CAJ | 학술논문

目的调查国内临床实验室使用的6个系列进口配套γ谷氨酰转移酶(GGT)检测系统测定结果的精密度和正确度,为实验室酶学测定确定具有准确性的目标系统提供依据.方法国内两家候选酶学参考实验室使用国际临床化学和检验医学联合会(IFCC)推荐的GGT参考测量方法,为5个活性浓度水平的新鲜冰冻混合人血清确定靶值,实验人员用基于厂家配套校准品等方式校准的6个厂家配套检测系统对血清样本进行检测,每个厂家均由独立分布于5个实验室的5台仪器组成(其中1个厂家为2台),各台仪器于实验前由各厂家工程师进行了一次日常维护.收集检测数据,统计同一厂家检测系统、不同厂家检测系统间检测结果的精密度,及各厂家检测系统测定结果均值与参考方法靶值的偏倚.结果 6个厂家(A、B、C、D、E、F)配套测定系统间5个水平检测结果的差异为16.1%～35.4%;不同检测系统间5个水平样本测定结果的变异系数(CV)为5.3%～8.8%;同厂家配套检测系统间5个水平样本测定结果CV分别为A:2.17%～5.07%、B:4.21%～10.98%、C:0.52%～2.38%、D:1.35%～2.59%、E:0.23%～1.54%、F:1.83%～2.38%.各厂家测定系统检测结果均值与靶值的偏倚分别为A:0.43%～8.41%、B:-1.49%～-13.04%、C:11.2%-17.73%、D.0.19%～4.62%、E:-0.30%～-2.63%、F:-0.46%～7.90%.调查显示:有2个厂家结果在本次调查的浓度范围内偏倚均小于1/4美国<临床实验室改进法案修正案>(CLIA'88)规定的允许总误差(TAE);有2个厂家结果在特定浓度范围内偏倚可满足1/4 TAE;有2个厂家结果的偏倚在大多数情况下近于或大于1/2 TAE.调查同时显示:在高、低浓度水平,有半数以上调查厂家结果的偏倚大于1/4 TAE.结论不同厂家配套检测系统间结果的均值存在明显差异,其结果的可比性明显劣于同一厂家检测系统间的可比性;厂家应进一步保证其检测系统经参考方法校正,并应注重对检测系统测定线性的校正. 目的調查國內臨床實驗室使用的6箇繫列進口配套γ穀氨酰轉移酶(GGT)檢測繫統測定結果的精密度和正確度,為實驗室酶學測定確定具有準確性的目標繫統提供依據.方法國內兩傢候選酶學參攷實驗室使用國際臨床化學和檢驗醫學聯閤會(IFCC)推薦的GGT參攷測量方法,為5箇活性濃度水平的新鮮冰凍混閤人血清確定靶值,實驗人員用基于廠傢配套校準品等方式校準的6箇廠傢配套檢測繫統對血清樣本進行檢測,每箇廠傢均由獨立分佈于5箇實驗室的5檯儀器組成(其中1箇廠傢為2檯),各檯儀器于實驗前由各廠傢工程師進行瞭一次日常維護.收集檢測數據,統計同一廠傢檢測繫統、不同廠傢檢測繫統間檢測結果的精密度,及各廠傢檢測繫統測定結果均值與參攷方法靶值的偏倚.結果 6箇廠傢(A、B、C、D、E、F)配套測定繫統間5箇水平檢測結果的差異為16.1%～35.4%;不同檢測繫統間5箇水平樣本測定結果的變異繫數(CV)為5.3%～8.8%;同廠傢配套檢測繫統間5箇水平樣本測定結果CV分彆為A:2.17%～5.07%、B:4.21%～10.98%、C:0.52%～2.38%、D:1.35%～2.59%、E:0.23%～1.54%、F:1.83%～2.38%.各廠傢測定繫統檢測結果均值與靶值的偏倚分彆為A:0.43%～8.41%、B:-1.49%～-13.04%、C:11.2%-17.73%、D.0.19%～4.62%、E:-0.30%～-2.63%、F:-0.46%～7.90%.調查顯示:有2箇廠傢結果在本次調查的濃度範圍內偏倚均小于1/4美國<臨床實驗室改進法案脩正案>(CLIA'88)規定的允許總誤差(TAE);有2箇廠傢結果在特定濃度範圍內偏倚可滿足1/4 TAE;有2箇廠傢結果的偏倚在大多數情況下近于或大于1/2 TAE.調查同時顯示:在高、低濃度水平,有半數以上調查廠傢結果的偏倚大于1/4 TAE.結論不同廠傢配套檢測繫統間結果的均值存在明顯差異,其結果的可比性明顯劣于同一廠傢檢測繫統間的可比性;廠傢應進一步保證其檢測繫統經參攷方法校正,併應註重對檢測繫統測定線性的校正.
