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比较基于家庭和实验室干血斑采样与常规实验室静脉血采样在 1 型或 2 型糖尿病成年患者中糖化血红蛋白结果的差异。

Comparison of Glycated Hemoglobin Results Based on At-Home and In-Lab Dried Blood Spot Sampling to Routine Venous Blood Sampling In-Lab in Adult Patients With Type 1 or Type 2 Diabetes.

机构信息

BC Diabetes, Vancouver, British Columbia, Canada; University of British Columbia, Vancouver, British Columbia, Canada.

University of British Columbia, Vancouver, British Columbia, Canada; Victoria Reference Laboratory, LifeLabs, Victoria, British Columbia, Canada.

出版信息

Can J Diabetes. 2018 Aug;42(4):426-432.e1. doi: 10.1016/j.jcjd.2017.10.053. Epub 2017 Dec 25.

Abstract

OBJECTIVES

Regular measurement of glycated hemoglobin (A1C) is logistically demanding. Home blotter-paper collection offers an alternative. This study tested the viability of at-home blotter-paper A1C measurement.

METHODS

Objective: compare accuracy of A1C levels collected on blotter paper at home (home-blotter) and blotter-paper collection in laboratory (lab-blotter) with venous A1C (routine measurement). Agreement was assessed by Pearson correlation, Lin concordance correlation coefficient (CCC), positive and negative predictive values (PPVs, NPVs) and Bland-Altman plots and associated statistics.

RESULTS

Home-blotter, lab-blotter and venous A1C correlated strongly (0.93, 0.93). Home- and lab-blotter results were upwardly biased (0.387%, 0.1%). Bias increased with time. Bias correction provided agreement for both blotters (CCC >0.9); blotters correctly identifying levels above 7% (53 mmol/mol) were 100% for corrected home-blotters and 87% (95% confidence interval) for corrected lab-blotters. NPVs (% blotters correctly identifying levels of 7% or lower [53 mmol/mol]) were 100% for corrected home-blotters and 83% for corrected lab-blotters. After correction, >92% of corrected blotters had errors of 8% or less. Of our subjects, 88.5% found home sampling preferable to routine laboratory sampling.

CONCLUSIONS

Home-blotter collection is an alternative to routine collection.

摘要

目的

糖化血红蛋白(A1C)的定期检测在操作上具有一定难度。家用斑迹滤纸采集提供了一种替代方法。本研究旨在测试家用斑迹滤纸 A1C 测量的可行性。

方法

目的:比较家用斑迹滤纸(home-blotter)和实验室斑迹滤纸(lab-blotter)采集的 A1C 水平与静脉 A1C(常规测量)的准确性。通过 Pearson 相关系数、Lin 一致性相关系数(CCC)、阳性和阴性预测值(PPV、NPV)以及 Bland-Altman 图和相关统计数据评估一致性。

结果

家用斑迹滤纸、实验室斑迹滤纸和静脉 A1C 相关性很强(0.93、0.93)。家用和实验室斑迹滤纸结果均存在向上偏差(0.387%、0.1%)。偏差随时间增加而增加。偏差校正后,两种斑迹滤纸的一致性均得到改善(CCC>0.9);校正后的家用斑迹滤纸正确识别 7%(53mmol/mol)以上水平的比例为 100%,校正后的实验室斑迹滤纸为 87%(95%置信区间)。NPV(%斑迹滤纸正确识别 7%或更低水平[53mmol/mol])校正后的家用斑迹滤纸为 100%,校正后的实验室斑迹滤纸为 83%。校正后,超过 92%的校正斑迹滤纸的误差在 8%以内。在我们的研究对象中,88.5%的人认为家庭采样比常规实验室采样更可取。

结论

家用斑迹滤纸采集是常规采集的一种替代方法。

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