在Bio-Rad Variant II上对血红蛋白A(1c)双试剂盒检测法的分析评估：一种用于糖尿病患者管理的自动化高效液相色谱血红蛋白分析仪

Analytical evaluation of hemoglobin A(1c) dual kit assay on Bio-Rad Variant II: an automated HPLC hemoglobin analyzer for the management of diabetic patients.

作者信息

Moridani Majid Y, Verjee Zul, Allen Lynn C

机构信息

Toronto Medical Laboratories, St. Patrick Site, University Health Network, 222 St Patrick Street, M5T 1V4, Toronto, Ontario, Canada.

出版信息

Clin Biochem. 2003 Jun;36(4):317-20. doi: 10.1016/s0009-9120(03)00013-4.

DOI:10.1016/s0009-9120(03)00013-4

PMID:12810162

Abstract

OBJECTIVES

To evaluate the analytical performance of the Bio-Rad Variant II HbA(1c) dual kit assay.

DESIGN AND METHODS

Precision, carryover, linearity and analytical range were investigated. 139 patients' HbA(1c) results analyzed by the Variant II were compared to the Variant I method. 49 blood samples analyzed by the Variant II at Toronto Medical Laboratories (TML) were compared to the Variant II at Hospital for Sick Children (HSC).

RESULTS

Total imprecision was less than 2% for the Variant II assay. The method had a wide analytical range with no carryover. HbA(1c) results were not changed after switching back and forth from the beta thalassemia to HbA(1c) assay. The Variant II showed an average of 0.0027 negative bias compared to the Variant I method. There was an average of 0.0020 negative bias for HbA(1c) results on the Variant II at TML compared to the Variant II at HSC.

CONCLUSIONS

HbA(1c) analysis on the Variant II HbA(1c) dual kit is a relatively fast and reproducible method.

摘要

目的

评估伯乐Variant II HbA(1c) 双试剂盒检测法的分析性能。

设计与方法

研究了精密度、携带污染、线性和分析范围。将通过Variant II分析的139例患者的HbA(1c)结果与Variant I方法进行比较。将多伦多医学实验室（TML）通过Variant II分析的49份血样与病童医院（HSC）的Variant II进行比较。

结果

Variant II检测法的总不精密度小于2%。该方法具有较宽的分析范围且无携带污染。从β地中海贫血检测转换为HbA(1c)检测后，HbA(1c)结果未发生变化。与Variant I方法相比，Variant II平均有0.0027的负偏差。与HSC的Variant II相比，TML的Variant II上HbA(1c)结果平均有0.0020的负偏差。