Precision matters: Repeatability and reproducibility of total PSA and homocysteine measurements in Alinity i-system

Abstract

Background: The precision of test measurements is critical in clinical diagnostics, especially for biomarkers like total PSA and homocysteine, which are essential to disease assessment. Using the CMIA approach, this study investigates the repeatability and reproducibility of these biomarkers on the Abbott Alinity system. Methods: The present study was conducted in the clinical chemistry laboratory at Mohammed VI University Hospital of Oujda. The evaluation of the Alinity i-system's analytical performance for total PSA and homocysteine focused on assessing repeatability and intermediate precision. The assessment followed the protocols and guidelines established by the French Accreditation Committee (COFRAC). Results: Our analysis yielded favorable findings regarding the performance of the Alinity assays. The coefficients of variation for both the within-run and between-run precision were less than 5.89% and 4.29%, respectively. These findings produce acceptable outcomes compared to the manufacturer's claims and the SFBC database. Our study underscores the tests' precision, affirming the CMIA method's reliability in measuring total PSA and homocysteine levels. Conclusions: The assessment of the Alinity i-system for total PSA and homocysteine showed significant analytical performance. Our findings have implications for laboratory personnel, researchers, and physicians supporting a continuous diagnostic accuracy improvement culture.