循环肿瘤细胞检测系统性能验证研究

Research for detecting the capability of CTCBiopsy®-A10

目的:针对前期研发出的循环肿瘤细胞(CTC)检测设备CTCBiopsy®-D100存在的“堵管”(凝血)现象,采用真空负压及半自动的过滤方式对样本进行处理,研发出了CTCBiopsy®-A10,通过试验验证其检测性能。方法:通过对仪器的堵管率、CTC的检出率、仪器运行过程中对细胞形变的影响,以及是否自发产生循环肿瘤微栓(CTM)四个方面比较了CTCBiopsy®-A10和CTCBiopsy®-D100的性能优劣。结果:与CTCBiopsy®-D100相比,CTCBiopsy®-A10的堵管率更低,CTC和CTM检出率更高,存在显著性差异;两种检测设备对细胞形变的影响无显著性差异,二者均可检出样本中的CTM,且在仪器运行过程中不自发产生CTM。结论:D100和A10对CTC和CTM均表现出了较好的检出率和较低的堵管率,A10在性能方面有进一步的优化和提升,降低了堵管率,提高了CTC的检测效率。

Objective:In order to solve the“clogging”problem of existing circulating tumor cell(CTC)detection equipment CTCBiopsy®-D100,CTCBiopsy®-A10 was developed useing vacuum negative pressure and semi-automatic filtration to process samples,experiments were verified to detect its performance.Method:The CTCBiopsy®-A10 and CTCBiopsy®-D100 were compared in four aspects:the tube blocking rate of the instrument,the detection rate of CTC,the effect on cell deformation during the operation of the instrument,and whether the circulating tumor microthrombi(CTM)was spontaneously generated.Results:Compared with CTCBiopsy®-D100,CTCBiopsy®-A10 had lower tube blocking rate,higher detection rate of CTC and CTM,and there were significant differences;there was no significant difference in the effects of the two detection devices on cell deformation.Both can detect CTM in the sample,and CTM is not generated spontaneously during the operation of the instrument.Conclusion:D100 and A10 showed better detection rate and lower blocking rate for CTC and CTM.A10 has been further optimized and improved in performance,reducing the blocking rate and improving the detection efficiency of CTC.