point-of-care diagnostic (POC)

  • 文章类型: Journal Article
    针对严重急性呼吸道综合症冠状病毒2型(SARS-CoV-2)等疾病的即时(POC)测试的有效供应链管理(SCM)需要不同利益相关者的积极参与,政府实体,和监管机构。负责监督POC测试的各个方面,包括采购,质量保证,storage,库存管理,分布,和人力资源能力,在于国家,省,和地方各级政府。这项研究旨在合作开发一种创新方法,以在资源有限的环境中增强SARS-CoV-2POC诊断服务的SCM,使用林波波省的莫帕尼区,南非,作为一个案例研究。
    主要利益相关者被邀请参加使用目的抽样的在线研讨会。研究采用名义分组技术(NGT)进行数据收集,由两个阶段组成。第一阶段侧重于识别COVID-19快速测试供应链中的障碍,而第二阶段旨在制定战略,克服第一阶段确定的优先障碍。参与者使用1-5的李克特量表对障碍和策略进行排名,并计算每个人的总体排名得分。向参与者提供了排名练习的结果,以获得反馈。
    来自国家(n=1)的11个主要利益相关者,省(n=4),和地方政府(n=2)级,研究实体(n=3),和非政府组织(n=1)参加了这项研究。参与者确定了供应链中的重大障碍,例如检测试剂盒的可用性,未知的需求,大流行期间关于SCM的信息,控制库存的方法,和采购流程。关键利益相关者建议的策略包括监控库存水平和优化库存可见性系统以提高测试可用性,增强信息可见性和一致的数据更新,以解决大流行期间的未知需求并改善SCM,采用数据捕获和数字化来进行有效的库存控制,并在国家一级实施需求规划和标准化采购流程,以加强库存采购。
    与关键利益相关者的成功合作,由NGT推动,共同创造了一种新的方法,在资源有限的环境中加强COVID-19诊断服务的SCM。这项研究有可能支持在这种情况下提供COVID-19诊断服务。建议进行的后续研究将评估实施这种方法的可行性。
    UNASSIGNED: Effective supply chain management (SCM) of point-of-care (POC) tests for diseases like severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) requires active participation from diverse stakeholders, government entities, and regulatory bodies. The responsibility for overseeing various aspects of POC tests, including procurement, quality assurance, storage, inventory management, distribution, and human resource capacity, lies with national, provincial, and local levels of government. This study aimed to collaboratively develop an innovative approach to enhance SCM for SARS-CoV-2 POC diagnostic services in resource-limited settings, using the Mopani District in Limpopo province, South Africa, as a case study.
    UNASSIGNED: Key stakeholders were invited to participate in an online workshop using purposive sampling. The study employed the nominal group technique (NGT) for data collection, which consisted of two phases. Phase 1 focused on identifying barriers in the supply chain of COVID-19 rapid tests, while phase 2 aimed to devise strategies to overcome the priority barriers identified in phase 1. Participants used a Likert scale of 1-5 to rank barriers and strategies, and an overall ranking score was calculated for each. The participants were provided with the results of the ranking exercise for their feedback.
    UNASSIGNED: Eleven key stakeholders from national (n = 1), provincial (n = 4), and local government (n = 2) levels, research entities (n = 3), and non-governmental organizations (n = 1) took part in the study. Participants identified significant barriers in the supply chain, such as the availability of testing kits, unknown demand, information on SCM during a pandemic, methods of controlling stock, and procurement processes. Strategies suggested by key stakeholders included monitoring stock levels and optimizing stock visibility systems to improve test availability, enhancing information visibility and consistent data updates to address unknown demand and improve SCM during a pandemic, employing data capturing and digitization for effective stock control, and implementing demand planning and standardized procurement processes at the national level to enhance stock procurement.
    UNASSIGNED: The successful collaboration with key stakeholders, facilitated by the NGT, resulted in the co-creation of a novel approach to enhance SCM for COVID-19 diagnostic services in resource-limited settings. This study holds the potential to support the provision of COVID-19 diagnostic services in such settings. A recommended follow-up study would assess the feasibility of implementing this approach.
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  • 文章类型: Journal Article
    基于表观遗传变化如DNA甲基化的诊断生物标志物是用于早期癌症诊断的有希望的工具。然而,在直接和特异性地检测甲基化的DNA区域中存在显著的困难。这里,我们报告了一种基于磁性纳米颗粒的电化学传感系统,该系统能够对甲基化的septin9(mSEPT9)基因进行定量和选择性分析,被认为是早期结直肠癌(CRC)的诊断标志物。与人类患者血清和血浆中的DNA片段杂交后,成功地跟踪了CRC样品中SEPT9的甲基化水平,并获得了相关肽核酸(PNA)的选择性识别能力(n=10)。此外,该系统也适用于一步检测平台的即时护理(POC)装置.mSEPT9的检测表明,在支链氨基酸转氨酶1(BCAT1)和SRY盒转录因子21反义发散转录物1(SOX21-AS1)存在下,检测限(LOD)值为0.37%,无干扰测量。当前提出的功能平台在早期CRC检测的转化应用中具有广阔的前景。
    Diagnostic biomarkers based on epigenetic changes such as DNA methylation are promising tools for early cancer diagnosis. However, there are significant difficulties in directly and specifically detecting methylated DNA regions. Here, we report an electrochemical sensing system based on magnetic nanoparticles that enable a quantitative and selective analysis of the methylated septin9 (mSEPT9) gene, which is considered a diagnostic marker in early stage colorectal cancer (CRC). Methylation levels of SEPT9 in CRC samples were successfully followed by the selective recognition ability of a related peptide nucleic acid (PNA) after hybridization with DNA fragments in human patients\' serums and plasma (n = 10). Moreover, this system was also adapted into a point-of-care (POC) device for a one-step detection platform. The detection of mSEPT9 demonstrated a limit of detection (LOD) value of 0.37% and interference-free measurement in the presence of branched-chain amino acid transaminase 1 (BCAT1) and SRY box transcription factor 21 antisense divergent transcript 1 (SOX21-AS1). The currently proposed functional platform has substantial prospects in translational applications of early CRC detection.
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