Cargando…

Evaluation of analytical performance of Alinity i system on 31 measurands

INTRODUCTION: Accurate, precise and reliable laboratory test results play a critical role in medical decision making. To satisfy the increasing needs in clinical laboratory tests, the analyzers have been advanced. In this study, authors aimed to evaluate the analytical performance of the Alinity i s...

Descripción completa

Detalles Bibliográficos
Autores principales: Seo, Jong Do, Song, Da Young, Nam, Youngwon, Li, Chihchiao, Kim, Seunghwan, Lee, Joon Hee, Lee, Kyunghoon, Song, Junghan, Song, Sang Hoon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7652776/
https://www.ncbi.nlm.nih.gov/pubmed/33204790
http://dx.doi.org/10.1016/j.plabm.2020.e00185
Descripción
Sumario:INTRODUCTION: Accurate, precise and reliable laboratory test results play a critical role in medical decision making. To satisfy the increasing needs in clinical laboratory tests, the analyzers have been advanced. In this study, authors aimed to evaluate the analytical performance of the Alinity i system (Abbott Laboratories, IL, USA) for diverse analytes measured by using immunoassay principle. MATERIALS AND METHODS: Analytical performance of recently launched Alinity i system has been evaluated for 31 assays in aspects of precision, linearity and analytical measurement range, correlation with the Architect i2000sr system (Abbott Laboratories), carry-over, and reference interval validation in accordance with CLSI guidelines. RESULTS: The within-laboratory CVs of the analytes tested in the study ranged between 1.00 and 7.84%, which met vendor claimed value in precision. In linearity test, most assays satisfied acceptable linearity criteria, best-fit first order regression or polynomial regression with nonlinearity smaller than ±10%, compared with linear regression. The recovery of each analyte distributed from 90.1 to 109.7%. The coefficient of determination (R(2)) for each test was larger than 0.95 except for folate when compared to the results obtained from existing routine analyzer and statistically or clinically equivalent. The carry-over rates were acceptable, and reference intervals were validated. CONCLUSION: Through this study, acceptable analytical performance of novel Alinity i system has been verified. It is expected to readily replace existing instrument and to be an option for laboratories considering introduction of automated immunoassay analyzer.