International Journal of Medical Laboratory Research (IJMLR)

VERIFICATION OF ANALYTICAL PERFORMANCE OF FSH ASSAY ON THE ABBOTT ARCHITECT CI®: EXPERIENCE OF THE CENTRAL LABORATORY OF MOHAMMED VI UNIVERSITY HOSPITAL OF OUJDA

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N Ikhlass, E Dounia, El H Sebbar, M Choukri

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ABSTRACT:

Verification of analytical methods is a fundamental requirement for ensuring the accuracy, precision, and reliability of laboratory results, particularly for clinically important biomarkers such as follicle-stimulating hormone (FSH). This study evaluates the analytical performance of the FSH assay performed using chemiluminescent microparticle immunoassay (CMIA) on the ABBOTT ARCHITECT Ci analyzer in the central laboratory of Mohammed VI University Hospital. The verification process included two phases: assessment of intermediate precision over a 30-day period using three levels of internal quality control, and evaluation of repeatability based on 30 consecutive measurements for three concentration levels. Intermediate precision showed coefficients of variation (CVs) of 5.55%, 6.27%, and 9.08%, while repeatability demonstrated excellent performance with CVs of 3.96%, 3.19%, and 2.22% across low, medium, and high levels, respectively. All results met the acceptance criteria defined by RICOS and FSCB. These findings confirm that the CMIA FSH assay provides reliable, reproducible, and clinically robust measurements. Incorporating this verification into routine practice strengthens the laboratory’s quality management system and ensures that FSH results are accurate, reproducible, and directly supportive of clinical decision-making.

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Keywords: FSH; Analytical performance; Repeatability; Reproducibility; Architect ABOTT   Ci Analyzer; CMIA.Alinityi®

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