凝血试验室内质控方法的评价与选

目的对凝血分析仪的现用质控规则进行评价。方法以CLIA’88能力比对评价限设定为允许总误差（TEa）,以卫生部临床检验中心室间质评结果计算Bias,以连续1年的凝血仪室内质控测定CV值为方法的不精密度,利用方法决定图评价现用凝血项目PT、APTT和Fg的质控规则。绘制操作过程规范图,通过误差检出概率（Ped）和假失控概率（Pfr）选择满足临床要求的质控方法。结果现行室内质控方法的APTT和Fg属于＂良好＂性能,PT属于＂临界＂性能。质控规则的选择为：APTT使用13s/22s/R4s/41s/10X质控规则（n=2,Ped=90%,Pfr=1.4%）;Fg使用13s/22s/R4s/41s/10X质控规则（n=2,Ped=90%,Pfr=1.4%）;PT不准确度较大（5.04%）,只有增加质控物个数使n=3和降低Ped为25%才可以选到规则,但不能满足临床要求。结论方法决定图能简便地评价现用质控规则的性能,通过操作过程规范图能够简便地选择满足临床检验所需要的质控规则和质控品个数,使误差检出概率和假失控概率达到临床工作的要求。

Evaluation and Selection of Internal Quality Control Procedures in Coagulation Tests

Objective To evaluate the current quality control procedures in coagulation tests for coagulation analyzer.Methods The allowable total error（TEa） was defined by proficiency testing criteria,the bias was calculated from results of external quality control,and imprecision was derived from results of internal quality control among last year.Current control rules of PT,APTT and Fg were assessed by method evaluation decision chart.The control rules and numbers that can fit for clinical requests were selected by operational process specifications（OPSpecs） charts.Results The performance of current control rules：APTT and Fg wer＂egood＂,and PT was＂ borderline＂.When the probability of error detection（Ped） was 90%（or greater）,the selected rules of APTT were 13s/22s/R4s/41s/10X（n=2）,and Fg,13s/22s/R4s/41s/10X（n=2）.Because of a greater inaccuracy of PT（5.04%）,Ped was minimized to 25%,but it could not fit for the clinical quality requests.Conclusion OPSpecs chart was an easy way to select the control rules and numbers in the clinical laboratory.