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Apostle MiniMax 技术


概述

高效地分离和分析极低浓度的游离DNA (cfDNA)，在生物医学领域正变得越来越重要，尤其是应用于无创产检（NIPT）、肿瘤的早期筛查和随访、感染性疾病等重要的科研和临床领域。在复杂的生物样本中首先对cfDNA进行高效分离，是随后对其进行有效分析的至关重要一步。与其他传统技术相比，Apostle MiniMax 技术具有全球领域内表现最佳的cfDNA 捕获、分离、纯化的效率和纯度。这一极佳的能力，在全球领域内被广泛地验证和应用。

客户评价、引用、报道和反馈

【Cancer Cell】Tumor- and circulating-free DNA methylation identifies clinically relevant small cell lung cancer subtypes
"These data establish that tumor and cfDNA methylation can be used to identify SCLC subtypes and might guide precision SCLC therapy. "..."(Methods section) cfDNA was extracted using the Apostle MiniMax High Efficiency Cell-Free DNA Isolation Kit (Apostle Inc). " ..."(Key Resources Table - Critical commercial assays) Apostle MiniMax High Efficiency Cell-Free DNA Isolation Kit. Apostle Bio A17622-250 "
- 发表于 Cell 子刊 Cancer Cell（影响因子 50.3） 的独立临床研究，作者第一单位: MD Anderson癌症中心
【Nature Communications】 Integrative modeling of tumor genomes and epigenomes for enhanced cancer diagnosis by cell-free DNA
"Our integrative model detects early-stage cancers, including those of pancreatic origin, with high sensitivity that is comparable to that of late-stage detection. "..."(Methods section) cfDNA was extracted from 0.4 mL plasma ... and eluted in a final volume of 22 μL, using an Apostle MiniMax High Efficiency cfDNA Isolation Kit (Apostle, US) according to the manufacturer’s instructions. "
- 发表于 Nature Communications 的独立临床研究
【Nature Medicine】 Individualized, heterologous chimpanzee adenovirus and self-amplifying mRNA neoantigen vaccine for advanced metastatic solid tumors: phase 1 trial interim results
"Exploratory biomarker analyses showed decreased circulating tumor DNA (ctDNA) in patients with prolonged OS... cfDNA was extracted from the entire plasma volume of a single draw using the Apostle MiniMax cfDNA Isolation kit (ApostleBio) "
- 发表于 Nature Medicine 的独立临床试验，参与单位： 美国Gritstone, 美国哥伦比亚大学医学院，美国梅奥诊所，美国MSKCC 纪念斯隆凯特琳癌症中心，美国MD Anderson癌症中心。
【Science Translational Medicine】Simultaneous analysis of mutations and methylations in circulating cell-free DNA for hepatocellular carcinoma detection
"The model detected four of the five HCC cases in the cohort, showing 80% sensitivity and 94% specificity. These findings demonstrate that the MCP technology has potential for the discovery and validation of multiomics biomarkers for the noninvasive detection of cancer. This study also provides a comprehensive database of genetic and epigenetic alterations in the cfDNA of a large cohort of HCC cases and high-risk non-HCC individuals." "cfDNA was extracted from the plasma samples using the Apostle MiniMax cfDNA isolation kit (C43468, Apostle). "
- 发表于 Science Translational Medicine 的独立临床研究，参与单位：中国国家癌症中心，泛生子等
【Nature Medicine】Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial
"In this study, we administered a recombinant bicistronic adeno-associated virus (AAV8) vector coding for both the light and heavy chains of the potent broadly neutralizing HIV-1 antibody VRC07 (AAV8-VRC07) to eight adults living with HIV... Plasma AAV8-VRC07 plasmid DNA was measured by extracting DNA from plasma,... DNA was extracted from serum using an Apostle MiniMax High Efficiency cfDNA Isolation Kit, following the manufacturer’s protocol with slight modification."
- 发表于 Nature Medicine 的独立临床试验，参与单位：美国NIH, 美国南卡罗莱纳大学医学院，美国麻省理工学院和哈佛大学，美国加州理工，美国杜克大学，美国Vaxart, 以及ModeX。
"The mqMSP assay is cost-effective and easily implementable for routine clinical monitoring of CRC recurrence, which can lead to better patient management after surgery... Plasma DNA extraction was performed using 2 to 5 mL of plasma with the Apostle MiniMax High-Efficiency cfDNA Isolation Kit, according to the product manual. "
- 一项独立临床研究，发表于 PNAS
(Figure 4) "Most notably, the Apostle particles outperformed all others, achieving almost 2-fold higher recovery yields than the particles supplied in the X kit".
- 一项发表在 SLAS Technology 上的独立临床研究，参与单位：美国约翰霍普金斯大学，匹兹堡大学
"This illustrates a 34.3% higher yield when using the Apostle kit as compared to the X kit." "This data demonstrates an average of 14.8% higher yield using the Apostle kit." "The Apostle mononucleosomal cfDNA yield was 70.0% higher than the yield for the X samples." "A summary provided in Table 2 shows the consistently higher yield achieved by the Apostle MiniMax High Efficiency cfDNA Isolation Kit as compared to the X circulating nucleic acid kit. The average 40% improvement in yield underscores the importance of extraction kit selection in cfDNA assay development and highlights the potential impact of cfDNA isolation efficiency in ctDNA detection."
