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Comparison of an automated digital cell morphology analysis system with manual counting 自动数字细胞形态分析系统与人工计数系统的比较
Pub Date : 2023-05-17 DOI: 10.1002/ila2.10
Juan Jiao, Xin Yin, Jiali Ma, Yinglong Xia, Jianxia Xu, Shaozhe Zhao, Jie Liu

Background

Bionovation's CSFA800 is a new automated digital cell imaging analyzer. We evaluated the performance of the CSFA800 by comparing it with artificial peripheral blood white blood cell counting.

Methods

According to inclusion and exclusion criteria, 131 randomly selected samples (77 abnormal samples and 54 normal samples) were compared. Correlations between automated and manual counting results were analyzed. Manual counting was carried out according to the guidelines of the Association of Clinical and Laboratory Standards.

Results

Counts of neutrophils, lymphocytes, monocytes, eosinophils, basophils, and immature granulocytes obtained from CSFA800 and artificial methods were linearly and positively correlated, with R values of 0.73, 0.65, 0.24, 0.2, 0.4, and 0.63, respectively, all p < 0.05. Therefore, correlations between CSFA800 and manual counting are acceptable. Compared with the DI-60 Automated Digital Cell Morphology System (DI-60; Sysmex), CSFA800 is more efficient and can analyze 20,000 cells in 1 min. However, the overall accuracy of CSFA800 is not as good as DI-60, although its counting performance is better for basophils.

Conclusions

The performance of CSFA800 for WBC counts is acceptable, and it displayed good performance for neutrophils, lymphocytes, and immature granulocytes. Compared to DI-60, CSFA800 is more efficient but has slightly lower overall accuracy. To some extent, CSFA800 is helpful to optimize the clinical laboratory workflow and improve the working efficiency of inspectors.

背景Bionovation的CSFA800是一种新型的自动化数字细胞成像分析仪。我们通过将CSFA800与人工外周血白细胞计数进行比较来评估其性能。方法根据纳入和排除标准,对随机抽取的131份样本(77份异常样本和54份正常样本)进行比较。分析了自动计数和手动计数结果之间的相关性。人工计数是根据临床和实验室标准协会的指导方针进行的。结果从CSFA800和人工方法中获得的中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞、嗜碱性粒细胞和未成熟粒细胞的计数呈线性正相关,R值分别为0.73、0.65、0.24、0.2、0.4和0.63,均为p<;0.05。因此,CSFA800和手动计数之间的相关性是可以接受的。与DI-60自动数字细胞形态学系统(DI-60;Sysmex)相比,CSFA800更高效,可以在1分钟内分析20000个细胞。然而,CSFA800的总体准确性不如DI-60,尽管它对嗜碱性粒细胞的计数性能更好。结论CSFA800对白细胞计数性能良好,对中性粒细胞、淋巴细胞和未成熟粒细胞具有良好的计数性能。与DI-60相比,CSFA800效率更高,但总体精度略低。在某种程度上,CSFA800有助于优化临床实验室工作流程,提高检查员的工作效率。
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引用次数: 0
Quality management in anatomic pathology: The past, present, and future 解剖病理学的质量管理:过去、现在和未来
Pub Date : 2023-05-15 DOI: 10.1002/ila2.7
Chenguang Xi, Dengfeng Cao

One of the challenges in anatomic pathology laboratories is to meet the increasing need for pathological diagnosis, using quality management (QM) activities and systems to ensure that patients receive their accurate and timely pathology report. The aim of this paper is to review anatomic pathology QM from both management and technical perspectives, including the past, present, and future opportunities. First, the evolution of the QM concept and scope will be discussed. Next, current QM system implementation and laboratory accreditations will be discussed from the management perspective, and common medical errors in anatomic pathology in different testing cycles will be analyzed. Finally, selected future management systems to improve the level of total QM worldwide for patient safety and the potential of informatics to be used as an auxiliary tool in anatomic pathology will be discussed.

