Recalibration of Blood Analytes over 25 Years in the Atherosclerosis Risk in Communities Study: Impact of Recalibration on Chronic Kidney Disease Prevalence and Incidence
Recalibration of Blood Analytes over 25 Years in the Atherosclerosis Risk in Communities Study: Impact of Recalibration on Chronic Kidney Disease Prevalence and Incidence
复制标题
DOI：
10.1373/clinchem.2015.238873
复制
发表时间：
2015-07-01
影响因子：
9.3
通讯作者：
Coresh, Josef
中科院分区：
文献类型：
--
作者：
Parrinello, Christina M.;Grams, Morgan E.;Coresh, Josef
背景：随着时间的推移，实验室测试的等效性对于纵向研究很重要。即使很小的系统差异（偏差）也可能导致严重的错误分类。方法：我们选择了 200 名社区动脉粥样硬化风险研究参与者，参加了 25 年来的所有 5 次研究访问。 2011-2013 年，从多次就诊的储存血样中重新测量了八种分析物：肌酐、尿酸、葡萄糖、总胆固醇、HDL 胆固醇、LDL 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测量的值。差异 >10% 被认为反映了重大偏差，并且对整个研究群体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。结果：重复测量值与原始值高度相关 [去除异常值后 Pearson r > 0.85（配对测量值的中位数 4.5%）]，但 8 种分析物（肌酐和尿酸）中有 2 种差异 >10%。使用校正方程将肌酐和尿酸的原始值重新校准为当前值。肌酐重新校准后，CKD 患病率存在显着差异（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：1.3%、2.2%、6.4% 和 29.4%）。对于 HDL 胆固醇，当前的直接酶法与第 1-4 次访视期间使用的葡聚糖镁沉淀法有很大不同。 结论：在储存约 25 年的样品中重新测量的分析物与原始值高度相关，但 8 种分析物中的 2 种在多次访视时显示出显着偏差。实验室重新校准提高了每次就诊时测试结果的可重复性，并导致 CKD 患病率存在显着差异。我们证明了在队列研究中一致重新校准实验室测定的重要性。 (C) 2015年美国临床化学协会
BACKGROUND: Equivalence of laboratory tests over time is important for longitudinal studies. Even a small systematic difference (bias) can result in substantial misclassification.METHODS: 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.RESULTS: 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.CONCLUSIONS: 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. (C) 2015 American Association for Clinical Chemistry