全血中人D-二聚体的荧光免疫测定。
Fluorescence immunoassay of human D-dimer in whole blood.
作者信息
Kim Tae Kyum, Oh Sang Wook, Mok Young Joon, Choi Eui Yul
机构信息
Department of Biomedical Science, Hallym University, Chuncheon, South Korea; BodiTech Med, Inc, Chuncheon, South Korea.
出版信息
J Clin Lab Anal. 2014 Jul;28(4):294-300. doi: 10.1002/jcla.21683. Epub 2014 Feb 27.
BACKGROUND
D-dimer is a widely used biomarker for the initial clinical assessment of suspected deep vein thrombosis and pulmonary embolism. Here, we presented a new fluorescence (FL) D-dimer assay system, which was developed with a platform of point-of-care test (POCT) for clinical applications.
METHODS
Whole blood was mixed with FL-labeled anti-D-dimer detector antibody, and then loaded onto a disposable cartridge. After 12 min of incubation, the FL intensity was acquired by scanning of test cartridge and converted as level of D-dimer in a laser FL scanner. The analytical performance of FL immunoassay was evaluated by linearity, recovery, and precision tests. The comparability of the developed assay was examined with automated reference methods.
RESULTS
The FL assay system showed a good linearity, and the analytical mean recovery of control was 103% in a dynamic working range. The imprecision of intra- and inter-as-say of coefficient of variations from assay system was less than 8%. The developed FL assay system showed strong correlation with two automated reference assays, Vidas D-dimer (r = 0.973) and Stalia D-dimer (r = 0.971).
CONCLUSION
The new FL immunoassay for D-dimer is a user-friendly, precise, and reproducible platform of POCT in whole blood.
背景
D - 二聚体是一种广泛用于疑似深静脉血栓形成和肺栓塞初始临床评估的生物标志物。在此，我们展示了一种新的荧光（FL）D - 二聚体检测系统，该系统是基于即时检验（POCT）平台开发用于临床应用的。
方法
将全血与FL标记的抗D - 二聚体检测抗体混合，然后加载到一次性试剂盒中。孵育12分钟后，通过扫描试剂盒获取FL强度，并在激光FL扫描仪中转换为D - 二聚体水平。通过线性、回收率和精密度测试评估FL免疫测定的分析性能。用自动化参考方法检查所开发检测方法的可比性。
结果
FL检测系统显示出良好的线性，在动态工作范围内对照的分析平均回收率为103%。该检测系统批内和批间变异系数的不精密度小于8%。所开发的FL检测系统与两种自动化参考检测方法，即Vidas D - 二聚体（r = 0.973）和Stalia D - 二聚体（r = 0.971）显示出强相关性。
结论
新的用于D - 二聚体的FL免疫测定是一种全血中用户友好、精确且可重复的POCT平台。
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