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目的评价HBsAg ELISA诊断试剂盒的质量。方法应用ELISA法对HBsAg国家标准品血清盘、临床科研血清盘、临界值质控血清等进行检测,考评HBsAg诊断试剂盒质量。结果6个厂家试剂均符合国家标准品血清盘判读标准,均能检测出1IU/ml定值质控血清,但测出S/CO值却差异较大,用临床科研血清盘检测,其试剂的灵敏度、特异性、总符合率存在差异。结论不同厂家试剂质量仍存在差异,使用前应进行抽检,综合评价,选择具有灵敏度高、特异性强、精密度好的试剂,优选两种匹配较好的试剂,从而提高HBsAg检出率,减少HBsAg漏检率,有利于控制和减少乙型肝炎的输血传播。
Objective To evaluate the quality of HBsAg ELISA diagnostic kit. Methods Serum plate of HBsAg national standard, serum plate of clinical research, quality control serum of serum were tested by ELISA, and the quality of HBsAg diagnostic kit was evaluated. Results The reagents of 6 manufacturers all met the standards of national standards for serum disk readout, which could detect 1IU / ml quality control sera, but the S / CO values were significantly different. Serum samples of clinical reagents Sensitivity, specificity, total coincidence rate differences. Conclusion Reagents of different manufacturers are still different in quality, sampling and comprehensive evaluation should be conducted before use, and reagents with high sensitivity, specificity and precision are selected, and two reagents with better matching are selected so as to improve the detection rate of HBsAg and reduce HBsAg undetectable rate, is conducive to control and reduce hepatitis B transfusion.