Comparison between estradiol measured by immunoassay on Abbott's ISR2 vs. Liquid chromatography tandem mass spectrometry
Comparaison de méthode entre l'estradiol dosé en immunodosage sur l'Architect d'Abbott versus la chromatographie liquide couplée à de la spectrométrie de masse en tandem
Abstract
Context: it is becoming more and more necessary to measure estradiol (E2) levels in a sensitive and precise manner in patients with E2-related endocrine disorders, particularly in the pediatric population. Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is recognized as a reliable and accurate method for measuring steroid hormone levels. In this study, we developed an LC-MS/MS method to quantify serum E2 concentrations and compared it with the routine immunoassay method used at Bordeaux University Hospital. Method: the method validation was based on validation criteria such as specificity, determination of the limit of quantification (LOQ), linearity, intermediate precision, repeatability, and correlation to compare the two methods. Results: although most criteria were met for the quantification of serum E2 by LC-MS/MS, this method showed limitations at low concentrations, particularly in terms of LOQ compared to other LC-MS/MS methods reported in the literature. Conclusion: we confirm the superiority of the LC-MS/MS method over immunoassay for E2 measurement. However, further optimization trials Context: It is becoming more and more necessary to measure estradiol (E2) levels in a sensitive and precise manner in patients with E2-related endocrine disorders, particularly in the pediatric population. Liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) is recognized as a reliable and accurate method for measuring steroid hormone levels. In this study, we developed an LC-MS/MS method to quantify serum E2 concentrations and compared it with the routine immunoassay method used at Bordeaux University Hospital. Method: The method validation was based on validation criteria such as specificity, determination of the limit of quantification (LOQ), linearity, intermediate precision, repeatability, and correlation to compare the two methods. Results: Although most criteria were met for the quantification of serum E2 by LC-MS/MS, this method showed limitations at low concentrations, particularly in terms of LOQ compared to other LC-MS/MS methods reported in the literature. Conclusion: we confirm the superiority of the LC-MS/MS method over immunoassay for E2 measurement. However, further optimization trials will be necessary before considering its routine implementation at Bordeaux University Hospital.
Contexte : il devient de plus en plus nécessaire de mesurer de manière sensible et précise les niveaux d'estradiol (E2) chez les patients atteints de troubles endocriniens liés à l'E2, et notamment dans la population pédiatrique. La chromatographie liquide couplée à la spectrométrie de masse en tandem (LC-MS/MS) est une méthode reconnue comme fiable et précise pour mesurer les niveaux d'hormones stéroïdiennes. Dans cette étude, nous avons développé une méthode LC-MS/MS pour quantifier les concentrations sériques d'E2 et la comparer à la méthode de routine du CHU de Bordeaux qu’est l’immunodosage. Méthode : la validation de méthode a reposé sur les critères de validation tels que la spécificité, la détermination de la limite de quantification (LOQ), la linéarité, la fidélité intermédiaire, la répétabilité ainsi qu’une corrélation pour comparer les deux méthodes. Résultats : bien que la plupart des critères ont été validé pour la quantification de l’E2 sérique par LC-MS/MS, cette méthode a présenté des limitations à faible concentration, notamment en termes de LOQ quand on la compare aux autres méthodes de LC-MS/MS dans la littérature. Conclusion : nous confirmons ici la supériorité de la méthode LC-MS/MS par rapport à l’immunodosage pour le dosage de l’E2. Néanmoins, il sera nécessaire de réaliser des essais supplémentaires d’optimisation avant d’envisager de pouvoir la mettre en place en routine au CHU de Bordeaux.