摘要
目的:凝血指标检测被广泛应用于临床诊断和治疗。通过对全自动血凝分析仪Sysmex CS-5100与CNB ZK-6000的三种方法学比对分析,评价两款仪器是否具有可比性,检测结果是否具有一致性,进而对CNB ZK-6000进行性能评价。方法:收集检测当天新鲜枸橼酸钠抗凝血浆样本,以Sysmex CS-5100为参考仪器,CNB ZK-6000为比对仪器,利用三种方法学的检测模块,即免疫比浊法测定D-二聚体(DD)浓度、发色底物法测定抗凝血酶III(AT-III)活性、凝固法测定凝血因子V(FV)活性,对三种方法学检测结果进行比对分析。结果:两款全自动血凝分析仪分别检测60例、63例和65例新鲜枸橼酸钠抗凝血浆样本的DD浓度、AT-III活性及FV活性,其结果在统计学上无差异(P>0.05,r>0.9),偏差均小于等于CLIA'88允许误差的1/2或国家卫健委临检中心室间质评可接受范围的1/2(FV≤±12.5%,AT-III≤±10%,D-二聚体≤±25%),95%的点位于一致性界限(LoA)范围内,符合临床可接受标准。结论:CNB ZK-6000与Sysmex CS-5100的检测结果具有良好的一致性,可为实验室多仪器联用提供依据。
Objective:Coagulation indicator detection is widely used in clinical diagnosis and treatment.This study aims to evaluate the comparability of instruments from two manufacturers and the consistency of detection results,and then evaluate the performance of CNB ZK-6000 by analyzing the three methodologies of the fully automated blood coagulation analyzers Sysmex CS-5100 and CNB ZK-6000.Methods:Fresh plasma samples anticoagulated with sodium citrate were collected on the day of testing.The Sysmex CS-5100 was designated as the reference instrument,while the CNB ZK-6000 served as the comparative instrument.Three distinct methodological modules were applied for analysis:the immunoturbidimetric method was used to determine D-Dimer(DD)concentration,the chromogenic substrate method was employed to assess antithrombin III(AT-III)activity,and the clotting method was utilized to measure coagulation factor V(FV)activity.The results obtained from these three methodologies were subsequently subjected to comparative analysis.Results:A total of 60 samples for DD concentration,63 for AT-III activity,and 65 for FV activity were analyzed using two types of blood coagulation analyzers respectively.The results indicated no statistical difference(P>0.05,r>0.9)and the observed deviations were less than or equal to half of the CLIA'88 allowable error or the acceptable range for the inter-laboratory quality assessment conducted by the Clinical Laboratory Center of the National Health Commission(FV≤±12.5%,AT-III≤±10%,D-Dimer≤±25%).Ninety-five percent of the points were within the consistency limit(LoA)range,which meets the clinically acceptable standards.Conclusion:The test results from CNB ZK-6000 and Sysmex CS-5100 have good consistency,which can provide a basis for the combination of multiple instruments in the laboratory.
作者
赵珂欣
刘静
陆露
柳忠玉
余知和
ZHAO Ke-xin;LIU Jing;LU Lu;LIU Zhong-yu;YU Zhi-he(College of Life Sciences,Yangtze University,Jingzhou,Hubei 434023,China;Beijing CNB Biotech Co.,LTD,Beijing 100176,China)
出处
《现代生物医学进展》
2026年第6期801-808,共8页
Progress in Modern Biomedicine
