摘要
目的:验证BC-7500CS全自动血细胞分析仪全血C反应蛋白检测系统(以下简称“BC-7500CS全血CRP检测系统”)的性能。方法:参考行业相关标准,从空白测定、携带污染率、精密度、线性范围、不同检测系统可比性、正确度、干扰试验(甘油三酯、胆红素)、血细胞压积自动校正公式、生物参考区间9个方面验证BC-7500CS全血CRP检测系统检测全血C反应蛋白(C-reactive protein,CRP)的性能。结果:BC-7500CS全血CRP检测系统的空白测定结果≤0.2 mg/L,携带污染率为0.01%。该系统检测正常浓度和病理浓度样本的批内标准差分别为0.05、0.78 mg/L,批间标准差分别为0.38、1.99 mg/L;检测正常浓度和病理浓度样本批内变异系数为1.05%和1.61%,批间变异系数为6.83%和3.95%。该系统检测CRP的线性范围为0~274.03 mg/L。该系统与BNII特定蛋白分析仪的CRP检测结果相关性良好,r≥0.975。该系统检测参考物的偏倚均在±10%范围内。干扰试验显示,甘油三酯浓度≤427.2 mmol/L时与未加入甘油三酯的样本CRP相对偏差均在±10%范围内、胆红素浓度≤433μmol/L时与未加入胆红素的样本CRP相对偏差均在±10%范围内。血细胞压积自动校正公式验证结果显示线性关系良好。生物参考区间验证结果显示,样品的CRP值完全在现有生物参考区间,符合要求。结论:BC-7500CS全血CRP检测系统的各项性能均达到厂家及相关标准要求,可满足临床使用需求。
Objective To validate the performance of the whole blood C-reactive protein(CRP)detection system of BC-7500CS automated hematology analyzer.Methods The whole blood CRP detection system of BC-7500CS automated hematology ana-lyzer was verified based on relevant industrial standards in terms of blank determination,carry-over contamination rate,precision,linear range,comparability of different detection systems,correctness,interference test(triglyceride,bilirubin),auto-correction formula of hematocrit and biological reference interval.Results The whole blood CRP detection system had the blank determination results less than 0.2 mg/L and the carry-over contamination rate being 0.01%.The within-run standard deviations(SDs)of the system for the samples with normal and pathological concentrations were 0.05 and 0.78 mg/L respecti-vely,and the between-run SDs were 0.38 and 1.99 mg/L respectively;the within-run coefficients of variation of the system for the samples with normal and pathological concentrations were 1.05%and 1.61%respectively,and the between-run SDs were 6.83%and 3.95%respectively.The linear range of the system for CRP detection was restricted within 0 and 274.03 mg/L.The system correlated well with BNII speical protein analyzer for CRP detection with r≥0.975.The biases of the system for detecting the reference material were all within±10%.Interference tests showed that the relative deviations of CRP were all within±10%between the samples with or without triglyceride(concentration≤427.2 mmol/L)and between the samples with or without bilirubin(concentration≤433μmol/L).The auto-correction formula of hematocrit proved the system behaved well in linearity.The results of the biological reference interval validation indicated that the CRP values of the samples were well within the existing biological reference intervals and met the requirements.Conclusion The whole blood CRP detection system of BC-7500CS automated hematology analyzer has its performance indexes meet the requirements of the manufacturer and relevant standards,and can be applied clinically.
作者
林淳峥
甘志忠
梁声强
LIN Chun-zheng;GAN Zhi-zhong;LIANG Sheng-qiang(Department of Clinical Laboratory,the 909th Hospital,Dongnan Hospital of Xiamen University,Zhangzhou 363000,Fujian Province,China)
出处
《医疗卫生装备》
CAS
2024年第12期55-60,共6页
Chinese Medical Equipment Journal