- 一项独立比较研究，作者：美国贝克曼库尔特公司 (文献全文)
"We used SMS-based NIPS to screen for common fetal aneuploidies in 477 pregnant women." "Compared with NGS, SMS (without PCR) had less GC bias, a better distinction between T21 or T18 and euploidies, and better diagnostic performance. " "cfDNA was extracted from 0.6 mL of maternal plasma using Apostle MiniMax High-Efficiency cfDNA Isolation Kit (ref. number: A17622-50; Apostle) according to the manufacturer’s instructions."
- 一项发表在 Laboratory Investigation 上的独立临床研究，参与单位：浙江大学医学院附属妇产科医院，教育部生殖遗传重点实验室，等
"...Elucidating the relationship between these pathways and the increased circulating mitochondrial DNA observed here will provide further insight into the cell-damaging effects of prolonged inhalation of e-cigarette aerosols. " "For measurement of in vivo plasma mtDNA/nDNA ratio, mice plasma was first subjected to cell-free DNA (cfDNA) extraction using Apostle minimax cfDNA extraction kit (ApostleBio, CA, US). "
- 一项发表于 American Journal of Cancer Research 美国癌症研究杂志 的独立临床研究，参与单位：美国耶鲁大学
"H3K36me3 cfChIP-seq demonstrated increased enrichment of mutated alleles compared to normal alleles in plasma from patients with known somatic cancer mutations." "Findings here expand the utility of cfDNA in liquid biopsies to characterize treatment resistance, cancer subtyping, and disease progression." "Both the input as well as the cfChIP samples were purified using Apostle MiniMax High Efficiency cfDNA Isolation Kit (Beckman Coulter, Indianapolis, IN, USA) according to manufacturer’s instructions."
- 一项发表于 Molecular Oncology 的独立临床研究，作者单位： Department of Clinical Biochemistry, Aarhus University Hospital, and Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
"Plasma cell-free DNA (cfDNA) from 2821 myeloid or lymphoid neoplasm patients were collected. cfDNA was sequenced using a 275 gene panel... This data shows that liquid biopsy using targeted NGS is reliable in detecting chromosomal structural abnormalities in myeloid neoplasms...Overall, this study supports the use of liquid biopsy for early diagnosis and monitoring of patients with myeloid neoplasms...We extracted cfDNA from 2821 peripheral blood samples using the Apostle MiniMax High Efficiency cfDNA Isolation Kit (San Jose, CA). "
- 发表于 Frontiers in Oncology 的独立临床研究，参与单位：美国Hackensack University Medical Center, Ernest Mario School of Pharmacy at Rutgers University, Englewood Health Internal Medicine Residency Program, 以及Genomic Testing Cooperative。
(Figure 1) "For each tube the Apostle MiniMax extracted higher total yield of DNA".
- 一项独立研究，作者：美国贝克曼库尔特公司 (文献全文)
As a proof-of-concept, we developed a 222-plex Ultra-dPCR assay and demonstrated its potential use as a rapid, low-cost screening assay for non-invasive prenatal testing (NIPT) for as low as 4% trisomy fraction samples with high precision, accuracy, and reproducibility...Cell-free plasma was isolated using the Apostle MiniMax kit (Beckman Coulter) according to the manufacturer’s protocol with an elution volume of 60 μL.
- 一项发表于 Analytical Chemistry 的独立研究，参与单位：Enumerix
"We developed a ddPCR assay to quantify the T790M mutation in plasma. Quantification of longitudinal plasma T790M mutation may allow noninvasive assessment of drug resistance and guide follow-up treatment in TKI-treated patients with NSCLC....cfDNA was extracted from 2–6 ml of plasma using an Apostle MiniMax High Efficiency cfDNA Isolation Kit (standard edition) (Apostle, Silicon Valley, CA, USA) according to the manufacturer’s instructions. "
- 一项发表于 Targeted Oncology 的独立临床研究
"...This includes recognizing that an innovative product from Apostle is the best technology to address these needs."
- Steve Wowk, 美国贝克曼库尔特公司，基因组学总监
"The combination of mutation profiling and CNA profiling can improve the detection of MRD, which may help optimize the treatment strategies for patients with locally advanced rectal cancer (LARC)...cfDNA was extracted from 1.5-4.5 mL of plasma with the Apostle MiniMax cfDNA isolation kit (C40605, Apostle; San Jose, CA, USA). "
- 一项发表于 EBioMedicine 的独立临床研究，参与单位：北京协和医学院，中山大学癌症中心，等
"Our study confirmed that SD regions are preferred biomarkers for aneuploidy detection and in particular SD-based digital PCR could find potential use for NIPT of trisomy... The cfDNA was isolated from 1 mL of each plasma sample by the Apostle MiniMax™ High Efficiency cfDNA Isolation Kit (Apostle Inc, San Jose, CA). "
- 一项发表于 EBioMedicine 的独立临床研究，作者单位：厦门大学分子疫苗学和分子诊断学国家重点实验室

