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

• Published in: International journal of laboratory hematology Vol. 42; no. 5; pp. 643 - 649
• Main Authors: Gardiner, Chris, Lane, Philip, Langley, Katy, Tailor, Hitesh, Machin, Samuel J., Mackie, Ian J.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-10-2020; John Wiley and Sons Inc
• Subjects: Blood Coagulation; Blood Coagulation Tests - instrumentation; Blood Coagulation Tests - methods; Blood Coagulation Tests - standards; coagulation; Fibrinogen; Humans; laboratory automation; laboratory practice; Original; ORIGINAL ARTICLES; Reproducibility of Results; Sensitivity and Specificity; coagulation; laboratory automation; laboratory practice
• ISSN: 1751-5521; 1751-553X
• DOI: 10.1111/ijlh.13271

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.