CAJ | 학술논문

目的：对便携式全自动快速生化分析仪及配套干式微管生物芯片肝功能试剂盘进行性能评价。方法参照美国临床和实验室标准化协会（CLSI）颁布的EP10‐A2文件，连续5 d按特定顺序检测高、中、低值标本，计算测定结果的绝对偏倚、总不精密度，对检测结果回归曲线的截距、斜率及非线性、携带污染和漂移进行多元回归分析。结果各项目同浓度水平标本检测结果的绝对偏倚和总不精密度均在允许范围内，截距、斜率、非线性、携带污染、漂移均无统计学意义（P＞0．05）。结论便携式生化分析仪及配套肝功能试剂盘准确度、精密度、线性良好，携带污染率较低，稳定性好，能满足临床应用要求。
목적：대편휴식전자동쾌속생화분석의급배투간식미관생물심편간공능시제반진행성능평개。방법삼조미국림상화실험실표준화협회（CLSI）반포적EP10‐A2문건，련속5 d안특정순서검측고、중、저치표본，계산측정결과적절대편의、총불정밀도，대검측결과회귀곡선적절거、사솔급비선성、휴대오염화표이진행다원회귀분석。결과각항목동농도수평표본검측결과적절대편의화총불정밀도균재윤허범위내，절거、사솔、비선성、휴대오염、표이균무통계학의의（P＞0．05）。결론편휴식생화분석의급배투간공능시제반준학도、정밀도、선성량호，휴대오염솔교저，은정성호，능만족림상응용요구。
Objective To evaluate the performance portable analyzer and reagent disc kit for liver function tests .Methods Ac‐cording to EP10‐A2 document of Clinic and Laboratory Standards Institute ,specimens with high ,medium and low concentrations were measured continuously in a specific order for 5 days .The bias and the total imprecision were calculated ,and the intercept ,slope rate ,non linearity ,carryover contamination and drift were analyzed by using multiple regression analysis .Results The bias and pre‐cision of specimens with high ,medium and low concentrations were all within acceptable ranges .No significant difference was showed in intercept ,slope rate ,non linearity ,carryover contamination and drift(P>0 .05) .Conclusion Portable analyzer and rea‐gent disc kit for liver function tests could be with fine precision ,fine linearity ,low carryover contamination and good stability ,and could meet clinical application requirement .