国际独立评价数据

Apostle MiniMax 技术用于分离循环游离核酸具有全球表现最优的效率和纯度。这一极佳的表现为全球顶尖的学术、企业机构反复比较、验证、发表，因此越来越多的国际领先机构在实际工作中应用 Apostle MiniMax 技术。下面是一些独立国际组织发表的评测数据举例。更多的客户数据、文献、引用在这里。


优异表现 - 头对头比较数据



Results and discussion

Mean cfDNA concentrations in the eluates were determined to be 8.30 ng/μL for samples extracted with the QIAamp kit and 11.15 ng/μL for samples extracted with the Apostle kit when measured with the Qubit assay (Figure 1A). This illustrates a 34.3% higher yield when using the Apostle kit as compared to the QIAamp kit.

When evaluating the contents of specific genes in the eluate, the Apostle purification displayed a higher yield than QIAamp (Figure 1B). 8358 DNAJC5G positive droplets were detected in the Apostle samples compared to 7269 droplets in the QIAamp samples. Similarly, 10849 ACTG1 droplets were detected in the Apostle-extracted samples versus 9463 droplets detected in the QIAamp-extracted samples. This data demonstrates an average of 14.8% higher yield using the Apostle kit.

Finally, when evaluating cfDNA fragments via the Agilent bioanalyzer instrument, the Apostle kit demonstrated the highest yield (Figure 1C and D). Mononucleosomal cfDNA concentration in the eluate of Apostle samples was estimated to be 10.64 ng/μL versus 6.26 ng/μL in the eluate of QIAamp samples. The dinucleosomal cfDNA concentration was low for both kits, with 0.13 ng/μL recorded for Apostle samples and 0.24 ng/μL for QIAamp samples. This indicates a slightly better purification of dinucleosomal cfDNA using QIAamp; however, this could also be an artifact given the low concentrations. The Apostle mononucleosomal cfDNA yield was 70.0% higher than the yield for the QIAamp samples.

Publication: Comparative analysis of cell-free DNA extraction efficiency from plasma.  Beckman Coulter Life Sciences. Indianapolis, IN. Technical Note 2022.


