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Clinical Evaluation of the Pre-Analytical Capabilities of Hemostasis Instrument
Clinical and Applied Thrombosis/Hemostasis ( IF 2.9 ) Pub Date : 2022-08-04 , DOI: 10.1177/10760296221118483
Mingyu Yang 1 , Xiaoning Gui 1 , Run Wang 1 , Shiju Jiang 1 , Jing Zhou 1 , Jian Chen 1 , Meiling Wang 1 , Jiwei Ning 1 , Linzi Miao 1 , Hongwei Liu 2 , Xiaomei Tang 2 , Chenxue Qu 1
Affiliation  

Objective: Evaluate the technical performance of the pre-analytical hemolysis-icterus-lipemia (HIL) check module on the ACL-TOP-750. Methods: 8433 routine coagulation samples were evaluated for HIL, the presence of clotting and low sample volume by both visual inspection and the pre-analytical HIL check module on the ACL-TOP-750. Results: 7726 samples were in agreement with both methods and 707 were not consistent. 356 samples with low volume were identified by visual inspection and 920 by the instrument (2.7 mL threshold). Visual inspection identified 56 lipemic samples while 13 of those with moderate or high lipemia were identified by the instrument. Visual inspection identified 47 hemolyzed samples while 7 with moderate or high hemolysis were identified by the instrument. Both visual inspection and the instrument identified 36 icteric samples. For triglyceride concentration and bilirubin concentration, there was good correlation between the ACL-TOP-750 and the DXC800 biochemistry analyzer. Among 30 samples with varying amounts of clotting, 27 were discovered by visual inspection and 3 were discovered by the instrument. Conclusion: The pre-analytical check module on the ACL-TOP-750 improved the detection rate of samples below the target 2.7 mL volume, and the accuracy in detection of HIL. However, the automated method could not replace visual assessment of clotting in samples.



中文翻译:

止血仪预分析能力的临床评价

目的:评估 ACL-TOP-750 上分析前溶血-黄疸-脂血症 (HIL) 检查模块的技术性能。方法:通过目视检查和 ACL-TOP-750 上的分析前 HIL 检查模块评估 8433 个常规凝血样本的 HIL、凝血存在和样本量低。结果:7726 个样品与这两种方法一致,707 个样品不一致。356 个小体积样品通过目测鉴定,920 个通过仪器鉴定(阈值 2.7 mL)。目测识别出 56 个脂血样本,而仪器识别出 13 个中度或高脂血症样本。目测识别出 47 个溶血样品,而仪器识别出 7 个中度或高度溶血样品。目视检查和仪器均识别出 36 个黄疸样本。对于甘油三酯浓度和胆红素浓度,ACL-TOP-750与DXC800生化分析仪具有良好的相关性。30份凝血量不等的样本中,27份通过目测发现,3份通过仪器发现。结论:ACL-TOP-750 上的分析前检查模块提高了低于目标 2.7 mL 体积的样品的检测率,以及检测 HIL 的准确性。然而,自动化方法不能取代对样品中凝血的视觉评估。

更新日期:2022-08-08
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