The Sysmex CS-5100 coagulation analyzer offers comparable analytical performance and excellent throughput capabilities

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 49 min.ConclusionsOur results demonstrated that the CS-5100 is a robust high-throughput analyzer, well-suited for coagulation laboratories.

Evaluating the analytical performance of five new coagulation assays for the measurement of prothrombin time and activated thromboplastin time

“…The reference range in apparently healthy volunteers measured with the aPTT assay was consistent with those previously reported for other assays/platforms, and the reference ranges for the aPTT Lupus and aPTT Screen assays were in line with those of the aPTT assay. The reference range for the PT Rec assay (8.4‐10.6 seconds) was slightly lower than that previously reported for similar assays . Reference ranges for each assay were consistent whether fresh or frozen samples were used, and with two different types of sample tube.…”

“…The reference range for the PT Rec assay (8.4-10.6 seconds) was slightly lower than that previously reported for similar assays. 34,37 Reference ranges for each assay were consistent whether fresh or frozen samples were used, and with two different types of sample tube.…”

Evaluating the analytical performance of four new coagulation assays for the measurement of fibrinogen, D‐dimer and thrombin time

“…Overall, the CVs for all four assays were ≤4.1% for within‐run precision and ≤8.6% for total reproducibility; lot‐to‐lot comparisons with each assay showed a high level of consistency across all sites. The fibrinogen, PT‐derived fibrinogen, and D‐dimer assays performed on the cobas t 711 analyser showed good agreement with the commercially available assays/platforms used as comparator methods, which have previously demonstrated acceptable performance . Each assay produced high correlation coefficients at all sites (fibrinogen, r = 0.990‐0.996; PT‐derived fibrinogen, r = 0.938‐0.943; D‐dimer, r = 0.999‐1.000).…”

“…The fibrinogen, PT-derived fibrinogen, and D-dimer assays performed on the cobas t 711 analyser showed good agreement with the commercially available assays/platforms used as comparator methods, which have previously demonstrated acceptable performance. 33 two systems is in terms of throughput: the high-throughput cobas t 711 can process 390 tests/h, and the medium-throughput cobas t 511 can process 195 tests/h. The cobas t coagulation analysers offer innovative features, including high processing power and increased walkaway time for mid-to high-volume coagulation laboratories.…”

A comparative evaluation of the CN‐6000 haemostasis analyser using coagulation, amidolytic, immuno‐turbidometric and light transmission aggregometry assays

“…It also has a relatively small footprint (CN-6000; 720 × 906 × 1350 cm vs CS-5100; 1030 × 1150 × 1280 cm) and can readily be incorporated into a track system. The purpose of this study was to compare the performance of the CN-6000 haemostasis analyser against the predicate device (CS-5100 system) for assays using clotting, amidolytic, immunoturbidimetric and light transmission aggregometry (VWF ristocetin cofactor assays) methodologies, [3][4][5] using reagents recommended by the manufacturer (Table 1). The protocol was designed using published guidelines.…”