解剖病理实验室面临的挑战之一是满足日益增长的病理诊断需求,使用质量管理(QM)活动和系统来确保患者收到准确及时的病理报告。本文的目的是从管理和技术的角度回顾解剖病理QM,包括过去、现在和未来的机会。首先,将讨论质量管理概念和范围的演变。接下来,将从管理的角度讨论当前QM系统的实施和实验室认证,并分析不同测试周期中解剖病理学中常见的医疗错误。最后,将讨论选定的未来管理系统,以提高全球患者安全的总体质量管理水平,以及信息学作为解剖病理学辅助工具的潜力。
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引用次数: 0
Research progress of CRISPR/Cas systems in nucleic acid detection of infectious diseases CRISPR/Cas系统在传染病核酸检测中的研究进展
Pub Date : 2023-05-13 DOI: 10.1002/ila2.6
Jinying Dong, Yuguang Du, Lei Zhou

Infectious diseases are a serious threat to human health, and accurate, rapid and convenient early detection of pathogens is the first step of active treatment. Technologies that detect pathogens have advanced significantly because of the development of fundamental disciplines and the integration of multidisciplinary fields. Among these technologies, nucleic acid detection technology is preferred because of its rapid measurement, accuracy and high sensitivity. The CRISPR/Cas system, consisting of Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) and CRISPR-associated (Cas), is an adaptive immune system that specifically recognizes, binds and cleaves exogenous invasive nucleic acids. The CRISPR/Cas system is widely found in bacteria and archaea. Researchers have developed nucleic acid detection technologies with single-molecule sensitivity, single-base precision specificity, portability and low cost based on the specific cleavage and trans-cleavage activities of the CRISPR/Cas system. The next generation of in-vitro diagnostics is shifting to nucleic acid technology because this technology shows promise in a wide range of applications in resource-constrained environments. In this review, the development and mechanism of the CRISPR/Cas system are presented together with representative CRISPR/Cas applications in nucleic acid detection. Additionally, the review summarizes future perspectives and trends of the CRISPR/Cas system in nucleic acid detection.

传染病是对人类健康的严重威胁,准确、快速、方便的病原体早期检测是积极治疗的第一步。由于基础学科的发展和多学科领域的融合,检测病原体的技术取得了显著进步。在这些技术中,核酸检测技术因其快速、准确和高灵敏度而受到青睐。CRISPR/Cas系统由簇状规则间隔短回文重复序列(CRISPR)和CRISPR相关序列(Cas)组成,是一种特异性识别、结合和切割外源性入侵核酸的适应性免疫系统。CRISPR/Cas系统广泛存在于细菌和古菌中。研究人员基于CRISPR/Cas系统的特异性切割和反式切割活性,开发出了具有单分子灵敏度、单碱基精确特异性、便携性和低成本的核酸检测技术。下一代体外诊断正在转向核酸技术,因为这项技术在资源受限的环境中显示出广泛的应用前景。在这篇综述中,介绍了CRISPR/Cas系统的发展和机制,以及CRISPR/Cas在核酸检测中的代表性应用。此外,综述了CRISPR/Cas系统在核酸检测中的未来前景和趋势。
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引用次数: 1
Bottlenecks and recent advancements in detecting Mycobacterium tuberculosis in patients with HIV HIV患者结核分枝杆菌检测的瓶颈和最新进展
Pub Date : 2023-05-10 DOI: 10.1002/ila2.11
Zixun Lin, Liqin Sun, Cheng Wang, Fuxiang Wang, Jun Wang, Qian Li, Hongzhou Lu

Tuberculosis (TB) remains a leading cause of deaths among patients with acquired immunodeficiency syndrome patients. Early diagnosis of TB is essential for administering timely anti-TB therapy and improving health outcomes, particularly in the people living with HIV. However, conventional techniques used to detect Mycobacterium tuberculosis have significant drawbacks: for example, sputum smear microscopy has low sensitivity, and liquid culture is time-consuming in patients with HIV-TB co-infection due to low sputum production. In addition, while immunological-based methods involving tuberculin skin testing and interferon gamma release assays are commonly used for auxiliary TB diagnosis, they are often inaccurate in immunodeficient patients. Molecular techniques such as line probe assays, Xpert MTB, and lipoarabinomannan assay are recommended for early diagnosis by World Health Organization. However, no single technique is sufficicent for diagnosing HIV/TB co-infection, suggesting that multiple diagnostic tests should be used to detect TB. Here, we summarize the drawbacks and advantages of existing TB-diagnostic methods, as well as their applications to diagnosing HIV/TB co-infection. We describe newly emerging technologies such as whole genome sequencing and mass spectrometry, with the aim of providing updated guidelines and alternative strategies for TB diagnosis, and particularly HIV/TB diagnosis.

