Name: evaluation of a point-of-care testing analyzer for measuring peripheral blood leukocytes
Uploaded: 2022-03-22T15:00:00
Description: Watch this Scientific Journal Video about Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes at JoVE.com

本研究由中国广东省医学科学研究基金会（A2019224）资助。资助小组同意研究设计，数据分析，手稿准备和出版决定。这项研究没有收到其他资金。

本研究及人体血液样本的使用经广州医科大学第一附属医院伦理委员会批准（GYYY-2016-73）。所有参与者均已独立或通过其父母（对于儿童）给予书面同意。
1. 研究组基本信息
注：从曾就诊广州医科大学第一附属医院（第1医院）和遵义医科大学第五附属（珠海）医院（第2医院）的患者采集静脉血。医院1中用于血液常规检查的仪器是参考系统1?...

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随着现代实验室医学的进步，现在通常可以看到在相同或不同实验室中使用几种检测技术来鉴定相同的临床标志物。因此，应更加重视检测结果的一致性，以协助诊所对检测结果做出准确的解释和判断。调查显示，三级医院和独立实验室的实验室设备总值远高于基层医院和其他医疗机构4。这类设备虽然具有项目检测多、精度高、稳定性好、检测通量大等优点，但存在价格昂贵、...

白细胞（WBC）计数或分类是反映机体炎症的重要指标，可区分细菌感染和病毒感染。白细胞分析也有助于指导后续诊疗1.目前，五级全自动血液分析仪由于自动化程度高，效率高，产生准确可靠的结果，有效地降低了实验室技术人员的工作强度，因此已广泛应用于大中型医疗单位。它在临床检查中起重要作用2，3。然而，大多数初级医疗机构，如社区保健中心和私人诊所，血液学分析仪的采用率较低。根据一项关于我国临床实验室建设的全国性多中心研究，基层医疗机构的实验室建设不足，实验室规模小、人才输送不足、科技向农村推广等因素4证明了这一点。
自2019年12月以来，COVID-19开始在世界各地蔓延，并发展成为全球大流行。在“后疫情时代”，提出了一系列国家政策，以实施疫情常态化的防控措施。基层医疗机构实验室在基层诊疗和疾病防控中发挥着重要作用。它是疫情中的第一道防线和控制线，对COVID-19预防和控制至关重要5。一些研究表明，外周血淋巴细胞和中性粒细胞的检测将有助于COVID-19患者的筛查、诊断和治疗，中性粒细胞/淋巴细胞比值也可以作为重症和危重COVID-19的临床预警指标6，7。此外，白细胞检测具有提供快速报告的好处。基层医疗卫生机构可以广泛开展白细胞检测，帮助及时发现和筛查疑似感染。
基于POCT卡的白细胞分析仪（评估系统;见 材料表）是基于黄金标准“库尔特原理”的三级血细胞分析仪。评估的系统提供一个WBC直方图和七个血液参数的定量分析结果，包括WBC计数，粒细胞数（Gran#），粒细胞百分比（Gran%），淋巴细胞数（Lym#），淋巴细胞百分比（Lym%），中间细胞数（Mid#）和中间细胞百分比（Mid%）。它采用基于卡的创新技术，具有单人检测套件可用，无液体浪费，30秒检测速度快，无需日常维护，操作人性化等优点。因此，它特别适合初级医疗机构。本研究旨在通过与两家大型公立医院实验室的两台全自动商用血液分析仪（参考系统1和参考系统2;见 材料表）进行比较，评估POCT卡式白细胞分析仪的临床检测性能。

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>Blood cell detection module</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>Blood lancet</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>Hemolytic reagent</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>IBM SPSS Statistics 25</td>
			<td>International Business Machines Corp., Armonk, NY</td>
			<td></td>
			<td>Software for data analysis</td>
		</tr>
		<tr>
			<td>MedCalc 11.4.2.0</td>
			<td>2021 MedCalc Software Ltd</td>
			<td></td>
			<td>Software for data analysis</td>
		</tr>
		<tr>
			<td>Microsoft Excel 2019</td>
			<td>Microsoft</td>
			<td></td>
			<td>Software for data analysis</td>
		</tr>
		<tr>
			<td>Point-of-care testing (POCT) card-based leukocyte analyzer</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td>CX-2000</td>
			<td>Evaluated system</td>
		</tr>
		<tr>
			<td>Quantitative pipette with capillary tube inside</td>
			<td>Chuanghuai Medical Technology Co., Ltd.(Shenzhen, China)</td>
			<td></td>
			<td>consumables for evaluated system</td>
		</tr>
		<tr>
			<td>Siemens fully automatic hematology analyzer and its related reagents and consumables</td>
			<td>Siemens Healthcare Diagnostics Inc.</td>
			<td>ADVIA 2120i</td>
			<td>Reference system 2</td>
		</tr>
		<tr>
			<td>UniCel DxH 800 Coulter Cellular Analysis System and its related reagents and consumables</td>
			<td>Beckman Coulter, Inc.</td>
			<td>DxH 800</td>
			<td>Reference system 1</td>
		</tr>
	</tbody>
</table>

