CAJ | 학술논문

目的：讨论临床实验室定量测定室内统计质量控制程序中质控图控制界限的设定问题。方法使用SPSS14．0统计软件对血清清蛋白（ALB）、丙氨酸氨基转移酶（ALT）、肌酐（Cr）3个项目每月质控数据作正态性检验并与累积数作比较。结果30组数据中有18个正态性检验不符合，30组均数 t 检验有20组差异具有统计学意义（P ＜0．05），因此短期内计算出的均数和标准差不能直接应用为质控图的控制限。结论临床实验室定量检测室内质量控制图控制限的设定应当按照 CLSI 的 C24-A3文件指导，使用稳定时期大量质控数据得到的标准差估计值或6个月累积值作为新批号的标准差，并定期评估。
목적：토론림상실험실정량측정실내통계질량공제정서중질공도공제계한적설정문제。방법사용SPSS14．0통계연건대혈청청단백（ALB）、병안산안기전이매（ALT）、기항（Cr）3개항목매월질공수거작정태성검험병여루적수작비교。결과30조수거중유18개정태성검험불부합，30조균수 t 검험유20조차이구유통계학의의（P ＜0．05），인차단기내계산출적균수화표준차불능직접응용위질공도적공제한。결론림상실험실정량검측실내질량공제도공제한적설정응당안조 CLSI 적 C24-A3문건지도，사용은정시기대량질공수거득도적표준차고계치혹6개월루적치작위신비호적표준차，병정기평고。
Objective To discuss the setting problem of control limit for quality control chart during the statistical quality con-trol procedure of clinical laboratory quantitative measurement.Methods The normality test of the monthly quality control data for 3 items of albumin (ALB),alanine aminotransferase (ALT)and creatinine (Cr)was performed by using the SPSS 14.0 statistical software and which was compared with the cumulated data.Results Among 30 groups of data,the normality test was inconformity in 18 groups,among 30 groups of mean t test,the differences in 20 groups showed statistical significance(P <0.05).Therefore,the calculated means and standard deviation(SD)in short term could not be directly set as the control limit of the quality control chart. Conclusion Setting the control limit of internal quality control in clinical laboratory quantitative measurement should be according to the guidance of C24-A3 document in CLSI.The SD estimated value obtained from large amount stable quality control data or the 6-month cumulative values is recommended to be used as SD of the new batch number,which should be regularly assessed.