■近几十年来,由于协作努力,临床实验室结果的分析质量有了显著提高.为了在应用中有效利用实验室结果,比如通过大数据进行机器学习,了解每个测试的协调水平将是有益的。我们旨在开发一个定量的协调指数,以反映现实世界实验室测试的协调状态。
■我们收集了8项测试的2021-2022年外部质量评估(EQA)结果(HbA1c,肌酐,总胆固醇,HDL-胆固醇,甘油三酯,甲胎蛋白[AFP],癌胚抗原[CEA],和前列腺特异性抗原[PSA])。本EQA由韩国外部质量评估服务协会进行,使用可交换的材料。根据对等组内的偏差%和CV%确定每个测试的总分析误差。这些值除以来自生物变异的总允许误差(最小值,可取的,和最优)在每个级别(最低,可取的,和最优)。良好的协调被任意定义为三个级别的RWHI值≤1。
■总胆固醇,甘油三酯,CEA的最优RWHI≤1,表明最优协调水平。具有理想协调水平的测试包括HDL-胆固醇,法新社,PSA。肌酐有最低的协调水平,HbA1c未达到最低协调水平。
■我们使用区域EQA数据开发了定量RWHI。该指数可能有助于反映该领域实验室测试的实际协调水平。
UNASSIGNED: In recent decades, the analytical quality of clinical laboratory results has substantially increased because of collaborative efforts. To effectively utilize laboratory results in applications, such as machine learning through big data, understanding the level of harmonization for each test would be beneficial. We aimed to develop a quantitative
harmonization index that reflects the
harmonization status of real-world laboratory tests.
UNASSIGNED: We collected 2021-2022 external quality assessment (EQA) results for eight tests (HbA1c, creatinine, total cholesterol, HDL-cholesterol, triglyceride, alpha-fetoprotein [AFP], carcinoembryonic antigen [CEA], and prostate-specific antigen [PSA]). This EQA was conducted by the Korean Association of External Quality Assessment Service, using commutable materials. The total analytical error of each test was determined according to the bias% and CV% within peer groups. The values were divided by the total allowable error from biological variation (minimum, desirable, and optimal) to establish a real-world harmonization index (RWHI) at each level (minimum, desirable, and optimal). Good
harmonization was arbitrarily defined as an RWHI value ≤ 1 for the three levels.
UNASSIGNED: Total cholesterol, triglyceride, and CEA had an optimal RWHI of ≤ 1, indicating an optimal harmonization level. Tests with a desirable
harmonization level included HDL-cholesterol, AFP, and PSA. Creatinine had a minimum
harmonization level, and HbA1c did not reach the minimum
harmonization level.
UNASSIGNED: We developed a quantitative RWHI using regional EQA data. This index may help reflect the actual
harmonization level of laboratory tests in the field.