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目的评价慢性粒细胞白血病(chronic myeloid leukemia,CML)ssDNA适配子检测方法的临床诊断应用价值。方法基于前期构建的方法,用ssDNA适配子与K562细胞及临床CML标本结合进行检测,在优化的检测条件下,以美国临床实验室标准化组织(Clinical and Laboratory Standard Institude,CLSL)的相关标准为依据,对该方法进行方法学评价,并对方法进行临床诊断性能的评价。结果建立的方法回归方程为:y=1 476.4+495.31 x,r2=0.976 6,拟合度较高;该方法敏感性较高,特异性较强,检测高、中、低浓度的K562细胞的批内变异系数均小于5%,日间变异系数均大于5%;该方法测得的不同浓度CML标本的总平均回收率为78.7%;测得的溶血、黄疸及血脂标本的平均干扰率均>10.0%;ROC曲线下面积为0.867,ssDNA适配子检测CML组、非慢粒类型白血病组、健康对照组标本的敏感度为75%,特异度为77%,阳性似然比为3.26,阴性似然比为0.32,漏诊率为25%,可靠度为0.306,可用度为0.52。结论 CML ssDNA适配子检测方法本身灵敏度高,检测阈值低,特异性强;在临床诊断性能研究中,该方法特异性高,但敏感性较低,具有一定的临床诊断价值。但该方法抗干扰能力弱,重复性较差,且可靠度<0.5,其临床应用还有一定的局限性。
Objective To evaluate the clinical diagnostic value of ssDNA aptamer detection in chronic myeloid leukemia (CML). Methods Based on the previous method, ssDNA aptamers were tested in combination with K562 cells and clinical specimens of CML. Under the optimized detection conditions, the standard of CLSL (Clinical and Laboratory Standard Institude) was Based on this method of methodological evaluation, and methods of clinical diagnostic performance evaluation. Results The regression equation of the established method was: y = 1 476.4 + 495.31 x, r2 = 0.976 6, the fitting degree was higher; the method was more sensitive and specific, and the detection of high, medium and low concentrations of K562 cells The intra-assay CVs were all less than 5% and the intra-day CVs were all more than 5%. The overall average recovery of CML samples with different concentrations was 78.7%. The mean interference rates of hemolysis, jaundice and blood lipids were > 10.0%. The area under the ROC curve was 0.867. The sensitivity of ssDNA aptamers in CML group and non-CML group was 75%, specificity was 77%, positive likelihood ratio was 3.26, Negative likelihood ratio was 0.32, missed diagnosis rate was 25%, reliability was 0.306, availability was 0.52. Conclusion The detection method of CML ssDNA aptamer has high sensitivity, low detection threshold and high specificity. The method is highly specific and has low sensitivity in clinical diagnosis, and has certain clinical diagnostic value. However, this method has weak anti-interference ability and poor repeatability, and its reliability is less than 0.5. Its clinical application still has some limitations.