比浊抑制免疫分析法、高效液相色谱法和毛细管电泳法测定糖化血红蛋白的比较。

Comparison of Turbidimetric Inhibition Immunoassay, High-Performance Liquid Chromatography, and Capillary Electrophoresis Methods for Glycated Hemoglobin Determination.

机构信息

Armed Forces Institute of Pathology, Rawalpindi, Pakistan.

Pak Emirates Military Hospital, Rawalpindi, Pakistan.

出版信息

Lab Med. 2020 Nov 2;51(6):579-584. doi: 10.1093/labmed/lmaa010.

DOI:10.1093/labmed/lmaa010

PMID:32219342

Abstract

OBJECTIVE

The purpose of this study was to compare the performances of and evaluate the agreement among glycated hemoglobin values analyzed by using National Glycohemoglobin Standardization Program-certified and International Federation of Clinical Chemistry-standardized analyzers.

THIS CROSS-SECTIONAL STUDY WAS CONDUCTED AT THE: Armed Forces Institute of Pathology, Department of Chemical Pathology from March 2019 to May 2019.

METHODS

Glycated hemoglobin (HbA1c) was measured in the blood specimens from 100 patients on an ADVIA 1800 by a turbidimetric inhibitory immunoassay (TINIA), Sebia instrument by electrophoresis, and Bio-Rad Variant II Turbo system by high-performance liquid chromatography (HPLC). Quantitative variables were calculated as the mean ± standard deviation (SD). Precision and method comparisons were carried out according to Clinical and Laboratory Standards Institute recommendations. The results obtained from each analyzer were compared by correlation analysis. Method comparison was done by linear regression and Bland-Altman plots using the SPSS software version 24.

RESULTS

The mean ± SD HbA1c values from TINIA, electrophoresis, and HPLC were 7.188% ± 1.89%, 7.164% ± 1.866%, and 7.160% ± 1.85%, respectively. The between-run coefficients of variation for TINIA, electrophoresis, and HPLC were 0.64%, 0.61%, and 0.60%, respectively. All 3 showed good correlation (TINIA, R2 = .994, P = .00; electrophoresis, R2 = .992, P = 0.00; and HPLC, R2 = .994, P = 0.00).

CONCLUSION

The good clinical agreements of HbA1c and strong correlations between analyzers indicate that these analyzers can be used interchangeably.

摘要

目的

本研究旨在比较并评估经美国国家糖化血红蛋白标准化计划认证和国际临床化学标准化联合会标准化分析仪分析的糖化血红蛋白值的性能和一致性。

本横断面研究于 2019 年 3 月至 2019 年 5 月在武装部队病理研究所化学病理学系进行。

方法

采用比浊抑制免疫测定法（TINIA）、塞比亚仪器电泳法和伯乐变异 II 涡轮高效液相色谱法（HPLC）对 100 例患者的血液标本进行糖化血红蛋白（HbA1c）测定。定量变量计算为平均值±标准差（SD）。根据临床和实验室标准协会的建议进行精密度和方法比较。使用 SPSS 软件版本 24 通过相关分析比较每个分析仪获得的结果。通过线性回归和 Bland-Altman 图进行方法比较。

结果

TINIA、电泳和 HPLC 法的 HbA1c 值的平均值±SD 分别为 7.188%±1.89%、7.164%±1.866%和 7.160%±1.85%。TINIA、电泳和 HPLC 的批内变异系数分别为 0.64%、0.61%和 0.60%。所有 3 种方法均显示出良好的相关性（TINIA，R2 =.994，P =.00；电泳，R2 =.992，P =.00；HPLC，R2 =.994，P =.00）。