用于测量外周血白细胞的床旁测试分析仪的评估
2022年3月22日
这里介绍了使用基于 POCT 卡的白细胞分析仪测量外周血白细胞的方案。用两台自动血液分析仪测试相同的血液样本，以评估结果的一致性和准确性。结果表明，所评价的分析器与参比系统具有良好的相关性。
在协议中对分析仪标准化操作的详细说明可以帮助从未操作过分析仪的人完成最重要，准确和具有可靠结果的实验。使用Jove的创新技术具有诸如单人检测套件的可用性，无液体浪费，快速，免费日常维护以及用户友好操作等优点。首先要了解分析仪的检测原理，然后熟悉方案中的几个关键步骤，如采血、试剂提升等。
要开始启动分析仪，请关闭分析仪背面的关闭或电源开关，以确保分析仪的指示灯亮起。在登录对话框中输入用户名和密码，然后单击登录。系统应执行自检并自动启动初始化，并显示样本分析页面。
通过单击下一个样品开始测试准备，然后正确输入性别，名称和其他临床信息，并选择适当的参考组。稍后，单击"确定"以保存信息。撕下血细胞检测模块的薄膜，按下出入库按钮，将血细胞检测模块正确放入机器仓库，其孔口朝外。
用定量移液器的尖端刺穿溶血试剂天花板膜。对于毛细血管采血，用单向浸有酒精的棉签对左手无名指进行消毒一次。酒精自然变干后，用血柳叶刀刺穿左无名指的皮肤。
轻轻挤出第一滴血，用棉签擦拭。挤出足够的血液以形成一个完整的水滴，并使用定量移液管内的毛细管收集五微升的血液样品。对于试剂混合，将定量移液管插入溶血试剂中并紧按以将血液样品从毛细管中释放出来。
混合毛细管中的血液和溶血试剂，以恒定的速度将其倒置15至20次，直到毛细管中没有红血残留。通过打开盖子并将溶液挤入血细胞检测模块中来开始样品分析。接下来，按入口出口仓库按钮。
血细胞检测模块进入仓库后按下计数按钮。在分析仪界面上，单击"确定"按钮两次，确认血细胞检测模块已被取出。在分析仪界面上，单击打印按钮以打印测试结果。
要关闭分析器，请单击分析器界面上的关闭按钮，然后在界面上弹出的对话框中选择是。检查系统是否开始执行关机序列。将大型机背面的关闭或输入开关设置为关机序列完成后关闭。
该图显示了已评估系统和参考系统的散点图和斯皮尔曼相关分析。白细胞计数和粒细胞数表现出最强的相关性。然而，淋巴细胞数量在评估系统和参考系统之间表现出最弱的相关性。
获得布兰德-阿尔特曼图以可视化一致性分析。被评估系统检测到的白细胞结果与参考系统一致。白细胞指数差异的平均值高于零，表明评估系统的测试结果略高于参考系统的测试结果。
在实验过程中，我们应该尽力确保我们收集的血液保证正好是5微升，并且室内一侧被溶血试剂完全溶解。
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概述
本文介绍了一种使用POCT基于卡片的白细胞分析仪测量外周血白细胞的协议。该分析仪的准确性和一致性已通过与两台自动血液分析仪进行评估。
关键研究组成部分
科学领域
- 血液学
- 临床诊断
- 即时诊疗测试
背景
- 白细胞分析对于诊断各种医疗状况至关重要。
- 自动分析仪提供快速准确的结果。
- POCT设备提高了测试的可及性和便利性。
- 了解这些设备的操作对于获得可靠的结果至关重要。
研究目的
- 评估新白细胞分析仪的性能。
- 与已建立的自动血液分析仪比较结果。
- 提供使用分析仪的详细协议。
使用的方法
- 白细胞分析仪的标准操作。
- 血样收集和准备。
- 在新分析仪和参考分析仪上测试样本。
- 统计分析以评估相关性和准确性。
主要结果
- 新分析仪与参考系统显示出良好的相关性。
- 不同测试方法的结果一致。
- 操作效率被强调为一个关键优势。
- 用户友好的功能便于使用。
结论
- POCT白细胞分析仪是一种可靠的血液分析工具。
- 它在速度和易用性方面提供了显著优势。
- 建议在临床环境中进行进一步验证。
常见问题
Executive Industry Relevance
Point-of-care leukocyte analyzers address critical gaps in primary healthcare diagnostics by providing rapid, accurate white blood cell differentiation without requiring centralized laboratory infrastructure. This capability supports early infection triage and antimicrobial stewardship in resource-limited settings, directly impacting preclinical biomarker validation workflows where correlative hematological changes inform disease model relevance. The demonstrated correlation with reference hematology analyzers establishes predictive confidence for translational applications in inflammatory disease models.