A summary provided in Table 2 shows the consistently higher yield achieved by the Apostle MiniMax High Efficiency cfDNA Isolation Kit as compared to the QIAamp® circulating nucleic acid kit. The average 40% improvement in yield underscores the importance of extraction kit selection in cfDNA assay development and highlights the potential impact of cfDNA isolation efficiency in ctDNA detection.


Publication: Comparative analysis of cell-free DNA extraction efficiency from plasma.  Beckman Coulter Life Sciences. Indianapolis, IN. Technical Note 2022.

 

(Figure 4) - "Most notably, the Apostle particles outperformed all others, achieving almost 2-fold higher recovery yields than the particles supplied in the Qiagen kit. "

Publication:  High-throughput sample processing for methylation analysis in an automated, enclosed environment.  Stark et al. SLAS Technology 2022; 27(3):172-179. 


Publication:  Optimization of high-volume cell free DNA extraction and end-to-end automation for TSO 500 ctDNA library prep [abstract]. Nripesh Prasad, Rachel Rock, Rebecca Beatty, Melanie Robinson, Dineen Wildman, Michael Sykes, Boris Umylny, Thomas Halsey. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2298. 



Figure 1. cfDNA extraction method affects allele frequency (AF%). EGFR L858R standards with AF% of 0.3%, 1.0%, and 3.0% were spiked into plasma and isolated using Product A (red) or Apostle MiniMax cfDNA isolation kit (blue and green). The eluates were analyzed by NGS (performed by the Institute B) following standard protocol and AF% calculated using their established workflow. cfDNA isolated by Apostle MiniMax cfDNA isolation kit shows higher concordance between detected AF% and expected AF%.

Publication: cfDNA Extraction Efficiency Affects NGS Data.   Beckman Coulter Life Sciences. Indianapolis, IN. Technical Note 2020.




(Figure 1) "For each tube the Apostle MiniMax extracted higher total yield of DNA. "


Publication: cfDNA Extraction from Plasma for Liquid Biopsy: Apostle MiniMaxTM High Efficiency cfDNA Isolation Kit. Beckman Coulter Life Sciences, Data Sheet. 2019. 



(Note: Table 13 referenced below in this diploma thesis shows that Apostle MiniMax yields the greatest number of analyzable drops in the digital PCR.)


Publication. Optimalizace digitální polymerázové řetězové reakce pro aplikaci v neinvazivní prenatální diagnostice (Optimization of digital polymerase chain reaction for application in non-invasive prenatal diagnostics) Author: Šenkyřík, Pavel; Advisor: Korabečná, Marie; Referee: Vodička, Radek; Faculty / Institute: Faculty of Science; Discipline: Anthropology and Human Genetics; Department: Department of Anthropology and Human Genetics; Date of defense: 13. 9. 2022; Publisher: Univerzita Karlova, Přírodovědecká fakulta;  Language: Czech

应用

Apostle MiniMax 技术在许多国际领先的临床研究、临床实验室检测、公共卫生项目中广泛应用。这里是更完整的讨论。下面是其中一些案例。 

Apostle MiniMax 技术在多种肿瘤早期检测临床研究中的应用（发表于Nature Communications）

Apostle MiniMax 技术在转移性实体瘤临床研究中的应用（发表于Nature Medicine）

Apostle MiniMax 技术在肝细胞肝癌检测中的应用（发表于Science Translational Medicine）

Apostle MiniMax 技术在HIV临床研究和临床试验中的应用（发表于Nature Medicine）

Apostle MiniMax 技术在结肠癌临床检测和术后监控研究中的应用（发表于PNAS）

Apostle MiniMax 技术在骨髓增殖性肿瘤患者中检测染色体结构变异研究中的应用

Apostle MiniMax 技术在直肠癌用药指导、风险分层临床研究中的应用

Apostle MiniMax 技术在无创产检（NIPT）中的应用

Apostle MiniMax 技术在使用数字液滴PCR（ddPCR）进行无创产检（NIPT）研究中的应用

Apostle MiniMax 技术在美国胎儿性别临床检测中的应用

Apostle MiniMax 技术在心血管疾病临床研究中的应用

Apostle MiniMax 技术在新一代数字PCR研究中的应用

技术关键性

2017年12月在 JAMA Oncology 上由 Torga 和 Pienta 发表的一篇文章 报道液体活检显示显著的结果不一致性和差异。 为什么液体活检结果差异如此巨大？这种先进的检测技术是否可靠？ 

