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首页> 外文期刊>Clinical Chemistry: Journal of the American Association for Clinical Chemists >Statistical Methods for Monitoring the Relationship between the IFCC Reference Measurement Procedure for Hemoglobin A1c and the Designated Comparison Methods in the United States, Japan, and Sweden
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Statistical Methods for Monitoring the Relationship between the IFCC Reference Measurement Procedure for Hemoglobin A1c and the Designated Comparison Methods in the United States, Japan, and Sweden

机译：监测美国，日本和瑞典的IFCC血红蛋白A1c参考测量程序与指定比较方法之间的关系的统计方法

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Background: The American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD)/International Diabetes Federation (IDF)/IFCC Consensus Statement on the worldwide standardization of HbA1c states that “… [HbA1c] results are to be reported world-wide in IFCC units … and derived NGSP units … , using the IFCC-NGSP master equation.”Methods: We describe statistical methods to evaluate and monitor the relationships as expressed in master equations (MEs) between the IFCC Reference Measurement procedure (IFCC-RM) and designated comparison methods (DCMs) [US National Glycohemoglobin Standardization Program (NGSP), Japanese Diabetes Society/Japanese Society for Clinical Chemistry (JDS/JSCC), and Mono-S in Sweden]. We applied these statistics, including uncertainty calculations, to 12 studies in which networks of reference laboratories participated, operating the IFCC-RM and DCMs.Results: For NGSP and Mono-S, slope, intercept, and derived percentage HbA1c at the therapeutic target show compliance with the respective MEs in all 12 studies. For JDS/JSCC, a slight deviation is seen in slope and derived percentage HbA1c in 2 of the 12 studies. Using the MEs, the uncertainty in an assigned value increases from 0.42 mmol/mol HbA1c (IFCC-RM) to 0.47 (NGSP), 0.49 (JDS/JSCC), and 0.51 (Mono-S).Conclusions: We describe sound statistical methods for the investigation of relations between networks of reference laboratories. Application of these statistical methods to the relationship between the IFCC-RM and DCMs in the US, Japan, and Sweden shows that they are suitable for the purpose, and the results support the applicability of the ADA/EASD/IDF/IFCC Consensus Statement on HbA1c measurement.
机译：背景：美国糖尿病协会（ADA）/欧洲糖尿病研究协会（EASD）/国际糖尿病联合会（IDF）/ IFCC关于HbA1c在全球范围内标准化的共识声明指出，“…[HbA1c]结果应在世界范围内报道。方法：我们描述了统计方法，用于评估和监视IFCC参考测量程序（IFCC-）之间以主方程（ME）表示的关系。 RM）和指定的比较方法（DCM）[美国国家糖化血红蛋白标准化计划（NGSP），日本糖尿病学会/日本临床化学学会（JDS / JSCC）和瑞典的Mono-S]。我们将这些统计数据（包括不确定性计算）应用于参考实验室网络参与，运行IFCC-RM和DCM的12个研究中。结果：对于NGSP和Mono-S，斜率，截距和导出的治疗靶点HbA1c百分比显示在所有12项研究中均符合各自的ME。对于JDS / JSCC，在12项研究中的2项中，斜率和推导的HbA1c百分数可见轻微偏差。使用ME，指定值的不确定性从0.42 mmol / mol HbA1c（IFCC-RM）增至0.47（NGSP），0.49（JDS / JSCC）和0.51（Mono-S）。结论：我们描述了可靠的统计方法用于调查参考实验室网络之间的关系。将这些统计方法应用于美国，日本和瑞典的IFCC-RM和DCM之间的关系表明，它们很适合此目的，其结果支持ADA / EASD / IDF / IFCC共识声明的适用性。 HbA1c测量。

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