基于智能手机的便携式胱抑素C即时检测透射比浊仪的开发及临床应用  

Development and clinical application of a portable CYS-C instant detection transmission turbidimeter based on smartphones

作　　者：刘志欢 付强强 吴泽 郑磊[1] Liu Zhihuan;Fu Qiangqiang;Wu Ze;Zheng Lei(Southern Medical University,Nanfang Hospital,Guangzhou 510515,China)

机构地区：[1]南方医科大学南方医院检验医学科,广州510515

出　　处：《中华检验医学杂志》2024年第12期1465-1469,共5页Chinese Journal of Laboratory Medicine

基　　金：国家自然科学基金(82202625);中国博士后科学基金(2021M701628)。

摘　　要：目的开发一种基于智能手机的便携、易操作的胱抑素C(CYS-C)透射比浊仪。方法基于智能手机环境光传感器对光信号的敏感性及免疫比浊检测原理, 设计制作一种智能手机比浊仪, 用于血清中CYS-C的即时检测(POCT)。通过3D打印技术制作智能手机比浊仪的主体结构, 并按照设计的电路和光路进行了组装, 同时对装置中光源的稳定性、装置的可行性进行了验证。最后通过与临床使用的全自动生化分析仪的127份血清检测结果进行比较, 评估了智能手机比浊仪的敏感度、特异度和符合率。结果智能手机比浊仪在装置性能测定时, 连续工作60 min光源强度CV=0.9%。同时在CYS-C样本的批次重复测试中CV值均低于5%。检测127份血清中的CYS-C的结果计算敏感度84.4%、特异度95.8%、符合率92.9%, 检测结果与全自动生化分析仪相关系数r=0.902 9。结论开发的智能手机比浊仪在稳定性、一致性和准确性方面表现良好, 与全自动生化分析仪结果高度相关, 证实了其在临床检测CYS-C中的实用性和有效性。Objective:To develop a portable and easy-to-operate Cystatin C(CYS-C)transmission turbidimeter based on smartphones.Methods:?Leveraging the sensitivity of smartphone ambient light sensors to optical signals and the principle of immunoturbidimetry,a smartphone-based turbidimeter was designed and fabricated for point-of-care testing(POCT)of CYS-C in serum.The main structure of the smartphone turbidimeter was created using 3D printing technology and assembled according to the designed circuits and optical paths.At the same time,the stability of the light source and the feasibility of the device were verified.Finally,the sensitivity,specificity,and concordance rate of the smartphone turbidimeter were assessed by comparing its results with those from 127 serum samples of automated biochemical analyzer used in clinic.Results:?During device performance testing,the smartphone turbidimeter exhibited a coefficient of variation(CV)of 0.9%for light intensity over a continuous 60-minute operation.Additionally,the CV values were below 5%in batch repeat tests of CYS-C samples.The detection results of CYS-C in 127 serum samples showed a sensitivity of 84.4%,specificity of 95.8%,and concordance rate of 92.9%,with a correlation coefficient of r=0.9029 compared to the automatic biochemistry analyzer.Conclusion:The developed smartphone turbidimeter demonstrated good stability,consistency,and accuracy,with a high correlation to results from fully automated biochemical analyzers,confirming its practicality and effectiveness in clinical detection of CYS-C.

关 键 词：胱抑素C 即时检验 慢性肾脏疾病 智能手机 免疫透射比浊法 

分 类 号：TH77[机械工程—仪器科学与技术]