摘要
目的:评估溴甲酚紫标识结合垫对常规C反应蛋白(C-Reactive Protein,CRP)荧光量子点免疫层析试剂盒性能的影响,探讨溴甲酚紫作为结合垫标识染料的潜在应用价值。方法:通过最低检出限、精密度、准确度、荧光信号强度变化、稳定性以及临床实验评估等指标,对溴甲酚紫标识结合垫的CRP荧光量子点免疫层析试剂盒性能进行评价。结果:溴甲酚紫标识结合垫的试剂盒最低检出限为4.64 mg/L(<5 mg/L),变异系数≤15%(精密度),相对偏差≤15%(准确度)。溴甲酚紫添加量在5%的体积分数范围内,检测信号随溴甲酚紫浓度增加逐渐减弱,T/C则呈上升趋势。稳定性分析显示,试剂卡在4℃和37℃储存条件下均具有较好的信号稳定性。对109份临床样本进行检测,线性回归分析显示相关系数R^(2)=0.9887;Bland-Altman分析表明,94.50%的样本落在一致性界限范围内,与对照试剂盒检测结果一致性良好。结论:溴甲酚紫对CRP荧光量子点免疫层析试剂盒的性能指标无明显不利影响,检测结果与常规试剂盒一致,可作为结合垫标识染料应用。
Objective:To evaluate the impact of bromocresol purple(BCP)-labeled conjugate pads on the performance of conventional C-reactive protein(CRP)quantum dot fluorescence immunochromatographic assay kits and to explore the potential application of BCP as a labeling dye for conjugate pads.Methods:The performance of the CRP quantum dot fluorescence immunochromatographic assay kit using BCP-labeled conjugate pads is assessed based on key metrics,inlcuding the limit of detection(LOD),accuracy,precision,changes in fluorescence signal intensity,stability,and clinical validation experiments.Results:The assay kit with BCP-labeled conjugate pads exhibite an LOD of 4.64 mg/L(lower than 5 mg/L),with a coefficient of variation lower than 15%(precision)and a relative deviation lower than 15%(accuracy).Within a 5%volume concentration range of BCP,signals show a progressive decrease with increasing BCP concentration,while the T/C value shows an upward trend.Stability analysis demonstrate that the assay cards maintain good signal stability under both 4℃and 37℃storage conditions.Analysis of 109 clinical samples yield a correlation coefficient(R^(2))of 0.9887,and Bland-Altman analysis reveale that 94.50%of the samples fall within the consistency limits,demonstrating good agreement with the control kit results.Conclusion:BCP has no significantly affect the performance metrics of the CRP quantum dot fluorescence immunochromatographic assay kit,and its detection results are consistent with those of conventional kits.These findings suggest that BCP holds potential as an effective labeling dye for conjugate pads in immunochromatographic assay.
作者
黄巧娘
曾世涌
张机智
陈文标
HUANG Qiaoniang;ZENG Shiyong;ZHANG Jizhi;CHEN Wenbiao(Department of Basic Medicine,Quanzhou Medical College,Quanzhou 362011,China;Affiliated People’s Hospital of Quanzhou Medical College,Quanzhou 362011,China)
出处
《生物化工》
2025年第4期24-29,共6页
Biological Chemical Engineering
基金
泉州市科技局2021年度医疗卫生领域指导性科技计划项目(2021N128S)。
关键词
溴甲酚紫
量子点
免疫层析
C反应蛋白(CRP)
bromocresol purple
quantum dots
immunochromatography
C-reactive protein(CRP)
