Haemostasis Research Unit, University College London, London, UK.
Haematology Evaluations Unit, HSL (Analytics) LLP, London, UK.
Int J Lab Hematol. 2020 Oct;42(5):643-649. doi: 10.1111/ijlh.13271. Epub 2020 Jun 17.
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.
To evaluate the performance of the CN-6000 against a predicate device.
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).
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).
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.
CN-6000（希森美康公司）是一种新型的止血分析仪，具有凝血、酰胺分解、免疫比浊和光传输聚集（LTA）功能。透射光在多个波长（340、405、575、660、800nm）下从 LED 光源进行监测。
评估 CN-6000 与预测设备的性能。
使用来自正常受试者、抗凝患者、危重症患者、高纤维蛋白原或低纤维蛋白原含量或异常干扰物质水平的 880 个样本，对 CN-6000 与 CS-5100（希森美康）进行了 14 项不同的测试。使用商业 QC 材料（每天 5 天，每个样本重复 10 次）评估批内检测不精密度。
所有检测均获得可接受的精密度水平。两台分析仪之间的所有检测结果均具有良好的一致性。使用 CN-6000 的检测速度提高了 35%（PT、aPTT 和纤维蛋白原的检测速度分别为 337 次/小时和 250 次/小时）。CN-6000 还通过减少由于低透光率而导致的“表决剔除”（由于低透光率而导致的表决剔除），显示出在高干扰物质水平的血浆中改善了血凝块检测，减少了 29%（24 比 34）。
CN-6000 与预测仪器具有极好的可比性，所有检测均具有可接受的精密度水平。还显示了在存在干扰物质时吞吐量和血凝块检测的改善。
