Orhan Seren, İşbilen Elif
Gaziantep University, Faculty of Medicine, Department of Medical Biochemistry, Gaziantep, Turkey.
J Med Biochem. 2025 Aug 21;44(5):976-984. doi: 10.5937/jomb0-56377.
Routine coagulation testing is critical in diagnosing hemostatic disorders and monitoring anticoagulant therapy. The SYSMEX CN-6000 and STAGO STA-R analyzers utilise different clot detection methods, which may impact test results. This study evaluates the analytical performance of these two automated coagulation analysers and examines the effects of hemolysis and lipemia on routine coagulation tests.
Blood samples were collected from patients at Gaziantep University Şahinbey Research and Application Hospital and analysed for activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (FBG), and D-dimer using both analysers. Precision, method comparison, and interference studies were conducted following CLSI guidelines. Hemolysis and lipemia were induced in vitro, and their effects on test results were evaluated based on Fraser's criteria.
All precision study CV values were within the acceptable limits of biological variation. APTT results exhibited a significant systematic difference between analysers (r= 0.872), whereas PT (INR), FBG, and D-dimer showed strong correlations (r> 0.945). Hemolysis had a minimal impact at lower concentrations (<1 g/L). However, at 4 g/L, PT bias increased to 2.8% for the CN-6000 and 2.0% for the STA-R, with similar increases observed in APTT and FBG. Lipemia significantly affected CN-6000, which failed to produce PT results at triglyceride levels 14 mmol/L and APTT/FBG results at 28 mmol/L. In contrast, STA-R provided results with biases below 7.3% at all lipemia levels.
Both analysers demonstrated strong analytical performance, though methodological differences influenced APTT measurements. Hemolysis had a minor impact within Fraser's acceptable bias limits, whereas CN-6000 exhibited performance limitations in severely lipemic samples, necessitating preanalytical lipid-reducing strategies. These findings underscore the need for expanded reference range studies and optimised laboratory workflows to enhance coagulation testing reliability.
常规凝血检测对于诊断止血障碍和监测抗凝治疗至关重要。希森美康CN - 6000和思塔高STA - R分析仪采用不同的凝血检测方法，这可能会影响检测结果。本研究评估了这两种自动凝血分析仪的分析性能，并研究了溶血和脂血对常规凝血检测的影响。
从加济安泰普大学萨欣贝伊研究与应用医院的患者中采集血样，使用两种分析仪对活化部分凝血活酶时间（APTT）、凝血酶原时间（PT）、纤维蛋白原（FBG）和D - 二聚体进行分析。按照临床和实验室标准协会（CLSI）指南进行精密度、方法比较和干扰研究。在体外诱导溶血和脂血，并根据弗雷泽标准评估它们对检测结果的影响。
所有精密度研究的变异系数（CV）值均在生物学变异的可接受范围内。APTT结果在分析仪之间表现出显著的系统差异（r = 0.872），而PT（国际标准化比值，INR）、FBG和D - 二聚体显示出强相关性（r > 0.945）。溶血在较低浓度（<1 g/L）时影响最小。然而，在4 g/L时，CN - 6000的PT偏差增加到2.8%，STA - R的PT偏差增加到2.0%，APTT和FBG也有类似增加。脂血对CN - 6000有显著影响，在甘油三酯水平为14 mmol/L时无法得出PT结果，在28 mmol/L时无法得出APTT/FBG结果。相比之下，STA - R在所有脂血水平下提供的结果偏差均低于7.3%。
两种分析仪均表现出强大的分析性能，尽管方法学差异影响了APTT测量。溶血在弗雷泽可接受偏差范围内影响较小，而CN - 6000在严重脂血样本中表现出性能局限性，因此需要采用分析前降低血脂的策略。这些发现强调了开展扩大参考范围研究和优化实验室工作流程以提高凝血检测可靠性的必要性。
