CellMax平台通过枚举罕见循环肿瘤细胞进行癌症早期检测的分析验证。

Q3 Medicine
Journal of Circulating Biomarkers Pub Date : 2019-12-31 eCollection Date: 2019-01-01 DOI:10.1177/1849454419899214
Pratyush Gupta, Zulfiqar Gulzar, Ben Hsieh, Austin Lim, Drew Watson, Rui Mei
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引用次数: 14

摘要

CellMax (CMx®)平台的开发是为了在全血中富集上皮循环肿瘤细胞(CTCs)。本报告提供了检测性能数据,包括在细胞培养基或健康供体血液样本中加标的癌细胞系细胞(clc)的准确性、线性度、空白限、检测限(LOD)、特异性和计数精度。此外,在32名年轻健康供体中证明了检测的特异性,并在47名受试者中证明了临床可行性,这些受试者包括健康供体和结肠镜检查证实患有结直肠癌、腺瘤或阴性结果的患者。CMx平台对所有CLC检测浓度的计数具有较高的准确性、线性度和灵敏度,包括2 mL血液中1至10个细胞的极低范围,这与早期癌症检测最为相关。理论上,测定LOD为0.71 ctc / 2ml血液。32例年轻健康供体样本的分析特异性为100%。我们还证明了在多天和多个操作人员之间的精度,并具有良好的重复性采收率。在一项临床可行性研究中,CMx平台识别出10名患病受试者中有8名为阳性(80%临床敏感性),5名对照中有4名为阴性(80%临床特异性)。我们还比较了来自两个不同地点的类似血液样本的处理时间和运输效果,并评估了基于人工智能的计数方法。最后,与其他平台捕获的ctc保留在铁磁珠上或系在载片表面不同,CMx平台独特的空气泡沫释放ctc允许捕获的细胞从微流控芯片转移到Eppendorf管,从而实现无缝过渡到下游应用,如遗传分析和活细胞操作。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Analytical validation of the CellMax platform for early detection of cancer by enumeration of rare circulating tumor cells.

Analytical validation of the CellMax platform for early detection of cancer by enumeration of rare circulating tumor cells.

Analytical validation of the CellMax platform for early detection of cancer by enumeration of rare circulating tumor cells.

Analytical validation of the CellMax platform for early detection of cancer by enumeration of rare circulating tumor cells.

The CellMax (CMx®) platform was developed to enrich for epithelial circulating tumor cells (CTCs) in the whole blood. This report provides assay performance data, including accuracy, linearity, limit of blank, limit of detection (LOD), specificity, and precision of enumeration of cancer cell line cells (CLCs) spiked in cell culture medium or healthy donor blood samples. Additionally, assay specificity was demonstrated in 32 young healthy donors and clinical feasibility was demonstrated in a cohort of 47 subjects consisting of healthy donors and patients who were colonoscopy verified to have colorectal cancer, adenomas, or a negative result. The CMx platform demonstrated high accuracy, linearity, and sensitivity for the enumeration of all CLC concentrations tested, including the extremely low range of 1 to 10 cells in 2 mL of blood, which is most relevant for early cancer detection. Theoretically, the assay LOD is 0.71 CTCs in 2 mL of blood. The analytical specificity was 100% demonstrated using 32 young healthy donor samples. We also demonstrated precision across multiple days and multiple operators, with good reproducibility of recovery efficiency. In a clinical feasibility study, the CMx platform identified 8 of 10 diseased subjects as positive (80% clinical sensitivity) and 4 of 5 controls as negative (80% clinical specificity). We also compared processing time and transportation effects for similar blood samples from two different sites and assessed an artificial intelligence-based counting method. Finally, unlike other platforms for which captured CTCs are retained on ferromagnetic beads or tethered to the slide surface, the CMx platform's unique airfoam-enabled release of CTCs allows captured cells to be transferred from a microfluidic chip to an Eppendorf tube, enabling a seamless transition to downstream applications such as genetic analyses and live cell manipulations.

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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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