External Quality Assessment of Glycated Hemoglobin in Iran: Comparison of Five Different Commercial Methods with Two Different Total Allowable Errors.

Fereshteh Atabi,Reza Mohammadi

doi:10.1515/jomb-2017-0057

Abstract

SummaryBackgroundGlycated hemoglobin (HbA1c) measuring has a critical role in the monitoring and diagnosis of diabetes. So, the analytical performance of its measuring method must be acceptable. Clinical laboratories should continuously monitor the performance of their commercial methods, both by using proper internal quality control (IQC) and by participating in external quality assessment schemes (EQAS).MethodsIn January and August 2016, two different freshly prepared commutable patient QC samples were sent to over 1000 laboratories, but 682 and 925 different laboratories which were used five common commercial methods for measuring HbA1c, included in this study during 23th and 24th runs of the external quality assessment program (EQAP), respectively. Target values for total group and also for peer groups were calculated. The performance of each method and laboratory were determined according to two different allowable total errors (TEa), including ±6% and ±20%, which are suggested by the National Glycohemoglobin Standardization Program (NGSP) and Reference Health Laboratory of Iran, respectively.ResultsConsidering TEa of ±20% in evaluating HbA1c commercial methods and laboratory performances, pass rates ranged from 97% to 98% during EQAP-23 and EQAP-24, respectively. But when this evaluation was performed according to TEa of ±6%, pass rates decreased significantly to 60% and 62%, respectively.ConclusionsUsing improper analytical goals has led to misinterpretation of EQA results. In order to maintain the clinical usefulness of HbA1c results, we need to reduce TEa of ±20% to ±6% and improve HbA1c measuring method performance. Although, with TEa of ±6% our pass rates are not so bad.

Highlights

According to the critical role of the level of glycated hemoglobin (HbA1c) in the monitoring and diagnosis of diabetes [1, 2] the acceptable precision and accuracy of different commercial methods in clinical laboratories for measuring HbA1c is essential [3]
It is the responsibility of clinical laboratories to monitor the performance of their methods, both by using a proper internal quality control (IQC) and participating in external quality assessment schemes (EQAS) [3]
In each above experiment, including IQC, EQAS, and method validation, judgement of method performance acceptability depends on the established allowable total error (TEa)

Summary

Introduction

According to the critical role of the level of glycated hemoglobin (HbA1c) in the monitoring and diagnosis of diabetes [1, 2] the acceptable precision and accuracy of different commercial methods in clinical laboratories for measuring HbA1c is essential [3]. The manufacturers should produce commercial methods that their results could be traceable to the higher-order references and be able to achieve acceptable analytical goals of measurement [3]. Before routinely using any commercial methods for analyzing patient specimens, each laboratory should verify method producer claims or validate method performance according to the laboratory analytical goals [4]. In each above experiment, including IQC, EQAS, and method validation, judgement of method performance acceptability depends on the established allowable total error (TEa). TEa is a maximum tolerable error that, if it occurs, will not impair the result’s clinical usefulness [5,6,7]

Methods

Results

Discussion

Conclusion