CAJ | 학술논문

目的：运用2种比对方案对不同生化检测系统的常规检验项目进行方法比对、偏倚评估和校准，探讨不同生化检测系统间项目测定结果的可比性及量值溯源，为实现不同实验室间检验结果一致性提供实践经验。方法参照 WS／T407‐2012文件，通过对各检测系统参加该研究的9个项目室内质控数据进行初步性能评价，以项目最大变异系数（CV）与最小 CV 间差异小于2倍者参照 WS／T407‐2012文件方案进行比对；以项目最大 CV 与最小 CV 间差异大于2倍者参照美国临床和实验室标准化协会（CLSI） EP9‐A2文件方案进行比对；用目标检测系统赋值的新鲜血清对不具可比性的项目作校准，再进行偏倚评估，实现量值溯源。结果初步性能评价显示除了丙氨酸氨基转移酶（ALT ），其余项目最大 CV 与最小 CV 间的差异小于2倍；参照 WS／T407‐2012比对方案，检测系统1的总胆固醇、总蛋白，检测系统2的尿素氮，检测系统3的总蛋白偏差（R 值）大于1／3允许误差，结果不具可比性；用赋值的新鲜血清校准后再进行可比性验证，各项目的偏差 R 值小于1／3允许误差，符合比对要求；参照 EP9‐A2比对方案，将各检测系统与目标系统的 ALT 进行相关分析，检测系统2在医学决定水平（20 U ／L）的相对偏差（SE％）大于1／2美国临床实验室改进规范（CLIA′88），结果不具可比性；各试验系统经赋值的新鲜血清校准后再与目标系统进行相关分析和可比性验证，检测系统2的 SE％小于1／2 CLIA′88，符合比对要求；检测系统1的 SE％较赋值校准前有明显改善。结论不同生化检测系统的检验项目通过方法比对和偏倚评估，并应用新鲜血清赋值校准和校准后可比性验证的方式实现量值溯源，是达成区域内各级医院检验结果互认的可行途径。
목적：운용2충비대방안대불동생화검측계통적상규검험항목진행방법비대、편의평고화교준，탐토불동생화검측계통간항목측정결과적가비성급량치소원，위실현불동실험실간검험결과일치성제공실천경험。방법삼조 WS／T407‐2012문건，통과대각검측계통삼가해연구적9개항목실내질공수거진행초보성능평개，이항목최대변이계수（CV）여최소 CV 간차이소우2배자삼조 WS／T407‐2012문건방안진행비대；이항목최대 CV 여최소 CV 간차이대우2배자삼조미국림상화실험실표준화협회（CLSI） EP9‐A2문건방안진행비대；용목표검측계통부치적신선혈청대불구가비성적항목작교준，재진행편의평고，실현량치소원。결과초보성능평개현시제료병안산안기전이매（ALT ），기여항목최대 CV 여최소 CV 간적차이소우2배；삼조 WS／T407‐2012비대방안，검측계통1적총담고순、총단백，검측계통2적뇨소담，검측계통3적총단백편차（R 치）대우1／3윤허오차，결과불구가비성；용부치적신선혈청교준후재진행가비성험증，각항목적편차 R 치소우1／3윤허오차，부합비대요구；삼조 EP9‐A2비대방안，장각검측계통여목표계통적 ALT 진행상관분석，검측계통2재의학결정수평（20 U ／L）적상대편차（SE％）대우1／2미국림상실험실개진규범（CLIA′88），결과불구가비성；각시험계통경부치적신선혈청교준후재여목표계통진행상관분석화가비성험증，검측계통2적 SE％소우1／2 CLIA′88，부합비대요구；검측계통1적 SE％교부치교준전유명현개선。결론불동생화검측계통적검험항목통과방법비대화편의평고，병응용신선혈청부치교준화교준후가비성험증적방식실현량치소원，시체성구역내각급의원검험결과호인적가행도경。
Objective To investigate the comparability and metrological traceability of results from different laboratories and providing practical experience for results uniformity on routine biochemical items ,to conduct two comparison schemes to perform contrast and bias estimation and calibration on the results of routine biochemical items among different biochemical measurement systems .Methods According to protocol WS/T407‐2012 ,preliminary evaluation was achieved base on indoor quality control data of the 9 items among the measurement system .The comparison scheme of WS/T407‐2012 was conducted for the results with differ‐ence between maximum coefficient of variation(CV ,CVmax)and CVmin less than two times ,and the scheme of Clinic and Laborato‐ry Standards Institute(CLSI) EP9‐A2 for the results with difference between CVmax and CVmin greater than two times .The fresh serum samples were used and assigned by the aim measurement system as the calibrator to calibrate the items that incomparable ,e‐valuating the bias and achieving traceability .Results All the items except alanine aminotransferase(ALT ) had differences between CVmax and CVmin less than two times .The bias(R value)of total cholesterol ,total protein in measurement system 1 ,urea nitrogen in measurement system 2 ,and total protein in measurement system 3 had more than 1/3 permissible error ,which were incomparable according to WS/T407‐2012 requirements .After calibrated by assigned flesh serum and redone the estimation ,all the R value of these items achieved less than 1/3 permissible error level and meet the requirements .The correlation analysis was conducted for ALT according to CLSI EP9‐A2 .The relative deviation (SE% ) of ALT in measurement system 2 has more than the half of clinical laboratory improvement amendment 88 (CLIA′88) on medicine decide level(20 U /L) ,which is not comparable .Correlation analysis and comparable validation was rebuilt in aim measurement system and calibrated by flesh serum assigned .The SE% of measure‐ment system 2 shows less than the half of CLIA′88 ,which could fit in the allowed total error requirements .The result measurement system 1 also showed improvement after calibrated .Conclusion After the items calibrated by assigned fresh serum samples ,meas‐urement comparison and bias estimation could be applied in routine biochemical tests among different laboratories for data traceabili‐ty and comparable .It could be a feasible approach to achieve laboratory result mutual accredit in different hospitals .