胶体金法检测HBsAg漏检原因分析及预防措施

Undetected reasons analysis and prevention measures of colloidal gold method in the detection of HBsAg

目的:探讨胶体金法检测无偿献血者乙型肝炎病毒表面抗原(HBs Ag)漏检的原因及预防措施。方法:将胶体金法检测结果为阴性的样本应用酶联免疫吸附试验(ELISA法)检测,对检测结果为阳性的样本再次应用胶体金法进行检测,并对胶体金法漏检的原因进行分析。结果:46 000例无偿献血者ELISA法共检出226例HBs Ag阳性,阳性率0.49%,226例ELISA法阳性样本再次应用胶体金法检测,58例阳性。结论:方法学限制及人为因素是胶体金法筛查HBs Ag漏检的主要原因,严格试剂使用前筛选、考评,提高医务人员检测技能、质量意识及加强责任心可降低胶体金法漏检。

Objective:To explore the undetected reasons and prevention measures of colloidal gold method in the detection of hepatitis B surface antigens(HBsAg) in volunteer donors.Methods:The sample with negative colloidal gold method test result was applied enzyme linked immunosorbent assay(ELISA method) for detection.The sample with positive test result was applied again colloidal gold method for detection.The undetected reasons of colloidal gold method were analyzed.Results:In 46 000 cases of volunteer donors,ELISA method detected 226 cases of HBsAg positive,and the positive rate was 0.49%.226 cases of ELISA method positive samples were applied again colloidal gold method for detection,and 58 cases were positive.Conclusion:Methodological limitations and man-made factors are the undetected main reasons of screening HBsAg by colloidal gold method.Strict reagent screening and evaluation before use,improving medical personnel testing skills and quality awareness,strengthening responsibility can reduce the leak detection of colloidal gold method.