Performance Evaluation of Sysmex CN-3000 and Stago STA R Max Coagulation Analyzers and Interference of Hemolysis

Abstract

Background: In this study, our purpose was to evaluate the analytical performances of the STA R Max and CN-3000, and compare the results of both for PT, aPTT, fibrinogen, D-dimer, and factor VIII, and also to show the influence of hemolysis on PT, aPTT, and fibrinogen assays. Methods: Three hundred ninety-five randomly-selected blood samples from residual material from Istanbul Fac-ulty of Medicine, Central Laboratory workflow comprised the study group. PT, aPTT, fibrinogen, D-dimer, and factor VIII activity were done using both analyzers. Analytical performances were determined through precision, linearity, and comparability studies. Artificial hemolysis was performed through freezing-thawing and mechani-cal-sheer methods. Results: Intra-assay and between-day CVs% of PT and aPTT were lower than 5% for STA R Max and CN-3000. Only the within-run and between-day CVs% of fibrinogen and the between-day CVs% of D-dimer were higher than 5%, but in acceptable targets. Intra-assay and between-day CVs% of FVIII on the CN-3000 were 3.5% and 12.3% at the low and 2.5% and 5.3% at high level, and 1.8% and 3.7% at the low and 6.3% and 5.9% at high level on the STA R Max. The comparison results of PT, aPTT, fibrinogen, and D-dimer were good (r > 0.91), also good correlations were obtained for FVIII activity > 40 IU/dL and FVIII between 5 -40 IU/dL (r = 0.89). The results of the hemolysis study were within acceptable limits of the recommended criteria of Fraser and the manu-facturer. Conclusions: CN-3000 and STA R Max coagulation analyzers are accurate and highly precise systems for safe use in clinical diagnostic applications. The interferences obtained for both analyzers were found to be within accepted targets. (Clin. Lab. 2022;68:xx-xx. DOI: 10.7754/Clin.Lab.2021.210501)