Performance evaluation of the fully automated random‐access multiparameter Sysmex CN‐6000 hemostasis analyzer at a core laboratory with a high sample throughput

Abstract

Introduction:We aimed to evaluate the performance of the fully automated multiparameter CN-6000 hemostasis analyzer.Methods: Performance evaluation of the CN-6000 analyzer was conducted for 10 tests including prothrombin time (PT), activated partial prothrombin time (aPTT), fibrinogen level, anti-Xa activity, and antithrombin activity using a unique portfolio of liquid ready-to-use reagents. Precision, sample and reagent carryovers, throughput, and sample turnaround time (STAT) function were prospectively assessed. Results from 343 samples (normal subjects, critically ill patients, patients receiving anticoagulants, subjects with high or low fibrinogen levels, and patients with decreased levels of factor II, V, VII, and X) were compared to those obtained on the STA-R Max 2® analyzer using dedicated reagents.Results: Total precision (coefficient of variation) was below 7% for all parameters in both normal and pathological ranges. For all analyzed parameters, results obtained on the CN-6000 were strongly correlated with those obtained on the STA-R Max 2®analyzer. Agreement between both instruments was excellent for all assays. The CN-6000 demonstrated a 30% higher throughput compared to the STA-R Max 2® (258 vs 185 tests per hour for a panel of tests including PT, aPTT, fibrinogen, factor V, anti-Xa, and D-Dimer). STAT turnaround time for critical care samples testing was <7 minutes. Conclusions:The CN-6000 analyzer performs equivalently or better than the STA-R Max 2® with a significantly improved throughput. This new hemostasis multiparameter analyzer appears to be particularly well suited for coagulation laboratories which require high sample throughput and manage high numbers of nonstandard and critical care samples.

Performance evaluation of the Sysmex CN-6000-automated coagulation analyzers for routine coagulation tests

“…In this study, all items show R 2 values of 0.93 or higher, so the two test methods show a high correlation. In other similar studies, STA-R and CN6000 were compared, confirming a high correlation between the coagulation test results between equipment and reagents in PT, APTT, FBG, anti-Xa activity and AT [17]. For the FBG test, the measurement ranges of the two test methods are different, which shows a large intercept value in the correlation analysis.…”