CAJ | 학술논문

目的为COULTER STK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/10xn=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.
목적 위COULTER STK전자동세포분석의선택만족림상질량요구적질공규칙.방법 이CLIA88능력비대험증위"윤허총오차"대매항측정규정질량요구,학정각측정방법은정조작하적불정밀도혹표준차、불준학도혹편의,회제조작과정규범도,화출조작점,통과평개후선질공방법적오차검출개솔(Ped)화가실공개솔(Pfr),선택질공규칙.결과 혈홍단백、백세포、MCV、MCH사용13.5s질공규칙(n=1);홍세포、MCHC사용13s질공규칙(n=1);홍세포압적사용12.5s질공규칙(n=1);혈소판사용Westgard다규칙(13s/22s/R4s/41s/10xn=2)균가체도90%적Ped.백세포저치표본불준학도교대(편의4.5%),채용13s/22s/R4s/41s/8x다규칙진행판단,n=2시Pfr위0.038,Ped위50%.결론 통과조작과정규범도능구간편지선택만족림상검험소수요적질공규칙화질공품측정적개수,사오차검출개솔화가실공개솔체도림상공작적요구.
Objective To design the quality control procedure needed to satisfy clinical quality requirement for COULTER STK automatic hematology analyzer. Methods The analytical quality re- quirement was defined for the test with an allowable total error (Tea) needed to satisfy the given CLIA88 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 perform- ance. 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 13.5s, (n=1), 13s(n = 1 ), 12.5s quality control rule (n= 1) and Westgard multi-rule (13s/2,2s/R,4s/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 (13s/23s/R,4s/10)(n=2) was applied in the measurement of platelet. Conclusion UP- 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 clin- ic.