CAJ | 학술논문

目的：探讨血清载脂蛋白AⅠ（ ApoAⅠ）吸光度－浓度校准曲线的最适拟合模型，以建立并优化定量检测系统，并通过对不同检测系统进行方法比对分析，探讨各系统检测载脂蛋白ApoAⅠ和B100结果是否具有可比性。方法ApoAⅠ校准物吸光度检测采用免疫透射比浊法，对ApoAⅠ校准物吸光度与浓度进行线性模型、二次多项式模型、三次多项式模型、s模型、Logistic模型等模型的曲线拟合，并根据各回归模型决定系数（ r2）的大小来确定最适拟合模型。用经过自身校准后的3个检测系统分别检测不同浓度的血清和质控物指标：ApoAⅠ和ApoB100，然后用最可靠的A系统校准另外2个系统后再重复测定血清和质控物，比较经过A系统校准前后另外2个系统测定的相对偏差大小，并按照1988年美国临床实验室修正案（CLIA′88）标准进行临床可接受性能判断。结果 ApoAⅠ校准物吸光度与浓度的散点图呈非线性趋势；线性模型、二次多项式模型、三次多项式模型、s模型Logistic模型的回归方程均有意义（ P＜0．05），其中二次多项式模型、三次多项式模型、s模型的拟合效果较好，以三次多项式模型为最佳。所测的ApoAⅠ和B100与标准系统的相关性好，结果可接受。结论三次多项式模型是载脂蛋白吸光度与浓度校准曲线的最适拟合模型。当实验室内存在2套和2套以上检测系统时，应对其进行方法比对和偏倚评估，才能保证检测结果的准确性和一致性。
목적：탐토혈청재지단백AⅠ（ ApoAⅠ）흡광도－농도교준곡선적최괄의합모형，이건립병우화정량검측계통，병통과대불동검측계통진행방법비대분석，탐토각계통검측재지단백ApoAⅠ화B100결과시부구유가비성。방법ApoAⅠ교준물흡광도검측채용면역투사비탁법，대ApoAⅠ교준물흡광도여농도진행선성모형、이차다항식모형、삼차다항식모형、s모형、Logistic모형등모형적곡선의합，병근거각회귀모형결정계수（ r2）적대소래학정최괄의합모형。용경과자신교준후적3개검측계통분별검측불동농도적혈청화질공물지표：ApoAⅠ화ApoB100，연후용최가고적A계통교준령외2개계통후재중복측정혈청화질공물，비교경과A계통교준전후령외2개계통측정적상대편차대소，병안조1988년미국림상실험실수정안（CLIA′88）표준진행림상가접수성능판단。결과 ApoAⅠ교준물흡광도여농도적산점도정비선성추세；선성모형、이차다항식모형、삼차다항식모형、s모형Logistic모형적회귀방정균유의의（ P＜0．05），기중이차다항식모형、삼차다항식모형、s모형적의합효과교호，이삼차다항식모형위최가。소측적ApoAⅠ화B100여표준계통적상관성호，결과가접수。결론삼차다항식모형시재지단백흡광도여농도교준곡선적최괄의합모형。당실험실내존재2투화2투이상검측계통시，응대기진행방법비대화편의평고，재능보증검측결과적준학성화일치성。
Abstracts:Objective To study the serum apolipoprotein AⅠ( ApoAⅠ) best fit model of 5 kinds of the absorbance-concentration cal-ibration curve models and to establish and optimize the quantitative detection system.To discuss the comparison of apolipoprotein ApoAⅠand ApoB100 results among different detection systems.Methods ApoAⅠ calibrator absorbance were detected by immune nephelometry.The ApoAⅠabsorbance-concentration calibration curve models were analyzed including linear model, quadratic model, cubic polynomial mod-el, s model and Logistic model to observe the curve fitting the regression model based on the coefficient of determination ( r2 ) , to determine the optimal size of the fitting model.Three detection systems after corresponding calibration were used to detect different concentrations of ser-um and quality control material including detecting items such as ApoAⅠand ApoB100.The most reliable A system was used to calibrate the two other systems.The serum and quality control material were measured again with the two other systems.The differences of bias between two other detection systems were compared before and after calibration.That was judged by the clinical acception according to clinical laboratory improvement amendment(CLIA′88).Results ApoAⅠabsorbance-concentration calibration curve was non-linear trend.Linear model, quadratic model, cubic polynomial model, s model and Logistic regression models were significant (P<0.05).Which quadratic model, the cubic polynomial model and s model fitting accuracy was better, the best was cubic polynomial model.The measured apolipoprotein AⅠand B100 associated with the standard system was good and the results were acceptable.Conclusion Cubic polynomial model is the best fitting model of the apolipoprotein absorbance -concentration calibration curve.If there are two or more detective systems in lab, the method com-parison and bias evaluation should be performed to ensure the accuracy and the consistency of the report.