fda批准的Parsortix®PC1系统的分析性能。

Q3 Medicine
Amy Templeman, M Craig Miller, Martin J Cooke, Daniel J O'Shannessy, Yuwaraj Gurung, Tiago Pereira, Samuel G Peters, Mario De Piano, Manilyn Teo, Negar Khazan, Kyukwang Kim, Evan Cohen, Heather B Lopez, Franklin Alvarez, Mariacristina Ciccioli, Anne-Sophie Pailhes-Jimenez
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引用次数: 0

摘要

简介:Parsortix®PC1系统是美国食品和药物管理局(FDA)批准用于转移性乳腺癌(MBC)患者的一种独立于表位的微流控装置,用于根据细胞大小和可变形性从全血中捕获和收获循环肿瘤细胞。本报告详细介绍了该装置的线性度、检出限、精度和重现性的分析特性。方法:通过采集自自称健康女性志愿者(HVs)和MBC患者的血液样本,并加入预标记培养的乳腺癌细胞系(SKBR3、MCF7或Hs578T),来确定系统性能。样品在Parsortix®PC1系统上处理,捕获的细胞被收集和计数。结果:该系统捕获和收获活的SKBR3、MCF7和Hs578T细胞,并将SKBR3细胞线性固定在2 ~100个细胞之间,平均收获率分别为69%、73%、79%和90%。为了获得≥1个细胞,≥95%的时间,系统分别需要3、5或4个活的SKBR3、MCF7或Hs578T细胞。使用5个、10个和~50个活细胞加入每个细胞系的血液中进行精确研究,平均收获率从63.5%到76.2%不等,重复性和再现性百分比变异系数(%CV)估计分别从12.3%到32.4%和13.3%到34.1%不等。将~20个固定的SKBR3细胞加入到HV和MBC患者血液样本中,平均收获率分别为75.0%±16.1% (%CV = 22.3%)和68.4%±14.3% (%CV = 21.1%)。结论:这些评估表明,Parsortix®PC1系统可以线性地、可重复地从血液中提取1到~100个肿瘤细胞。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Analytical performance of the FDA-cleared Parsortix® PC1 system.

Introduction: The Parsortix® PC1 system, Food and Drug Administration (FDA) cleared for use in metastatic breast cancer (MBC) patients, is an epitope-independent microfluidic device for the capture and harvest of circulating tumor cells from whole blood based on cell size and deformability. This report details the analytical characterization of linearity, detection limit, precision, and reproducibility for this device.

Methods: System performance was determined using K2-EDTA blood samples collected from self-declared healthy female volunteers (HVs) and MBC patients spiked with prelabeled cultured breast cancer cell lines (SKBR3, MCF7, or Hs578T). Samples were processed on Parsortix® PC1 systems and captured cells were harvested and enumerated.

Results: The system captured and harvested live SKBR3, MCF7, and Hs578T cells and fixed SKBR3 cells linearly between 2 and ~100 cells, with average harvest rates of 69%, 73%, 79%, and 90%, respectively. To harvest ≥1 cell ≥95% of the time, the system required 3, 5 or 4 live SKBR3, MCF7 or Hs578T cells, respectively. Average harvest rates from precision studies using 5, 10, and ~50 live cells spiked into blood for each cell line ranged from 63.5% to 76.2%, with repeatability and reproducibility percent coefficient of variation (%CV) estimates ranging from 12.3% to 32.4% and 13.3% to 34.1%, respectively. Average harvest rates using ~20 fixed SKBR3 cells spiked into HV and MBC patient blood samples were 75.0% ± 16.1% (%CV = 22.3%) and 68.4% ± 14.3% (%CV = 21.1%), respectively.

Conclusions: These evaluations demonstrate the Parsortix® PC1 system linearly and reproducibly harvests tumor cells from blood over a range of 1 to ~100 cells.

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来源期刊
Journal of Circulating Biomarkers
Journal of Circulating Biomarkers Medicine-Biochemistry (medical)
CiteScore
3.20
自引率
0.00%
发文量
9
审稿时长
8 weeks
期刊介绍: Journal of Circulating Biomarkers is an international, peer-reviewed, open access scientific journal focusing on all aspects of the rapidly growing field of circulating blood-based biomarkers and diagnostics using circulating protein and lipid markers, circulating tumor cells (CTC), circulating cell-free DNA (cfDNA) and extracellular vesicles, including exosomes, microvesicles, microparticles, ectosomes and apoptotic bodies. The journal publishes high-impact articles that deal with all fields related to circulating biomarkers and diagnostics, ranging from basic science to translational and clinical applications. Papers from a wide variety of disciplines are welcome; interdisciplinary studies are especially suitable for this journal. Included within the scope are a broad array of specialties including (but not limited to) cancer, immunology, neurology, metabolic diseases, cardiovascular medicine, regenerative medicine, nosology, physiology, pathology, technological applications in diagnostics, therapeutics, vaccine, drug delivery, regenerative medicine, drug development and clinical trials. The journal also hosts reviews, perspectives and news on specific topics.
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