肺结核仍然是导致获得性免疫缺陷综合征患者死亡的主要原因。结核病的早期诊断对于及时进行抗结核病治疗和改善健康状况至关重要,尤其是对艾滋病毒感染者而言。然而,用于检测结核分枝杆菌的传统技术有显著的缺点:例如,痰涂片显微镜的灵敏度较低,并且由于痰液产量低,液体培养在HIV-TB合并感染的患者中耗时。此外,虽然结核菌素皮肤试验和干扰素γ释放试验等基于免疫学的方法通常用于辅助结核病诊断,但它们在免疫缺陷患者中往往不准确。世界卫生组织建议使用分子技术,如线探针分析、Xpert MTB和阿拉伯糖醛酸脂质分析进行早期诊断。然而,没有单一的技术足以诊断HIV/TB合并感染,这表明应使用多种诊断测试来检测TB。在此,我们总结了现有结核病诊断方法的缺点和优点,以及它们在诊断HIV/TB合并感染中的应用。我们介绍了新出现的技术,如全基因组测序和质谱分析,目的是为结核病诊断,特别是艾滋病毒/结核病诊断提供最新的指南和替代策略。
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引用次数: 0
Single cell metabolic phenome and genome via the ramanome technology platform: Precision medicine of infectious diseases at the ultimate precision? 通过ramanome技术平台的单细胞代谢现象和基因组:传染病精准医学的终极精度?
Pub Date : 2023-05-09 DOI: 10.1002/ila2.12
Jian Xu, Jianzhong Zhang, Yingchun Xu, Yi-Wei Tang, Bo Ma, Yuzhang Wu

Due to the limitations of existing approaches, a rapid, sensitive, accurate, comprehensive, and generally applicable strategy to diagnose and treat bacterial and fungal infections remains a major challenge. Here, based on the ramanome technology platform, we propose a culture-free, one cell resolution, phenome-genome-combined strategy called single-cell identification, viability and vitality tests and source tracking (SCIVVS). For each cell directly extracted from a clinical specimen, the fingerprint region of the D2O-probed single cell Raman spectrum (SCRS) enables species-level identification based on a reference SCRS database of pathogen species, whereas the C-D band accurately quantifies viability, metabolic vitality, phenotypic susceptibility to antimicrobials, and their intercellular heterogeneity. Moreover, to source track a cell, Raman-activated cell sorting followed by sequencing or cultivation proceeds, producinging an indexed, high coverage genome assembly or a pure culture from precisely one pathogenic cell. Finally, an integrated SCIVVS workflow that features automated profiling and sorting of metabolic and morphological phenomes can complete the entire process in only a few hours. Because it resolves heterogeneity for both the metabolic phenome and genome, targets functions, can be automated, and is orders-of-magnitude faster while cost-effective, SCIVVS is a new technological and data framework to diagnose and treat bacterial and fungal infections in various clinical and disease control settings.

由于现有方法的局限性,诊断和治疗细菌和真菌感染的快速、敏感、准确、全面和普遍适用的策略仍然是一个重大挑战。在这里,基于ramanome技术平台,我们提出了一种无培养、单细胞分辨率、现象基因组组合策略,称为单细胞鉴定、活力和活力测试以及来源跟踪(SCIVVS)。对于直接从临床标本中提取的每个细胞,D2O探测的单细胞拉曼光谱(SCRS)的指纹区能够基于病原体物种的参考SCRS数据库进行物种水平的鉴定,而C-D带准确地量化了生存能力、代谢活力、对抗菌剂的表型易感性及其细胞间异质性。此外,为了来源追踪细胞,进行拉曼激活的细胞分选,然后测序或培养,从一个致病细胞中产生索引的、高覆盖率的基因组组装或纯培养物。最后,一个集成的SCIVVS工作流程,以代谢和形态现象的自动分析和排序为特色,可以在几个小时内完成整个过程。由于它解决了代谢现象和基因组的异质性,靶向功能,可以自动化,速度快几个数量级,同时具有成本效益,SCIVVS是一种新的技术和数据框架,用于在各种临床和疾病控制环境中诊断和治疗细菌和真菌感染。
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引用次数: 0
Clinical application of intelligent technologies and integration in medical laboratories 智能技术的临床应用及其在医学实验室的集成
Pub Date : 2023-05-09 DOI: 10.1002/ila2.9
Wenjie Huang, Dongquan Huang, Yeran Ding, Cheng Yu, Lei Wang, Ning Lv, Jiuxin Qu, Hongzhou Lu

