CAJ | 학술논문

目的：对临床化学项目处于不同医学决定水平和生物学参考区间上下限的不确定度进行评估，并且探讨其临床应用价值。方法采用“自上而下”的方法评定测量不确定度，统计2012~2013年卫生部室间质评结果和室内质量控制数据，确定偏移u（ bias）、实验室内测量复现性u（ Rw）和校准u（ cal）为不确定度评估的三个分量，合成相对标准不确定度，进而得出相对扩展不确定度和扩展不确定度U。结果分别得出临床生化项目（14个）在不同医学决定水平和生物学参考区间上下限的测量不确定度，包括3个离子类（ K、Na、Cl）、4个肝功能类（ TP、Alb、ALT、AKP）、4个肾功能类（ BUN、Crea、UA、Glu）、2个血脂类（ TG、CHO）和1个心肌酶类（ CK）。结论对临床化学项目的测量不确定度进行评估，有着重要的临床应用价值。它为临床说明了检测结果的可置信区间，有助于临床改进对患者结果的解释与应用，特别是处于医学决定水平和生物参考区间上下限的结果，有助于临床诊疗。
목적：대림상화학항목처우불동의학결정수평화생물학삼고구간상하한적불학정도진행평고，병차탐토기림상응용개치。방법채용“자상이하”적방법평정측량불학정도，통계2012~2013년위생부실간질평결과화실내질량공제수거，학정편이u（ bias）、실험실내측량복현성u（ Rw）화교준u（ cal）위불학정도평고적삼개분량，합성상대표준불학정도，진이득출상대확전불학정도화확전불학정도U。결과분별득출림상생화항목（14개）재불동의학결정수평화생물학삼고구간상하한적측량불학정도，포괄3개리자류（ K、Na、Cl）、4개간공능류（ TP、Alb、ALT、AKP）、4개신공능류（ BUN、Crea、UA、Glu）、2개혈지류（ TG、CHO）화1개심기매류（ CK）。결론대림상화학항목적측량불학정도진행평고，유착중요적림상응용개치。타위림상설명료검측결과적가치신구간，유조우림상개진대환자결과적해석여응용，특별시처우의학결정수평화생물삼고구간상하한적결과，유조우림상진료。
Objective To evaluate the uncertainty of the clinical chemical items in different medical decision level and upper and lower limits of biological reference interval ,and to explore its clinical application value. Methods Using a "top-down" approach to estimate the measurement uncertainty,to count the internal quality control data from 1~6 month of 2013 and the external quality assessment data from 2012~2013,to determine the deviation of U(bias),the laboratory measurement reproducibility of U(Rw)and the calibration of U(cal)as the three components of the uncertainty evaluation,and to combine the relative standard uncertainty ucrel,then to get the relative expanded uncertainty Urel and expanded uncertainty U. Results There were 14 measurement uncertainty of cinical biochemistry projects in different levels of medical deci-sions and biological reference intervals ,including three ion species( K,Na,Cl),4 hepatic functional class( TP,Alb ,ALT,AKP),4 kidneys functional class( BUN,Crea,UA,Glu),2 changes of lipid classes( TG,CHO)and 1 cardiac enzyme class( CK). Conclusion Evaluation of the measurement uncertainty of clinical chemical items has important clinical value. It shows the confidence interval for the clinical detection re-sults,contributing to the clinical improvement to the interpretation and application of the patient results,especially the results in medical decision level and upper and lower limits of biological reference interval,and to guide the clinical diagnosis and disease monitoring.