标准品血清在ELISA室内质量控制及结果判定中的运用探讨

The application of standard serum in ELISA indoor quality control and result determination

目的:探讨标准品血清在ELISA室内质量控制及结果判定中的运用效果。方法:以乙型肝炎表面抗原的测定为例,运用不同厂家、不同批次试剂盒同时对系列标准血清进行测定,从而通过这种方式得出定标后的质控品浓度。并且采用两厂家不同批次ELISA试剂盒对经微粒子酶免疫分析法定量的112份低浓度HBs Ag阳性血清进行检测,分别用cut-off界值法和血清浓度界值法判断结果,并且进行相应的评价。结果:通过血清浓度界值法进行质控,会使得所进行工作的结果变异小,不受不同厂家及批号更换的影响。因此血清浓度界值法结果稳定可靠,有利于避免在进行相应工作时质量的下降。结论:采用低浓度定标法的ELISA室内质控方法明显优于以吸光度/临界值为指标的ELISA室内质控方法,可更好的判断临界值附近样本的结果,有利于帮助研究人员减少漏检率,值得推广使用。

Objective To explore the effect of standard serum in quality control and outcome determination of ELISA.Methods The determination of hepatitis b surface antigen, for example, the use of different manufacturers, different batches kits series of standard serum were determined at the same time, thus in this way, it is concluded that the quality of product concentration after calibration. And using two different manufacturers batch ELISA kit for the micro particles quantitative 112 copies of low concentration enzyme immunoassay for detecting HBsAg positive serum, respectively with the cut-off boundary value method and the boundary value method to determine serum concentrations as a result, and the corresponding evaluation. Results The result of quality control by the serum concentration threshold method can make the results of the work have little variation, which is not affected by the change of different manufacturers and batch Numbers.Therefore, the results of serum concentration boundary value method are stable and reliable, which is beneficial to avoid the decrease of quality in the corresponding work Conclusion Low concentration calibration method of ELISA with absorbance/is obviously better than the indoor quality control method of the critical value as an index of ELISA method of indoor quality control, can better determine the result of the sample near the critical value, will help researchers to reduce the residual rate,worthy of promotion of use.