赛科希德SF-8000凝血测试系统性能评价

Performance evaluation of SUCCEEDER SF-8000 coagulation testing system

目的：对国产赛科希德SF-8000凝血测试系统（简称SF-8000）进行性能评价。方法对SF-8000的精密度、准确度、线性、可比性等基本性能进行评价。将200 g／L血红蛋白液以1∶200、2∶200、3∶200、4∶200、5∶200比例分别加入到12例新鲜血浆中，获得实验血浆，与原血浆及盐水稀释对照血浆凝血结果进行比较；对15例气泡标本与对照标本进行配对t检验，比较检测参数有无差异；对12例新鲜标本应用新鲜复溶试剂及冷藏24 h试剂分别进行检测，比较测定结果的差异；分别对13例冷藏4 h及24 h标本与新鲜标本进行配对t检验，比较测定结果的差异。结果仪器各项基本性能均符合厂家要求。溶血及气泡会不同程度影响凝血4项的检测，当血红蛋白浓度达到1～1．5 g／L时，活化部分凝血活酶时间（APTT）、凝血酶原时间（PT）结果与原血浆组产生差异有统计学意义（P＜0．01），达到4 g／L时与对照血浆组差异有统计学意义（P＜0．01）；试剂复溶24 h后除APTT试剂外（P＜0．01），其它项目试剂与新复溶试剂检测结果无明显差异，稳定性良好；标本放置4 h不会导致结果出现明显差异，但放置24 h后，APTT、PT、纤维蛋白原（FIB）结果差异有统计学意义（P＜0．01）。结论 SF-8000凝血测试系统实验性能符合国家、行业标准。应严格按照使用手册操作，避免干扰因素出现，以保证结果的临床适用性。

Objective To evaluate the performance of domestic SUCCEEDER SF-8000 coagulation testing system （SF-8000）.Methods The precision, accuracy, linearity, comparability and so on of SF-8000 were evaluated.The 200 g/L hemoglobin solution was added to 12 cases of fresh plasma in the proportions of 1∶200, 2∶200, 3∶200, 4∶200 and 5∶200, and the experimental plasma was prepared.The differences of the results in the experimental plasma, the original plasma and the brine-diluted control plasma were analyzed.The differences of 15 cases of bubble specimens and control specimens′results were analyzed by paired t-test.The 12 fresh specimens were measured with fresh dissolved-reagents and 24h-refrigerated reagents separately, and the differences of the 2 sets of results were analyzed.A total of 13 cases of 4h-refrigerated specimens, 24h-refrigerated specimens and fresh specimens were measured, and the differences were analyzed.Results The basic properties of the instrument were all in accordance with the requirements of manufacturers. Hemolysis and bubbles affected the results of SF-8000 in different levels. When hemoglobin concentration reached 1-1.5 g/L, the results of activated partial thromboplastin time（APTT）and prothrombin time（PT） had significantly statistical differences from those of the original plasma group（P〈0.01）, when it reached 4 g/L, they had statistically significant differences from the control plasma group（P〈0.01）.In addition to the reagent of APTT （P〈0.01）, the results of 24 h-refrigerated reagents and fresh refrigerated reagents had no statistical differences with good stability.The results of 4h-refrigerated specimens and fresh specimens had no statistical difference, but the results of 24 h-refrigerated specimens and fresh specimens in APTT, PT and fibrinogen（ FIB） had statistical significance（ P〈0.01）.Conclusions The performance of SF-8000 meets the national and industrial standards.The manual operation should be strictly carried out to avoid appearing confounding factors, in order to ensure the results with clinical applicability.