evaluation of a point-of-care testing analyzer for measuring peripheral blood leukocytes

白细胞（WBC）是体内炎症的重要指标，它可以帮助区分细菌和病毒感染。目前，我国大多数基层医疗机构采用血液检测技术的比例较低，基层医疗中心迫切需要一套性价比高、操作简便的血液学检测系统。本文介绍了基于床旁检测（POCT）卡的白细胞分析仪（评估系统）的原理和操作程序，该分析仪用于检测全血中的中性粒细胞，淋巴细胞和中间组细胞（包括嗜酸性粒细胞，嗜碱性粒细胞和单核细胞）等WBC指标。将评估系统的结果与两台商用自动血液分析仪（参考系统）的结果进行比较。分析了评价体系与商业参考体系的相关性和一致性。结果显示，被评价和参比系统检测到的WBC计数和粒细胞数量呈强正相关（rs = 0.972和0.973），而淋巴细胞数量表现出相对较低的相关性（rs = 0.851）。Bland-Altman图表明，评估系统与参考系统检测到的值之间的主要差异在95%的一致性限（LoA）内，表明两个系统具有良好的一致性。总之，该评估系统具有出色的相关性，稳健的一致性，并与广泛使用的自动血液分析仪的结果进行了可靠的比较。它是没有全自动五类血液学分析仪的基层医疗机构进行WBC检测的理想选择，特别是在COVID-19正常化预防和控制期间。

示例数据 共有1066名患者在两个研究中心入组，包括医院1（n = 532）和医院2（n = 534）。患者特征示于 表1中。男性比例为49.9%，中位年龄为52岁（32岁，66岁）。参加研究的患者包括住院患者（51.1%），门诊患者（39.0%）和体格检查患者（8.4%）。测试样本来自到内科（30.6%）、外科（19.1%）、妇产科（9.0%）、儿科（3.9%）等。
检测异常结果（异常?...

Watch this Scientific Journal Video about Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes at JoVE.com

Evaluation of a Point-of-Care Testing Analyzer for Measuring Peripheral Blood Leukocytes

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。

用于测量外周血白细胞的床旁测试分析仪的评估

White blood cell (WBC) is an important indicator of inflammation in the body, and it can help distinguish between bacterial and viral infections. At ...

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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Acute lower extremity deep venous thrombosis (DVT) is a serious vascular disorder that requires accurate and early diagnosis to prevent life-threatening ...

Point-of-Care Lung Ultrasound in Adults: Image Acquisition

成人床旁肺部超声：图像采集

Consultative ultrasound performed by radiologists has traditionally not been used for imaging the lungs, as the lungs&#39; air-filled nature normally ...

Point-of-Care Ultrasound: A Review of Ultrasound Parameters for Predicting Difficult Airways

床旁超声：预测困难气道的超声参数综述

Airway management remains a crucial part of perioperative care. The conventional approach to assessing potentially difficult airways emphasizes the LEMON ...

Imaging the Abdominal Aorta with Point-of-Care Ultrasound

An Approach to Point-Of-Care Ultrasound Evaluation of the Abdominal Aorta

Author Spotlight: Using Point-of-Care Ultrasound for Comprehensive Evaluation of the Abdominal Aorta

腹主动脉床旁超声评估方法

Disorders of the abdominal aorta, including aneurysms and dissection, have potentially high rates of morbidity and mortality. While computed tomography ...

Gastric Ultrasound Technique for Mitigating Peri-Procedural Aspiration Risk

Gastric Point of Care Ultrasound in Adults: Image Acquisition and Interpretation

Point-of-Care Ultrasound for Gastric Content Assessment and Risk Stratification in Perioperative Care (Video) | JoVE

成人胃旁超声：图像采集和解释

Over the past two decades, diagnostic point-of-care ultrasound (POCUS) has emerged as a rapid and non-invasive bedside tool for addressing clinical ...