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This study meticulously assessed the analytical performance of iron determination on the Alinity ci® analyzer, employing advanced AI-powered method verification techniques. Conducted at Mohammed VI University Hospital's central laboratory in Oujda, Morocco, the validation process strictly adhered to the rigorous guidelines outlined in the French accreditation committee's (COFRAC) Accreditation Technical Guide (GTA) 04. Through comprehensive assessments of repeatability and reproducibility, we definitively confirmed the assay's precision and reliability. Our evaluation yielded highly satisfactory results, consistently exceeding the established criteria set forth by both the instrument manufacturer and esteemed professional organizations like SFBC and RICOS. This unequivocally validates the laboratory's capability to deliver accurate and reproducible iron concentration measurements, crucial for enhanced clinical diagnostics and, ultimately, well-informed patient care decisions. This study underscores the importance of stringent validation processes in ensuring the reliability of diagnostic assays, thereby bolstering confidence in laboratory medicine practices and patient outcomes.
Halas et al. (Tue,) studied this question.
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