Performance Evaluation of Sysmex CN-3000 and Stago STA R Max Coagulation Analyzers and Interference of Hemolysis. 2022

Murat Kaytaz, and Emre Akkaya, and Beyhan Omer, and Sema Genc

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 Faculty 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 mechanical-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 manufacturer. 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.

UI MeSH Term Description Entries
D007753 Laboratories Facilities equipped to carry out investigative procedures. Laboratory
D010314 Partial Thromboplastin Time The time required for the appearance of FIBRIN strands following the mixing of PLASMA with phospholipid platelet substitute (e.g., crude cephalins, soybean phosphatides). It is a test of the intrinsic pathway (factors VIII, IX, XI, and XII) and the common pathway (fibrinogen, prothrombin, factors V and X) of BLOOD COAGULATION. It is used as a screening test and to monitor HEPARIN therapy. Activated Partial Thromboplastin Time,Cephalin-Kaolin Coagulation Time,Kaolin-Cephalin Coagulation Time,Thromboplastin Time, Partial,Coagulation Time, Cephalin-Kaolin,Cephalin Kaolin Coagulation Time,Coagulation Time, Cephalin Kaolin,Coagulation Time, Kaolin-Cephalin,Kaolin Cephalin Coagulation Time
D001777 Blood Coagulation The process of the interaction of BLOOD COAGULATION FACTORS that results in an insoluble FIBRIN clot. Blood Clotting,Coagulation, Blood,Blood Clottings,Clotting, Blood
D001780 Blood Coagulation Tests Laboratory tests for evaluating the individual's clotting mechanism. Coagulation Tests, Blood,Tests, Blood Coagulation,Blood Coagulation Test,Coagulation Test, Blood,Test, Blood Coagulation
D006461 Hemolysis The destruction of ERYTHROCYTES by many different causal agents such as antibodies, bacteria, chemicals, temperature, and changes in tonicity. Haemolysis,Extravascular Hemolysis,Intravascular Hemolysis,Extravascular Hemolyses,Haemolyses,Hemolyses, Extravascular,Hemolyses, Intravascular,Hemolysis, Extravascular,Hemolysis, Intravascular,Intravascular Hemolyses
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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