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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：在美国，日本和瑞典，用于监测IFCC血红蛋白A1c参考测量程序与指定比较方法之间关系的统计方法。

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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 HbA(1c) states that "... [HbA(1c)] 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 HbA(1c) 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 HbA(1c) in 2 of the 12 studies. Using the MEs, the uncertainty in an assigned value increases from 0.42 mmol/mol HbA(1c) (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HbA（1c）全球标准化的共识声明指出：“ ... [HbA（1c ）]的结果将以IFCC-NGSP主方程式以IFCC单位...和衍生的NGSP单位...在全球范围内报告。”方法：我们描述了统计方法，用于评估和监测IFCC参考测量程序（IFCC-RM）与指定的比较方法（DCM）之间以主方程（ME）表示的关系[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。结果：对于NGSP和Mono-S，在所有12项研究中，治疗目标处的斜率，截距和推导百分数HbA（1c）均符合各自的ME。对于JDS / JSCC，在12项研究中的2项中，斜率和派生百分比HbA（1c）略有偏差。使用ME，指定值的不确定度从0.42 mmol / mol HbA（1c）（IFCC-RM）增加到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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