这里影响因素很多，但从检验材料的角度看，cfDNA 的有效抽提扮演极其重要的角色，也是这个重要方法的第一环。数据显示，在不同的方法下， cfDNA抽提的量可以相差10%-10倍或更多，导致显著的结果不一致性和结论差异。在核内基因组 DNA 微克级别的时代， 10%-10倍量的差别没有太多意义，因为拷贝数过饱和， 检验方法总有足量的核酸材料； 而在cfDNA 的纳克级，通常是 <100ng 的时代，10%-10倍的差别则有重大意义，影响着可检测的突变拷贝数、检出率、信噪水平，从而对液体活检实验结果有重大影响。 cfDNA纳克级别上的量变可以导致液体活检检测结果的质变。在一定前提下，cfDNA抽提低效，导致液体活检完全失去检测意义，还不如直接掷硬币猜正反面。 这是一个数学命题，示例如图。与其他影响因素一起，高效率cfDNA 抽提是成功的液体活检体系的第一个，也是关键的一个环节。 

要想取得稳定、成功的液体活检，必须首先取得高效的cfDNA抽提。

图 1. cfDNA 抽提效率影响液体活检示例


原创性和独特性

Apostle MiniMax 纳米磁珠技术确保在液体活检和 NIPT 中对低丰度遗传物质的富集检测，有高敏感度、高可重复性的优异表现。 这是因为，Apostle的专利技术具备以下原创性的技术特点 ( 图2 - 图8):


  • 原创的内部组成和表面化学-与传统的超顺磁技术根本不同
  • 更大的比表面积
  • 杰出的均一粒径分布
  • 杰出的悬浮特性
  • 杰出的磁性
  • 杰出的抗粒子聚集性


    图 2. Apostle MiniMax纳米磁珠扫描电子显微镜图像（美国斯坦福大学电镜中心）

    与市场上其他传统磁珠相比，Apostle专利MiniMax纳米磁珠拥有卓越的均一度，极强的磁性，从而保证其悬浮状态更稳定，磁力反应更迅速。 更为突出的是，MiniMax纳米磁珠独创性的表面化学性质使得从复杂生物样本中快速捕获和富集极低浓度遗传物质成为易事。

    图 3. Apostle MiniMax纳米磁珠杰出的均一度

    Apostle专利MiniMax纳米磁珠具备无与伦比的均一粒径分布。市场上其他传统磁珠则分布不规则，且混有大量的多聚体。Apostle MiniMax杰出的均一粒径分布确保高度可重复的高效率游离遗传物质富集和分离检测。

    视频 4. Apostle MiniMax纳米磁珠杰出的悬浮性能

    良好的悬浮性能，对有效分离细胞游离DNA非常重要。在这个直观的小实验中，我们对比了Apostle MiniMax纳米磁珠和其他两种国际领先的磁珠技术。 三管中磁珠的重量相等，同时开始静置。在1分钟时，其他国际领先磁珠技术 2 几乎完全沉淀；在15分钟时， 其他国际磁珠技术 1 几乎完全沉淀。而 Apostle MiniMax纳米磁珠始终保持悬浮状态，展现卓越的悬浮性能。


    视频网址：https://www.youtube.com/watch?v=ym63t4oLnkQ

    图 5. Apostle MiniMax纳米磁珠杰出的磁性

    强大的磁性，对有效分离细胞游离DNA同样非常重要。在这个直观的小实验中，我们对比了Apostle MiniMax纳米磁珠和其他两种国际其他的磁珠技术的磁性。三管中磁珠的重量相等。 一块磁板等距离向三管缓慢移动。三管中谁的磁性最强烈，谁先被磁板吸引而移动。Apostle MiniMax纳米磁珠管首先移动，而国际其他磁珠技术 1、2 均没有位移。 Apostle MiniMax纳米磁珠展现卓越的磁性。

