分可疑戊型肝炎患者的HEV RNA.结果 检测可疑戊型肝炎患者、急性戊型肝炎患者及健康体检者时万泰-IgM、MP-IgM符合率为73.39%(160/218),阳性率差异无统计学意义46.79%(102/218)比44.04%(96/218),χ2=0.62,P＞0.05].在检测可疑戊型肝炎患者时,万泰-IgM诊断HEV急性感染的敏感性(83.08%,54/65)比MP-IgM(78.46%,51/65)高,但差异没有统计学意义(χ2=0.16,P＞0.05).HEV RNA阳性(35例)的可疑戊型肝炎患者中,万泰-IgM检测敏感度(97.14%,34/35)也明显比MP-IgM(74.29%,26/35)高,差异有统计学意义(χ2=4.9,P＜0.05).55例确诊的急性戊型肝炎患者中,万泰-IgM的敏感度(87.27%,48/55)显著高于MP-IgM(67.27%,37/55),差异有统计学意义(χ2=4.0,P＜0.05).万泰-IgM诊断HEV急性感染的特异度(100.00%,202/202)比MP-IgM(89.11%,180/202)好,差异有统计学意义(χ2=20.05,P＜0.005).RF、抗HAV-IgM阳性时会引起MP-IgM假阳性,但不干扰万泰-IgM结果.结论 万泰-IgM试剂是良好的急性戊型肝炎诊断试剂.

Comparison of the reliability of two ELLSA kits for detecting IgM antibody against hepatitis E virus

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 pailents 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 wag analyzed with RT-PCR in 52 of 71 cages 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 observed46.79%(102/218)vs 44.04%(96/218),χ2=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)(χ2=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),χ2=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(χ2=4.0,P＜0.05).The specificity of Wantai-IgM was higher than MP-IgM100.00%(202/202)vs 89.11%(180/202),χ2=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.