With the development of scientific technology, the transition to the intelligent era of digitalization and automation is an irresistible trend for medical laboratories. Medical diagnosis systems have undergone significant changes as a result of intelligent technologies, such as machine learning, artificial intelligence, and the Internet of Things, from the collection, transmission, and detection of test samples to the review of reports and the provision of clinical feedback. In addition to significantly enhancing the efficiency, consistency, and accuracy of medical laboratory testing, these technologies also assist the improvement of individualized healthcare and medical expert systems, as well as the early detection and treatment of diseases. The future development of medical laboratories will focus on integrating big data and diverse intelligent resources, cooperating more closely with clinical departments, and realizing the effective pathway of patient-centered care. The purpose of this review is to illustrate the current state of intelligent technology integration in medical laboratories and provide a preliminary discussion about the potential future influences of intelligent technology development on the evolution of medical laboratories.

随着科学技术的发展,向数字化和自动化的智能时代过渡是医学实验室不可阻挡的趋势。由于机器学习、人工智能和物联网等智能技术,从检测样本的收集、传输和检测到报告的审查和临床反馈,医疗诊断系统发生了重大变化。除了显著提高医学实验室检测的效率、一致性和准确性外,这些技术还有助于改善个性化医疗保健和医学专家系统,以及疾病的早期检测和治疗。医学实验室的未来发展将侧重于整合大数据和多样化的智能资源,与临床部门更紧密地合作,实现以患者为中心的护理的有效途径。本综述的目的是说明医学实验室智能技术集成的现状,并初步讨论智能技术发展对医学实验室发展的潜在影响。
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引用次数: 0
iLABMED, why now and how in the future? iLABMED,为什么是现在,未来如何?
Pub Date : 2023-03-28 DOI: 10.1002/ila2.5
Hongzhou Lu

Nowadays, public health is facing many challenges, mainly including non-communicable diseases and communicable diseases. Communicable diseases, particularly emerging infectious diseases, have also attracted attention due to their enormous impact on public health and the global economy. The most prominent example is the current global Coronavirus Disease 2019 (COVID-19) pandemic. The unprecedented and ongoing COVID-19 pandemic has highlighted the necessity for readily available, accurate, and rapid laboratory medicine (LM) practices. Nevertheless, current LMs and journals in particular have a window for improvement. First, there are limited numbers of professionals available in this field compared to the other disciplines. The current status quo is that most LM manuscripts must be submitted to comprehensive journals or other journals related to the research disease. Second, most LM journals are run by laboratory personnel who are often more concerned with technical advances than with clinical needs. Lastly, several young LM scientists expressed their desire to have a dedicated platform to discuss, communicate, and publish their works on LM. We were therefore motivated to launch iLABMED, an international public forum dedicated to LMs. The establishment of iLABMED adopts the “four I” strategy, namely “Innovation,” “Intelligence,” “Integration,” and “International.” We are attempting to establish a top-tier journal in the field of LM.

如今,公共卫生面临许多挑战,主要包括非传染性疾病和传染性疾病。传染病,特别是新出现的传染病,由于对公共卫生和全球经济的巨大影响,也引起了人们的关注。最突出的例子是当前全球2019冠状病毒病(新冠肺炎)大流行。前所未有和持续的新冠肺炎大流行突出了提供现成、准确和快速的实验室医学(LM)实践的必要性。尽管如此,当前的LMs和期刊尤其有改进的窗口。首先,与其他学科相比,该领域的专业人员数量有限。目前的现状是,大多数LM手稿必须提交给综合期刊或其他与研究疾病相关的期刊。其次,大多数LM期刊由实验室人员运营,他们通常更关心技术进步,而不是临床需求。最后,几位年轻的LM科学家表示,他们希望有一个专门的平台来讨论、交流和发表他们在LM上的作品。因此,我们有动力推出iLABMED,这是一个致力于LMs的国际公共论坛。iLABMED的创办采用“四个I”战略,即“创新”、“智能”、“融合”和“国际化”。我们正在努力建立LM领域的顶级期刊。
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引用次数: 0
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iLABMED
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