基于微流控技术的细胞分析仪研制及其应用
基于微流控技术的细胞分析仪研制及其应用
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深圳市科技计划项目(CKCY2017050310133507)

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Development and Application of Cell Analyzer Based on Microfluidic Technology
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Shenzhen Science and Technology Project(CKCY2017050310133507)

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    摘要:

    该研究将库尔特原理与微流控技术结合,开发了一款基于微流控技术的细胞分析仪和配套 芯片,实现了快速准确的白细胞计数。该微流控芯片由多层结构组成,液体在芯片上下层间流动,完 全与设备隔离,可即用即抛。采用该仪器和芯片对标准粒子和白细胞分别进行测试的结果显示,该分 析仪和芯片对不同直径标准粒子重复计数结果的变异系数分别为 4.95%、3.56% 和 2.13%;与希森美 康血细胞分析仪 XN20 对白细胞总数计数结果的比较可知,两者(XN20 和 CS1700)的线性回归系数 R2=0.999 7;Bland-Altman 作图得出 95% 以上的点都在“95% 一致性界限”内波动;在 3.00×109/L、 11.00×109/L 和 30.00×109/L 三个医学决定水平处的预期偏倚百分比分别为 2.12%、0.54% 和 0.17%。 这表明,该细胞分析仪对标准粒子测试重复性良好,对白细胞测试结果与希森美康 XN20 的测试结果 具有可比性,可用于临床血样的白细胞检测,尤其适应于农村卫生室等基层医疗单位使用。

    Abstract:

    A novel cell analyzer and a component biochip, based on microfluidic technology and Coulter principle, was developed to count leukocyte cells for point-of-care testing. The microfluidic chip was composed of multi-layer structure, and the liquid flowed between the upper and lower layers of the chip, not in contact with the cell analyzer. The cell analyzer and chips were used to test standard particles and leukocyte cells to characterize the performance. The results showed that the variation coefficients of the standard particle counting results are 4.95%, 3.56% and 2.13% with different diameters, respectively. The total leukocyte count results by the microfluidic cell analyzer and hematology analyzer Sysmex XN20 were compared. The linear regression coefficient R2 is 0.999 7. Bland-Altman plots showed that more than 95% of points fluctuate within the 95% consistency bound. The expected bias percentages at the three medical decision levels of 3.00×109/L, 11.00×109/L and 30.00×109/L were 2.12%, 0.54%, and 0.17%, respectively. Thus, the cell analyzer has good repeatability for standard particle test, and the results of leukocyte test are comparable with those of XN20. It can be used to detect leukocyte in clinical blood sample, especially suitable for village clinics and other basic medical units.

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引文格式
吴志成,陈卫布,宋美嘉,王小英,游 璠,吴志红.基于微流控技术的细胞分析仪研制及其应用 [J].集成技术,2020,9(6):13-20

Citing format
WU Zhicheng, CHEN Weibu, SONG Meijia, WANG Xiaoying, YOU Fan, WU Zhihong. Development and Application of Cell Analyzer Based on Microfluidic Technology[J]. Journal of Integration Technology,2020,9(6):13-20

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  • 在线发布日期: 2020-11-24
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