Verification of the Analytical Performance of the Ige Assay on Abbott Architect Ci8200

Measurements of IgE are useful to carry out on a routine basis for diagnosis, postoperative monitoring and assessment of treatment of the atopy-associated diseases such as atopic asthma, rhinitis and dermatitis etc., as well as of the infectious diseases, caused by parasites and of the IgE-myeloma. The objective of this study was to independently evaluate the analytical performance of the IgE assay on the Abbott Architect ci8200 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 IgE assay. The coefficients of variation obtained by our study were compared with those set by SFBC. The results obtained showed a satisfactory repeatability for the 2 levels; low and high with respectively CV1 = 3.85 % and CV2 = 1.56 %, a satisfactory intra-laboratory reproducibility for the 2 levels; low and high with CV1 = 7.48 % and CV2 = 5.19 % % 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.