全血分析仪室内质量控制规则的选择与评价

Selection and evaluation of internal quality control rule for hematology analyzers

目的为COULTERSTK全自动细胞分析仪选择满足临床质量要求的质控规则。方法以CLIA88能力比对验证为"允许总误差"对每项测定规定质量要求,确定各测定方法稳定操作下的不精密度或标准差、不准确度或偏倚,绘制操作过程规范图,画出操作点,通过评价候选质控方法的误差检出概率(Ped)和假失控概率(Pfr),选择质控规则。结果血红蛋白、白细胞、MCV、MCH使用13.5s质控规则(n=1);红细胞、MCHC使用13s质控规则(n=1);红细胞压积使用12.5s质控规则(n=1);血小板使用Westgard多规则(13s/22s/R4s/41s/10x)(n=2)均可达到90%的Ped。白细胞低值标本不准确度较大(偏倚4.5%),采用13s/22s/R4s/41s/8x多规则进行判断,n=2时Pfr为0.038,Ped为50%。结论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测定的个数,使误差检出概率和假失控概率达到临床工作的要求。

Objective To design the quality control procedure needed to satisfy clinical quality requirement for COULTER STK automatic hematology analyzer. Methods The analytical quality requirement was defined for the test with an allowable total error （TEa） needed to satisfy the given CLIA＇88 proficiency testing （PT） criteria. The imprecision or standard deviation from internal quality control and inaccuracy or biases from external quality control were determined under stable performance. The Operational Process Specifications Chart （OPSpecs chart） was drawed, and the operating points were marked. The quality control rule was selected by assessing the probabilities of error detec- tion and false rejection for candidate control procedure. Results 13.s~ （n= 1）, 13~ （n= 1）, 12. s~ quality control rule （n=l） and Westgard multi-rule （13s/22s/R4s/41s/10） （n=2） was applied in the measure- ment of hemoglobin, WBC, MCV and MCH respectively. The probability of error detection accounted for 90%. The inaccuracy of WBC low valued samples was relatively higher （bias value was 4. 5%）. The probability of error detection and false rejection was 50% and 0. 038 respectively when Westgard multi-rule （132/22s/R42/41s/lO）（n=2） was applied in the measurement of platelet. Conclusion OP- Specs chart can provide an easy way to select quality control rule and number of quality control samples so as to ensure the probabilities of error detection and false rejection achieving the demand of the clinic.