목적 조사국내림상실험실사용적6개계렬진구배투γ곡안선전이매(GGT)검측계통측정결과적정밀도화정학도,위실험실매학측정학정구유준학성적목표계통제공의거.방법 국내량가후선매학삼고실험실사용국제림상화학화검험의학연합회(IFCC)추천적GGT삼고측량방법,위5개활성농도수평적신선빙동혼합인혈청학정파치,실험인원용기우엄가배투교준품등방식교준적6개엄가배투검측계통대혈청양본진행검측,매개엄가균유독립분포우5개실험실적5태의기조성(기중1개엄가위2태),각태의기우실험전유각엄가공정사진행료일차일상유호.수집검측수거,통계동일엄가검측계통、불동엄가검측계통간검측결과적정밀도,급각엄가검측계통측정결과균치여삼고방법파치적편의.결과 6개엄가(A、B、C、D、E、F)배투측정계통간5개수평검측결과적차이위16.1%～35.4%;불동검측계통간5개수평양본측정결과적변이계수(CV)위5.3%～8.8%;동엄가배투검측계통간5개수평양본측정결과CV분별위A:2.17%～5.07%、B:4.21%～10.98%、C:0.52%～2.38%、D:1.35%～2.59%、E:0.23%～1.54%、F:1.83%～2.38%.각엄가측정계통검측결과균치여파치적편의분별위A:0.43%～8.41%、B:-1.49%～-13.04%、C:11.2%-17.73%、D.0.19%～4.62%、E:-0.30%～-2.63%、F:-0.46%～7.90%.조사현시:유2개엄가결과재본차조사적농도범위내편의균소우1/4미국<림상실험실개진법안수정안>(CLIA'88)규정적윤허총오차(TAE);유2개엄가결과재특정농도범위내편의가만족1/4 TAE;유2개엄가결과적편의재대다수정황하근우혹대우1/2 TAE.조사동시현시:재고、저농도수평,유반수이상조사엄가결과적편의대우1/4 TAE.결론 불동엄가배투검측계통간결과적균치존재명현차이,기결과적가비성명현렬우동일엄가검측계통간적가비성;엄가응진일보보증기검측계통경삼고방법교정,병응주중대검측계통측정선성적교정.
Objective To investigate the precision and trueness of results from six imported commercial systems for measurement of gamma-glutamyltransferase (GGT) in serum in order to provide reference for the clinical laboratories to verify the target accuracy. Methods Five fresh frozen human serum samples that differed in catalytic concentration were analyzed in two candidate domestic reference laboratories and the target values for GGT were assigned using IFCC reference measurement procedure. The same samples were tested by six commercial systems which were calibrated using the matched calibrator. Each system consisted of five instruments in five laboratories, which had been well maintained before measurement. The data was collected. Precision from the same manufacturer and different manufacturers and biases between target values and mean values from each system were calculated. Results The differences of the mean values for five levels of commercial systems varied from 16. 1% to 35.4%. For the five levels, the coefficients of variation (CVs) of the results from all measurement system were from 5.3% to 8. 8% , and CVs from each level were A 2. 17%- 5.07%, B 4. 21%-10. 98%, C 0. 52%-2. 38%, D 1.35%-2. 59%, E 0. 23%-1..54%-), F 1.83%-2. 38%. Biases between the mean values of each commercial systems and the target values were A 0. 43% -8.41% ), B -1.49% - -13.04% ), C 11.20% -17.73% ), D 0. 19% -4. 62% ), E -0. 30% - -2. 63% ), F 4). 46%-7.90%, respectively. The investigation showed that biases of two manufacturers were less than a quarter of the total allowable error (TAE) of The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) in the whole range of investigated concentrations and the other two manufacturers' biases could meet a quarter of TAE in a relative limited range. The biases of two manufacturers were near or more than half of TAE in most levels. It also revealed that the biases of more than half of manufacturers were more than a quarter of TAE in the low or high level of investigated concentrations. Conclusions The mean values of each manufacturer were significantly different. The variances of commercial systems from different manufacturers were much higher than those from the same manufacturer. Some imported commercial systems for measurement GGT should be better calibrated with the reference method, especially in the whole measurement linearity.