Verification of the analytical performance of the serum albumin assay on the Abbott Alinity ci

Abstract

The objective of this study was to independently evaluate the analytical performance of the albumin assay on the Abbott Alinity ci automated system and to ensure the best reliability of the results according to the recommendations of the NF ISO 15,189 standard.Our study was performed according to the Scope A criteria detailed in the Medical Biology Method Verification/Validation Guide. We evaluated the repeatability and the intermediate precision of the albumin assay. The coefficient of variation obtained by our study were compared with those set by the learned societies (SFBC and RICOS).The High Authority of Health has defined the immunological method as a reference method for the determination of albumin since 2019, hence the unavoidable interest of verification of the colorimetric method before its use for laboratories that do not have the reference method. The results obtained showed a satisfactory repeatability for the 3 levels; low, medium and high with respectively a CV1 = 1.77 %, CV2 = 0.47 % and CV3 = 0.49 %, a satisfactory intra-laboratory reproducibility for the 3 levels; low, medium and high levels with CV1 = 1.76 %, CV2 = 1.86 % and CV3 = 1.32 % respectively. The results obtained allowed us to verify the performance of the method and compare them to the analytical objectives set in order to meet regulatory and normative requirements. The central laboratory of the University Hospital Mohammed VI of Oujda is committed to a quality policy that includes an approach of mastery of the different analytical systems used.