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Reference interval determination for glycated albumin in a Nigerian population Détermination de l'intervalle de référence pour l'albumine glyquée dans une population nigériane
Abstract
Background: Glycated albumin (GA), the non-enzymatic glycation product of circulating albumin, has gained significant attention in the last decades as a biomarker for short-term (2–3 weeks) glycemic control in patients with Diabetes Mellitus (DM). Studies have shown that it may be particularly useful in situations where HbA1c (glycated haemoglobin) test is unreliable or falls short of utility e.g. in haemoglobinopathies, Chronic Kidney Disease, anaemias, pregnancy e.t.c. Studies around the world have been done to establish reference interval for GA in many populations, and because these intervals may vary due to genetic, dietary or environmental factors, it is important to establish one for the Nigerian population to enable accurate utility in DM management.
Objective: This study therefore aims to establish a preliminary reference range for GA in a healthy Nigerian population.
Method: A total of 120 healthy participants were recruited for this study comprising of 36% males and 64% females with mean age of 48±10 years. Venous blood samples were obtained from each participant and analysed for GA using an enzymatic method on Biobase BK-200 auto-analyser, while fasting plasma glucose(FPG) and glycated haemoglobin (HbA1c) estimation was by Hexokinase and TINIA methods respectively on Roche cobas C111 auto-analyser.
Result: The non-parametric method (CLSI C28-A3) for reference range determination was applied. The reference range obtained for GA was 9.5% (lower reference limit) to 18.0% (upper reference limit) at 95% confidence interval (CI).
Conclusion: The reference range for GA obtained from this study is comparable to those reported from other studies and GA can therefore be adopted as a complimentary glycaemic marker in the management of DM.
Contexte de l'étude : L'albumine glyquée (AG), produit de glycation non enzymatique de l'albumine circulante, a suscité une attention significative au cours des dernières décennies en tant que biomarqueur du contrôle glycémique à court terme (2 à 3 semaines) chez les patients atteints de diabète sucré (DS). Des études ont montré qu'elle peut être particulièrement utile dans les situations où le test HbA1c (hémoglobine glyquée) n'est pas fiable ou n'est pas utile, par exemple dans les hémoglobinopathies, les maladies rénales chroniques, les anémies, la grossesse, etc. Des études ont été menées dans le monde entier pour établir un intervalle de référence pour l'AG dans de nombreuses populations, et comme ces intervalles peuvent varier en raison de facteurs génétiques, alimentaires ou environnementaux, il est important d'en établir un pour la population nigériane afin de permettre une utilité précise dans la gestion du DS.
Objectif de l'étude : Cette étude vise donc à établir une plage de référence préliminaire pour l'AG dans une population nigériane en bonne santé.
Méthode de l'étude : Au total, 120 participants en bonne santé ont été recrutés pour cette étude, dont 36 % d'hommes et 64 % de femmes, d'âge moyen de 48 ± 10 ans. Des échantillons de sang veineux ont été prélevés chez chaque participant et analysés pour déterminer l'AG par une méthode enzymatique sur l'auto-analyseur Biobase BK-200, tandis que l'estimation de la glycémie à jeun (FPG) et de l'hémoglobine glyquée (HbA1c) a été effectuée respectivement par les méthodes Hexokinase et TINIA sur l'auto-analyseur Roche cobas C111.
Résultat de l'étude : La méthode non paramétrique (CLSI C28-A3) a été appliquée pour déterminer la plage de référence. La plage de référence obtenue pour l'AG était de 9,5 % (limite de référence inférieure) à 18,0 % (limite de référence supérieure) avec un intervalle de confiance (IC) à 95 %.
Conclusion : La plage de référence pour l'AG obtenue à partir de cette étude est comparable à celles rapportées dans d'autres études et l'AG peut donc être adopté comme marqueur glycémique complémentaire dans la prise en charge du diabète sucré.
