RESUMEN
The Sysmex(®) CS-2100i is a fully automated multiparameter hemostasis analyzer equipped with a photo-optical clot detection unit, a cap-piercing system and a pre-analytical check screens for interfering substances such as bilirubin, lipids and haemolysis (HIL system). It is designed to perform coagulation tests as well as chromogenic and immunologic assays. The aim of the present study was to evaluate its performance. The tests performed were routine coagulation (prothrombin time, activated partial thromboplastin time, fibrinogen, factor VIII and factor V), chromogenic (antithrombin) and immunologic assays (D-Dimer). The intra-assay and inter-assay coefficients of variation (CV) were below 5% for most parameters both in the normal and in the pathological range (exceptions: intra-assay CV = 5.65% for the fibrinogen in the low range of concentrations; and inter-assay CV = 6% for clotting factor). The measured lower limits of linearity for factor VIII and factor V were satisfactory. No sample or reagent carryover was detected in the conditions of the study. Our results demonstrated that using the CS-2100i analyzer, routine coagulation testing can be performed with satisfactory precision.
Asunto(s)
Automatización de Laboratorios , Hematología/métodos , Ensayos Analíticos de Alto Rendimiento/instrumentación , Ensayos Analíticos de Alto Rendimiento/métodos , Antitrombina III/análisis , Factores de Coagulación Sanguínea/análisis , Pruebas de Coagulación Sanguínea/instrumentación , Pruebas de Coagulación Sanguínea/métodos , Pruebas de Coagulación Sanguínea/normas , Pruebas Diagnósticas de Rutina/instrumentación , Pruebas Diagnósticas de Rutina/métodos , Contaminación de Equipos/estadística & datos numéricos , Factor VIII/análisis , Fibrinógeno/análisis , Hematología/instrumentación , Ensayos Analíticos de Alto Rendimiento/normas , Humanos , Juego de Reactivos para Diagnóstico , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Factores de TiempoRESUMEN
The Sysmex® CS-5100 is a fully automated multiparameter hemostasis analyzer equipped with a photo-optical clot detection unit, a cap-piercing system and a pre-analytical check screens for interfering substances such as bilirubin, lipids and haemolysis (HIL system). It is designed to perform coagulation tests as well as coagulometric, chromogenic and immunologic assays. The aim of the present study was to evaluate its performance. The intra-assay and inter-assay coefficients of variation (CV) were below 6% for most parameters both in the normal and in the pathological range (exceptions: intra-assay for severe factor VIII deficiency (CV = 7.4%) and for vWFRco (CV = 7.3% and 7.7%); and inter-assay for anti-Xa activity (CV = 8.8%) and vWFRco (9.3% and 11.1%). The measured lower limits of linearity for factor VIII and factor V were satisfactory. No sample or reagent carryover was detected in the conditions of the study. Our results demonstrated that using the Sysmex® CS-5100 analyzer, routine coagulation testing can be performed with satisfactory precision. This automate has the advantage of being connectable to an automation chain.