On behalf of the Association of High Complexity Laboratories (Asociación de Laboratorios de Alta Complejidad - ALAC) Study Group*, CABA Argentina.
On behalf of the Argentine Diabetes Society (Sociedad Argentina de Diabetes - SAD), CABA Argentina.
J Diabetes Sci Technol. 2022 May;16(3):724-731. doi: 10.1177/1932296821997179. Epub 2021 Mar 9.
HbA1c result provide information on metabolic control in diabetes mellitus (DM) and could also be used for its diagnosis. For its determination, the laboratory must be certified by the National Glycohemoglobin Standardization Program (NGSP) or the International Federation of Clinical Chemistry (IFCC) and comply with a strict quality control program.
To determine the correlation and agreement between HbA1c results measured by three analytical methods (enzymatic, turbidimetric, and capillary electrophoresis) versus HPLC.
Method comparison-1245 samples from equal number of subjects at 45 Association of High Complexity Laboratories (Asociación de Laboratorios de Alta Complejidad-ALAC) centers, centralizing sample processing and operator. Statistical analysis-analysis of variance (ANOVA) and nonparametric Friedman ANOVA test for related samples, means, and medians. Correlation and concordance-Pearson's correlation and linear regression, intraclass correlation coefficient (Passing and Bablock and Bland and Altman).
The comparison of mean values obtained by the four methods showed statistically significant, but clinically irrelevant, differences: HbA1c by HPLC versus Electrophoresis 0.06% (0.42 mmol/mol) = .000 (± 1.96 DS -0.070 -0.047), Enzymatic 0.087% (1 mmol/mol) = .000 (± 1.96 DS 0.077 0.098), Turbidimetric 0.056% (0.38 mmol/mol) = 0.000 (± 1.96 DS -0.067 -0.044). Their concordance showed intraclass correlation of single measures of 0.982 < .001 (95% CI 0.987 - 0.9838).
The three methods present low variability and high correlation versus the HPLC.
HbA1c 结果可提供糖尿病（DM）代谢控制的信息，也可用于其诊断。为了进行测定，实验室必须经过国家糖化血红蛋白标准化计划（NGSP）或国际临床化学联合会（IFCC）认证，并符合严格的质量控制计划。
确定三种分析方法（酶法、比浊法和毛细管电泳法）与 HPLC 测量的 HbA1c 结果之间的相关性和一致性。
方法比较-45 个高复杂度实验室（Asociación de Laboratorios de Alta Complejidad-ALAC）中心的等量受试者的 1245 个样本，集中处理样本和操作人员。统计分析-方差分析（ANOVA）和非参数 Friedman ANOVA 检验用于相关样本、均值和中位数。相关性和一致性-Pearson 相关性和线性回归、组内相关系数（Passing 和 Bablock、Bland 和 Altman）。
四种方法的均值比较显示有统计学意义，但临床意义不大的差异：HPLC 与电泳法相比 HbA1c 0.06%（0.42mmol/mol）=0.000（±1.96DS-0.070-0.047），酶法 0.087%（1mmol/mol）=0.000（±1.96DS 0.077 0.098），比浊法 0.056%（0.38mmol/mol）=0.000（±1.96DS-0.067-0.044）。它们的一致性显示单测的组内相关系数为 0.982 <.001（95%CI 0.987-0.9838）。
三种方法与 HPLC 相比具有低变异性和高相关性。
