RESUMO
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.
Assuntos
Automação Laboratorial , Hematologia/métodos , Ensaios de Triagem em Larga Escala/instrumentação , Ensaios de Triagem em Larga Escala/métodos , Antitrombina III/análise , Fatores de Coagulação Sanguínea/análise , Testes de Coagulação Sanguínea/instrumentação , Testes de Coagulação Sanguínea/métodos , Testes de Coagulação Sanguínea/normas , Testes Diagnósticos de Rotina/instrumentação , Testes Diagnósticos de Rotina/métodos , Contaminação de Equipamentos/estatística & dados numéricos , Fator VIII/análise , Fibrinogênio/análise , Hematologia/instrumentação , Ensaios de Triagem em Larga Escala/normas , Humanos , Kit de Reagentes para Diagnóstico , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Fatores de TempoRESUMO
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.