Parrinello Christina M, Grams Morgan E, Couper David, Ballantyne Christie M, Hoogeveen Ron C, Eckfeldt John H, Selvin Elizabeth, Coresh Josef
Department of Epidemiology and the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD;
Department of Epidemiology and the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; Division of Nephrology and.
Clin Chem. 2015 Jul;61(7):938-47. doi: 10.1373/clinchem.2015.238873. Epub 2015 May 7.
Equivalence of laboratory tests over time is important for longitudinal studies. Even a small systematic difference (bias) can result in substantial misclassification.
We selected 200 Atherosclerosis Risk in Communities Study participants attending all 5 study visits over 25 years. Eight analytes were remeasured in 2011-2013 from stored blood samples from multiple visits: creatinine, uric acid, glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and high-sensitivity C-reactive protein. Original values were recalibrated to remeasured values with Deming regression. Differences >10% were considered to reflect substantial bias, and correction equations were applied to affected analytes in the total study population. We examined trends in chronic kidney disease (CKD) pre- and postrecalibration.
Repeat measures were highly correlated with original values [Pearson r > 0.85 after removing outliers (median 4.5% of paired measurements)], but 2 of 8 analytes (creatinine and uric acid) had differences >10%. Original values of creatinine and uric acid were recalibrated to current values with correction equations. CKD prevalence differed substantially after recalibration of creatinine (visits 1, 2, 4, and 5 prerecalibration: 21.7%, 36.1%, 3.5%, and 29.4%, respectively; postrecalibration: 1.3%, 2.2%, 6.4%, and 29.4%). For HDL cholesterol, the current direct enzymatic method differed substantially from magnesium dextran precipitation used during visits 1-4.
Analytes remeasured in samples stored for approximately 25 years were highly correlated with original values, but 2 of the 8 analytes showed substantial bias at multiple visits. Laboratory recalibration improved reproducibility of test results across visits and resulted in substantial differences in CKD prevalence. We demonstrate the importance of consistent recalibration of laboratory assays in a cohort study.
实验室检测结果随时间的等效性对于纵向研究很重要。即使是很小的系统差异(偏差)也可能导致大量的错误分类。
我们从参加了超过25年的全部5次社区动脉粥样硬化风险研究访视的参与者中选取了200名。在2011 - 2013年,对多次访视采集的储存血样中的8种分析物进行了重新检测:肌酐、尿酸、葡萄糖、总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯和高敏C反应蛋白。使用戴明回归将原始值重新校准为重新检测的值。差异>10%被认为反映了显著偏差,并对整个研究人群中受影响的分析物应用了校正方程。我们检查了重新校准前后慢性肾脏病(CKD)的趋势。
重复测量值与原始值高度相关[去除异常值后皮尔逊r>0.85(配对测量值中位数的4.5%)],但8种分析物中有2种(肌酐和尿酸)差异>10%。肌酐和尿酸的原始值通过校正方程重新校准为当前值。肌酐重新校准后,CKD患病率有显著差异(重新校准前第1、2、4和5次访视分别为21.7%、36.1%、3.5%和29.4%;重新校准后分别为1.3%、2.2%、6.4%和29.4%)。对于高密度脂蛋白胆固醇,当前的直接酶法与第1 - 4次访视期间使用的硫酸镁葡聚糖沉淀法有显著差异。
在储存约25年的样本中重新检测的分析物与原始值高度相关,但8种分析物中有2种在多次访视中显示出显著偏差。实验室重新校准提高了各次访视间检测结果的可重复性,并导致CKD患病率有显著差异。我们在一项队列研究中证明了实验室检测持续重新校准的重要性。