两种戊型肝炎IgM抗体诊断试剂的比较

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

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HEVRNA。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），）（2=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（Χ^2=0．16，P〉0．05）。HEVRNA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（Χ^2=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（Χ^2=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（Χ^2=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。

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）, Wantal-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）, Χ^2 = 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） （Χ^2 = 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 ）, Χ^2 = 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（ Χ^2 = 4. 0,P 〈0.05 ）. The specificity of Wantai-IgM was higher than MP-IgM [ 100.00% （ 202/202 ） vs 89. 11% （ 180/202 ）, Χ^2 = 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.