    图 6. Apostle MiniMax纳米磁珠杰出的抗聚集性

    Apostle专利MiniMax纳米磁珠具备无与伦比的抗聚集性。在这个小实验中，我们对比了Apostle MiniMax纳米磁珠和其他国际先进磁珠技术的抗聚集性。 两管中磁珠的重量相等。在加入异丙醇后，Apostle MiniMax纳米磁珠没有任何磁珠聚集。而国际其他磁珠技术出现肉眼可见的磁珠聚集。 磁珠聚集会显著干扰对细胞游离核酸物质的提取，甚至干扰整个实验。Apostle MiniMax纳米磁珠展现卓越的抗聚集性。 

    高分辨率大图

    图 7. 人血浆、尿液中高效、无偏差的cfDNA富集

    A) 在人血浆中，Apostle MiniMaxTM 高效游离DNA富集分离试剂盒（红线）与传统磁珠技术市场领导者（蓝线）比较，显示显著更优的cfDNA富集产率。 人外周血液首先在2000g 4oC离心10分钟以获得血浆；血浆随后在16000g 4oC离心10分钟以去除细胞杂质。以Apostle MiniMaxTM 纳米磁珠（红线）与传统磁珠技术市场领导者（蓝线）分别于4mL去杂质血浆中分离cfDNA。结果测量自 BioAnalyzer 2100 (Agilent)。 

    B) 在人尿液中，Apostle MiniMaxTM 高效游离DNA富集分离试剂盒（红线）与传统磁珠技术市场领导者（蓝线）比较，显示显著更优的cfDNA富集产率。 人尿液在16000g 4oC离心10分钟以去除细胞杂质。以Apostle MiniMaxTM 纳米磁珠（红线）与传统磁珠技术市场领导者（蓝线）分别于20mL去杂质尿液中分离cfDNA。结果测量自 BioAnalyzer 2100 (Agilent)。

    图 8. 使用Apostle MiniMax 高效游离DNA富集分离技术得到优秀的DNA突变检测结果

    20 uL 不同浓度 （1 ng/uL, 0.1 ng/uL, 0.01 ng/uL, 0.001 ng/uL） 的 EGFR c.2573T>G L858R DNA突变片段 (~170 bp) 分别加入 1mL TE 溶液 (蓝色) 或血清 (红色)。使用Apostle MiniMaxTM 高效游离DNA富集分离试剂盒对突变DNA片段进行富集分离，终体积为20 uL 。 使用1 uL 富集分离液，以及 1 uL 各浓度下原液，进行qPCR并进行对比。 


    A) 扩增图（Amplification plot）显示各浓度下突变DNA片段原液与Apostle MiniMaxTM 高效游离DNA富集分离液高度重合的曲线。 


    B) 使用突变DNA片段原液产生的 qPCR 标准曲线用以定量Apostle MiniMaxTM 高效游离DNA富集分离的DNA片段。 在各浓度下，突变DNA检测均实现高效回收，回收率均 >90%。 


    注：图示的DNA浓度梯度 1, 0.1, 0.01, 0.001 ng/ul 是DNA突变片段原液在加入1mL血清之前的浓度。相对应的游离DNA富集分离的实际工作浓度分别为：20 pg/ul, 2 pg/ul, 0.2 pg/ul, 0.02 pg/ul。

    Other Information

    艾铂图 Apostle 与生命科学领域的国际领导者之一，美国贝克曼库尔特(Beckman Coulter)公司战略合作*， 在全球共同推广Apostle MiniMax 敏迈高效游离核酸抽提试剂盒。

    订购或了解更多产品信息，请访问 Beckman Coulter's 官方网站:

    Apostle image 
    https://www.beckman.com/reagents/genomic/dna-isolation/from-plasma

    关于 Apostle-Beckman Coulter 战略合作的更多信息，请访问Beckman Coulter's 官方新闻发布:  https://www.beckman.com/news/liquid-biopsy-partnership-with-apostle

    产品Cat#
    Apostle MiniMaxTM 高效游离DNA富集分离试剂盒 (标准版) (1mL X 10 preps)A17622-10
    Apostle MiniMaxTM 高效游离DNA富集分离试剂盒 (标准版) (1mL X 50 preps)A17622-50
    Apostle MiniMaxTM 高效游离DNA富集分离试剂盒 (标准版) (5mL X 50 preps)A17622-250
    For research use only. Not for use in diagnostic procedures.
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