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

Abstract

Background The CN‐6000 (Sysmex Corp.) is a new haemostasis analyser with blood coagulation, amidolytic, immuno‐turbidometric and light transmission aggregometry (LTA) capabilities. Transmitted light is monitored at multiple wavelengths (340, 405, 575, 660, 800 nm), from an LED light source. Aims To evaluate the performance of the CN‐6000 against a predicate device. Methods The CN‐6000 was evaluated against the CS‐5100 (Sysmex) for 14 different tests, using 880 samples from normal subjects, anticoagulated patients, critically ill patients, plasmas with high or low fibrinogen content or abnormal levels of interfering substances. Between‐day assay imprecision was assessed using commercial QC materials (n = 10 replicates on each of 5 days). Results Acceptable levels of imprecision were obtained for all assays. Agreement between the two analysers was excellent for all assays. Throughput was 35% higher using the CN‐6000 (337 vs 250 tests per hour for PT, aPTT and fibrinogen). The CN‐6000 also demonstrated improved clot detection in plasmas with high levels of interfering substances as demonstrated by a 29% reduction in “vote‐outs” due to low light transmission (24 vs 34). Conclusions The CN‐6000 demonstrated excellent comparability with the predicate instrument and acceptable levels of imprecision in all assays. Improvements in throughput and clot detection in the presence of interfering substances were also shown.

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

“…Our results are in line with those of Gardiner et al who performed an external validation of the CN-6000 against the CS-5100 analyzer. 14 Agreement between the two instruments was found to be excellent for 14 assays. In addition, the CN-6000 showed improved specificity to HIL compared to the CS-5100.…”

Pre‐analytical variables in haemostasis: Findings from the United Kingdom National External Quality Assessment scheme for Blood Coagulation (UK NEQAS BC) haemolysis exercise

“…Such interference increases the optical absorbance and can affect analyte concentration via intervention in spectrophotometric laboratory assays therefore making final results unreliable. Some analysers have multiple wavelength options for monitoring clot formation optically, with the possibility to switch wavelength for clot detection in the presence of interfering substances like haemoglobin so that a wavelength away from the absorbance peak is used to reduce the impact of any optical interference 25 . A number of centres did not utilize automated assessment despite the availability locally of analysers with that capability.…”

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

“…The CN-6000 uses an optical clot detection method to detect the change in turbidity of the sample reaction mixture during the coagulation process. However, unlike the mechanical coagulation time method, the optical clot detection technique is unable to generate a result for strong lipemic or icteric samples [1,2].…”

“…The Sysmex CN-6000 (Sysmex, Kobe, Japan), a novel, fully automated, and high-throughput coagulation analyzer, is capable of performing clotting, chromogenic and immunological assays and aggregation testing [1,2]. It features a relatively small footprint (0.72 Â 0.91 Â 1.35 m) and can be easily used in a tracking system.…”