ELISA法检测乙肝标志物临床应用.docVIP

ELISA法检测乙肝标志物临床应用[摘要] 目的 探讨ELISA法检测健康体检者血清中HBsAg的临床效果。 方法 用三个不同公司生产的乙肝表面抗原（HBsAg）检测试剂盒，通过ELISA法检测220例健康体检患者血清中HBsAg水平，检测出的阳性标本再用免疫胶体金试纸条检测，比较三个不同公司生产试剂盒检测阳性率及与金标试纸条法检测的一致性。 结果 江莱、万泰、新创三家厂家生产的试剂盒检测HBsAg阳性率分别为12.3%（27/220）、9.5%（21/220）、13.6%（30/220）。新创阳性率最高。阳性血清经金标试纸条检测阳性结果分别为24、18、27例。新创试剂盒ELISA法检测抗原包被浓度为1.25 IU/L时，仍可检出阳性标本。其他两个试剂盒最低检出浓度为2.5 IU/L，差异无统计学意义（χ2=1.25，P ＞ 0.05）。 结论 不同厂家ELISA试剂盒检测结果存在差异，临床检测时需综合几个试剂盒结果及其他试验进行印证。 [关键词] ELISA法；胶体金法；乙肝；诊断 [中图分类号] R575.2 [文献标识码] A [文章编号] 1673-7210（2012）01（c）-0089-02 Clinical application of ELISA in the detection of hepatitis B markers ZHAO Liaoqun Department of Laboratory, Maternal and Child Care Service Center of Yan’an City, Shaanxi Province, Yan’an 716000, China [Abstract] Objective To evaluate the clinical efficacy of ELISA in the detection of serum hepatitis B surface antigen (HBsAg) in healthy subjects. Methods HBsAg serum levels of 220 healthy subjects were detected by ELISA method with HBsAg assay kit manufactured by three different companies and the positive samples were then tested with immune colloidal gold dipsticks. The consistency of positive rate of the assay kit manufactured by the three different companies with the gold standard test strip assay was evaluated. Results Test positive rate of the assay kits manufactured by Jianglai, Wantai and Xinchuang was 12.3% (27/220), 9.5% (21/220) and 13.6% (30/220) respectively. The gold standard test strip results were positive in 24 cases, 18 cases, 27 cases among the positive serum. Coating concentration of the assay kit manufactured by Xinchuang was 1.25 IU/L and was 2.5 IU/L for the assay kits manufactured by the other two companies, and the differences were no significant (χ2 = 1.25, P ＞ 0.05). Conclusion Test results of ELISA kits by different manufacturers are different, thus it is necessary in clinical application to confirm test results by combined use of several assay kits and other tests. [Key words] ELISA method; Colloidal gold method; Hep