新型戊型肝炎诊断试剂盒的研制及其应用

Preparation and Application of the New Type Hepatitis E Virus Diagnostic Kit

用ＨＥＶＯＲＦ３合成肽及ＯＲＦ２重组抗原研制成新型ＨＥＶＥＩＡ诊断试剂盒。与ＧｅｎｌａｂｓＨＥＶＥＩＡ检测比较，灵敏度和特异性均达１００％（６０／６０）。三批试剂精密性测定均＜１０％。该试剂盒置４℃８个月或３７℃４ｄ保持稳定。检测不同肝炎患者ＨＥＶ抗体，发现急性非甲非乙非丙肝炎中有６３．２％，甲肝有１３．４％，乙肝有８．３％，丙肝有６．６％，正常人群为２．９％。所研制的戊型肝炎诊断试剂盒，灵敏度高，特异性强，精密性好，稳定性合格。

Solid phase enzyme immunoassay (EIA) kit was developed for detecting anti HEV IgG by using synthetic peptide from the open reading frame (ORF)3 and recombinant antigens from ORE2.When the kit was applied to detect HEV antibodies in sera of clinical patients the results were quite consistent with the HEV diagnostic kit from Genlabs.The consistent rate reached 100%(60/60).CV of three lot kit was less than 10%.The kit was stable for 8 months at 4℃or for 4 days at 37℃.The kit was used to detect anti HEV IgG among clinically different patients with acute Non A,Non B,Non C hepatitis,Hepatitis A,Hepatitis B,Hepatitis C and normal human group,the positive rates were 63.2%,13.4%,8.3%,6.6%,2.9%, respectively. The date indicated that the HEV EIA kit is sensitive,specificic and stable,may be used to detect antibody of Hepatitis E Virus among patients and normal human group.