Strategic Applications in Biopharma R&D
Early Discovery & Target Validation
- Scientific Value: Enables interrogation of leukocyte-mediated inflammatory pathways in disease models through quantifiable neutrophil, lymphocyte, and intermediate cell population shifts.
- Operational Value: Provides reproducible hematological readouts for target validation studies where immune cell infiltration serves as a pharmacodynamic biomarker.
Screening & Assay Development
- Scientific Value: Generates standardized leukocyte differential data essential for assay readiness screening of immunomodulatory compounds in whole blood systems.
- Operational Value: Eliminates liquid waste and complex sample preparation, enabling high-throughput screening compatibility with minimal technical expertise.
Translational & Preclinical Research
- Scientific Value: Supports disease-relevant system validation by correlating peripheral leukocyte dynamics with tissue-specific inflammatory endpoints in preclinical models.
- Operational Value: Facilitates longitudinal monitoring in preclinical studies through minimal blood volume requirements (5 µL capillary sampling) and rapid result generation.
Pipeline & Workflow Integration
The analyzer functions as a discovery-to-preclinical continuity tool, positioning leukocyte profiling between early target hypothesis testing and lead optimization phases where immune modulation represents a key mechanism of action.
- Discovery Biology: Supports mechanistic de-risking by quantifying immune cell responses to pathway modulators, reducing false positives in target validation cascades.
- Screening: Delivers quantitative, correlated leukocyte outputs (WBC, granulocytes, lymphocytes) that enable compound effect comparison across treatment groups.
- Analytics: Provides Spearman correlation-validated measurements (rs = 0.972 for WBC/granulocytes, rs = 0.851 for lymphocytes) ensuring reliable inter-system comparability for data-driven decision making.
- Translational Research: Connects discovery-phase leukocyte profiling to preclinical continuity through Bland-Altman-confirmed consistency with reference hematology systems.
- Enterprise Reuse: Represents a deployable capability across multiple therapeutic areas requiring immune monitoring, reducing redundant validation efforts.
Operational & Enterprise Impact
- Scientific Value: Predictive confidence in leukocyte-mediated mechanism of action, reduction of mechanistic ambiguity in immunomodulator screening.
- Operational Value: Standardization through maintenance-free operation, reproducibility via 95% limits of agreement, and scalability through single-person detection kits.
- Strategic Value: Better go/no-go decisions in immunomodulator programs, capital efficiency by avoiding core lab dependencies, and reduced late-stage biological risk through early immune profiling.
- Portfolio Impact: Risk-adjusted prioritization of compounds based on leukocyte response profiles, enabling advancement decisions grounded in translatable hematological biomarkers.
Implementation Considerations
- Requires basic hematology knowledge for accurate interpretation of leukocyte differentials (neutrophils, lymphocytes, intermediate cells).
- Needs capillary blood collection training and quantitative pipette proficiency for precise 5 µL sample volume.
- Demands cross-team standardization of reference group selection (age/gender-adjusted norms) for consistent longitudinal tracking.
- Requires adaptation validation when extending beyond human whole blood to preclinical model systems (e.g., murine, non-human primate).
- Practical limitation: Lower lymphocyte correlation (rs = 0.851) necessitates orthogonal validation for lymphocytic-focused immunotherapies.
