Abstract
Background and objectiveHigh Performance Liquid Chromatography (HPLC) technique is considered as a gold standard for HbA1c analysis however all laboratories cannot adopt it due to certain limitations. Our aim was to compare Particle Enhanced Immunoturbidimetry (PEIT) method with High Performance Liquid Chromatography (HPLC) for HbA1c analysis.MethodAll blood samples were analyzed by HPLC assay on a Bio-Rad D-10 analyzer and PEIT on an Erba XL-200 analyzer. Precision studies were undertaken and Coefficient of Variation (%CV) calculated. Systemic Error (SE), Random Error (RE) and Total Error (TEcalc) were obtained. The Total Allowable Error (TEa) set by the National Glycohemoglobin Standardization Program (NGSP) for HbA1c is 6%.The acceptable evaluation method is where TEcalc is less than TEa.ResultsThe Precision studies were satisfactory with Coefficient of Variation (%CV) being less than 4% for both techniques. Mean HbA1c levels were slightly higher from HPLC than PEIT 9.07 ± 2.23% and 8.93 ± 2.10% respectively, although the difference was minimal. RE was 1.41%, TEcalc was 1.55%, which was less than TEa set by the NGSP. Both methods strongly correlated with the correlation coefficient (r) 0.9716, p < 0.0001.ConclusionOur study showed HbA1c analysis by PEIT technique is precise, accurate, rapid and convenient and can be employed as an alternative to HPLC technique in countries where cost is a major problem for diagnosis and treatment.
Highlights
Diabetes is highly prevalent in both developing and developed countries
Our study showed Glycated hemoglobin (HbA1c) analysis by Particle Enhanced Immunoturbidimetry (PEIT) technique is precise, accurate, rapid and convenient and can be employed as an alternative to High Performance Liquid Chromatography (HPLC) technique in countries where cost is a major problem for diagnosis and treatment
The aim of this study was to perform the method comparison of the Particle Enhanced Immunoturbidimetry (PEIT) on an Erba XL-200 with High performance liquid chromatography (HPLC) and on a Bio-Rad-D10 analyzer for HbA1c analysis
Summary
Diabetes is highly prevalent in both developing and developed countries. National Diabetes Survey of Pakistan (NDSP 2016–2017) has reported the prevalence of diabetes as 26.3% in Pakistan [1]. Several analytical methods have been developed for HbA1c analysis. The National Glycohemoglobin Standardization Program (NGSP) improves the quality of HbA1c testing. ADA recommends that laboratories should use NGSP-certified methods for HbA1c analysis [7, 8]. Notwithstanding all these quality improvement measures, there is a degree of inter-method variability among NGSP-certified methods. Various laboratory methods are available to measure HbA1c in blood. High Performance Liquid Chromatography (HPLC) technique is considered as a gold standard for HbA1c analysis all laboratories cannot adopt it due to certain limitations. Our aim was to compare Particle Enhanced Immunoturbidimetry (PEIT) method with High Performance Liquid Chromatography (HPLC) for HbA1c analysis
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