Abstract
ObjectivesThis study compared the new high-volume blood coagulation analyzer Sysmex CS-5100 System™ (Siemens Healthcare Diagnostics, Erlangen, Germany) to the mid-volume blood coagulation analyzer Sysmex CS-2000i System™ (Siemens) for analytical performance. Additionally, the operational performance of the Sysmex CS-5100 System was compared with the blood coagulation analyzer ACL TOP 700 (Instrumentation Laboratory, Werfen Group, Kirchheim bei Munchen, Germany). Materials and methodsWe compared the Sysmex CS-5100 to the Sysmex CS-2000i and the ACL TOP analyzer for routine coagulation, chromogenic and immunological assays. Imprecision studies were performed for the Sysmex CS-5100 and Sysmex CS-2000i systems. A throughput and STAT analysis comparison of the CS-5100 and the ACL TOP was performed. A stress test was performed to characterize the robustness and the error rate of the CS-5100. We also performed correlation analysis between the CS-5100 and the CS-2000i or the ACL TOP in the measurement of patients’ samples. ResultsThe inter-assay precision using the CS systems was impressive (inter-assay CV generally <3.5%) and the correlation between the two Sysmex analyzers was excellent. In the throughput study, the CS-5100 completed the measurement of 100 samples (210 results) in less than 49min. ConclusionsOur results demonstrated that the CS-5100 is a robust high-throughput analyzer, well-suited for coagulation laboratories.
Highlights
Current requirements in the hemostasis laboratory include optimal diagnostic performance, improved quality management, and efficient work-flow
Our results demonstrated that the CS-5100 is a robust high-throughput analyzer, well-suited for coagulation laboratories
Blood was centrifuged for 10 min at 3000×g for prothrombin time (PT), partial thromboplastin time (PTT), antithrombin (AT), fibrinogen (Fib) and D-dimer
Summary
Current requirements in the hemostasis laboratory include optimal diagnostic performance, improved quality management, and efficient work-flow. With the growing number of samples which a laboratory must handle, a fast, precise and robust analyzer is essential. Any new analyzer should require minimal operational and maintenance time, and have a small sample and dead volume in order to analyze pediatric samples. In modern laboratories most analyzers used for clinical chemistry, hematology and hemostaseology are automated for shorter turn-around-time (TAT) (especially for samples from the emergency room and intensive care unit) and to minimize the personnel needed to operate them Any new coagulation analyzer must be compatible with such systems for measuring the standard parameters (PT, PTT, fibrinogen, antithrombin, d-dimer). In laboratories associated with blood transfusion services, the precise measurement of single-factor activity is necessary to obtain all the official licenses required. The system should perform more specific assays e.g. Protein C, Protein S, von Willebrand assays
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