质量控制数据在室内质控品稳定性期间核查中的应用

目的利用前后两组质量控制数据进行统计学分析,对室内质控品进行期间核查,以确保质控品的稳定性,建立一种适合医学实验室室内质控品期间核查的新方法。方法利用乙型肝炎表面抗原,丙型肝炎抗体,梅毒抗体,HIV抗体室内质控品,使用期内前后各2个时间段的质量控制数据,统计分析前后2组数据差异有无统计学意义,判断室内质控品在2组数据之间时间段内的稳定状态。结果统计分析2组数据,丙型肝炎抗体,梅毒抗体,HIV抗体2个时间段的数据差异无统计学意义(P0.05),说明质控品在使用过程中保持了稳定性。乙型肝炎表面抗原的2组数据差异有统计学意义(P0.05),说明质控品在这段时间内没有保持良好的稳定性,应该采取措施。结论利用从室内质控中获得的质量控制数据计算出的均值(x)和标准差(s),进行统计学分析,判断2个时间段的数据差异有无统计学意义,从而达到对室内质控品期间核查的目的。

Application of quality control data in verification of stability of indoor control

Objective To establish a new method for the verification of the interior quality control products of Medical Laborato ry by using the quality control data of the two groups to check the quality of the interior quality control products during the verification.Methods Take use of quality control data of HBsAg,HCV-Ab,Syphilis antibody and HIV antibody of two time periods before and after during the period of validity to analyze difference in the two groups before and after data and judge the stability of interior quality control products between the before and after.Results There was no significant difference between the two groups in the data of before and after(P＞0.05),indicating that the control products maintained stability during the process.The difference of the two groups of HBsAg was statistically significant(P＜0.05),indicating that the control product did not maintain good stability during this period,and measures should be taken.Conclusion Make statistical analysis of the mean((x)) and standard deviation(s) calculated from the quality control data obtained from the laboratory quality control,analyzing data whether the differences between the two time periods was statistically significant,so as to achieve internal quality control during product verification purposes