CAJ | 학술논문

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。
목적：대국산새과희덕SF-8000응혈측시계통（간칭SF-8000）진행성능평개。방법대SF-8000적정밀도、준학도、선성、가비성등기본성능진행평개。장200 g／L혈홍단백액이1∶200、2∶200、3∶200、4∶200、5∶200비례분별가입도12례신선혈장중，획득실험혈장，여원혈장급염수희석대조혈장응혈결과진행비교；대15례기포표본여대조표본진행배대t검험，비교검측삼수유무차이；대12례신선표본응용신선복용시제급랭장24 h시제분별진행검측，비교측정결과적차이；분별대13례랭장4 h급24 h표본여신선표본진행배대t검험，비교측정결과적차이。결과의기각항기본성능균부합엄가요구。용혈급기포회불동정도영향응혈4항적검측，당혈홍단백농도체도1～1．5 g／L시，활화부분응혈활매시간（APTT）、응혈매원시간（PT）결과여원혈장조산생차이유통계학의의（P＜0．01），체도4 g／L시여대조혈장조차이유통계학의의（P＜0．01）；시제복용24 h후제APTT시제외（P＜0．01），기타항목시제여신복용시제검측결과무명현차이，은정성량호；표본방치4 h불회도치결과출현명현차이，단방치24 h후，APTT、PT、섬유단백원（FIB）결과차이유통계학의의（P＜0．01）。결론 SF-8000응혈측시계통실험성능부합국가、행업표준。응엄격안조사용수책조작，피면간우인소출현，이보증결과적림상괄용성。
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.