Latex Test BL-2P-FDP试剂盒在Sysmex CA7000及CS5100全自动凝血仪上的性能验证  

Performance verification of Latex Test BL-2 P-FDP Kit on sysmex automatic coagulation analyzers CA7000 and CS5100

作　　者：毛镭篥 寿玮龄 陈倩[1] 谢田 崔巍 吴卫 

机构地区：[1]中国医学科学院北京协和医院北京协和医院检验科,北京100730

出　　处：《中国卫生检验杂志》2016年第10期1401-1405,共5页Chinese Journal of Health Laboratory Technology

摘　　要：目的评估Latex Test BL-2 P-FDP纤维蛋白(原)降解产物试剂盒分别在Sysmex CA7000和CS5100全自动凝血仪上的性能。方法根据美国临床实验室标准化研究所(CLSI)系列文件和其他相关文献的实验方案,对两套系统的不精密度、准确度、线性范围、携带污染率、参考范围、检测下限和抗干扰试验、方法学比对等性能进行验证分析。结果不精密度与准确度均在允许范围内,表明验证通过。线性验证实测均值与预测值偏离均<15%,符合要求。CA7000和CS5100 2台仪器检测FDP的携带污染率均为0%,符合要求。CA7000和CS5100分析FDP的检测下限结果分别为(2.63±0.28)μg/ml、(2.64±0.07)μg/ml,均在2μg/ml^3μg/ml,符合要求。对Latex Test BL-2 P-FDP试剂盒在CA7000和CS5100 2套检测系统的检测结果进行相关回归分析,y=0.881x+1.811,r=0.987(P>0.05),2个检测系统间结果一致性较好。结论 Latex Test BL-2 P-FDP试剂盒应用在Sysmex CA7000和CS5100全自动凝血仪测定时的主要性能指标,已达到临床检测需求。Objective To evaluate the analytical performance of Latex Test BL- 2 P- FDP fibrinogen degradation product＇s（ FDP） Kit on Sysmex automatic coagulation analyzers CA7000 and CS5100. Methods According to a series of files of American Clinical Laboratory Standardization Institute（ CLSI） and other relevant experimental documents,to verify and analyze the performance of FDP＇s non- precision,accuracy,linear range,carryover rate,reference range,detect limit,interference test and method comparison. Results The non- precision and accuracy were both in the allowable ranges,with the validations passed. The bias of measured average values and predicted values were both less than 15%,which met the requirements. The carryover rate of FDP detection by using CA7000 and CS5100 were both 0%,which reached requirements. The detection limits of CA7000 and CS5100 were（ 2. 63 ± 0. 28） μg / ml,（ 2. 64 ± 0. 07） μg / ml respectively,which met the range of 2 μg / ml- 3μg /ml,meeting the requirement. The detection results measured by Latex Test BL- 2 P- FDP kits on CA7000 and CS5100 were conducted for correlation and regression analysis,y = 0. 881 x ＋ 1. 811,r = 0. 987（ P〉0. 05）. The results of the two detection systems were in good agreements. Conclusion The main performance index of Latex Test BL- 2 P- FDP kits used in CA7000 and CS5100 Sysmex automatic coagulation analyzer have reached the clinical detection requirements.

关 键 词：CA7000 CS5100 LATEX TEST BL-2 P-FDP试剂盒 性能验证 

分 类 号：O652.3[理学—分析化学]