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《医学实验室真空采血管性能评估专家共识》在沪正式发布,助力我国实验室检验质量迈上新台阶

2022-09-17 中华医学会检验医学分会 中华医学会检验医学分会

该共识旨在为医学实验室提供真空采血管性能评估标准和技术细则,进一步提升我国实验室检验质量,具备权威性、全面性、可操作性和深入性的特点。

2022917日,《医学实验室真空采血管性能评估专家共识》(以下简称:《共识》)在上海正式发布,中华医学会检验医学分会主委及多位检验医学专家共同参与了本次共识发布。该《共识》由中华医学会检验医学分会起草,今年4月发表于《中华检验医学杂志》,涵盖了真空采血管性能评估的必要性、评估原则、评估内容和评估方法等内容,旨在为医学实验室提供真空采血管性能评估标准和技术细则,进一步提升我国实验室检验质量,具备权威性、全面性、可操作性和深入性的特点。该《共识》的出台,得到了全球领先的医疗技术公司碧迪医疗的支持。

随着我国检验医学三十年来的高速发展,检验人员对各环节的质量把控要求已经变得更精准、更深入、更严谨。而真空采血管作为临床上最广泛使用的分析设备,对其性能评估的专业化和标准化,对整个行业具有标志性的示范意义。中华医学会检验医学分会副主任委员表示,我国现有真空采血管推荐标准与国际指南共识相比,在完备性和可操作性上尚有一定的差距。在此背景下,《共识》应运而生,致力于与国际标准接轨的同时兼顾中国检验科学的独特要求、为临床提供操作性强的标准化指南,从而提升中国实验室对采血管质量的把控能力,取得更加高质量的检验结果。

真空采血管是一种用于血液样品采集和盛装的无菌器皿,看似简单,实际包括多个不同材质的组件,原材料品种多,生产工艺复杂。真空采血管质量带来的分析前问题较为普遍,是分析前误差的重要原因。有数据显示,分析前误差大约占医学检验总误差的70%1,而在分析前误差中,大约80%是样本采集的质量问题2,分析前误差造成的医院年费用可高达¥6,867,973,从而引起的进一步不适宜检查增加的费用则需要¥2,663,6753。然而,在临床工作中查找误差原因时,真空采血管质量往往是最易被忽视的因素,因此唯有从源头保证真空采血管质量,才能减少或杜绝医疗风险。

此次《共识》的出台,充分结合了国际先进经验和我国临床的实际情况,从质量性能评估和临床性能评估两大方面,制定了详尽的评估标准和方法。

首先,质量性能评估的目的在于确认真空采血管本身质量是否符合临床要求。如外观方面,要求标签内容正确完整,与所贴产品规格相符,必须包含无菌标识,应选择合适的灭菌方式(推荐伽马射线灭菌);材质方面,不应添加磷酸三丁氧基乙基酯(增塑剂TBEP)以增加胶塞的硬度、增加胶塞的弹性;抽吸体积一致性方面,要求抽吸量与公称液体容量的相对偏倚应在-10%10%之间,同时抽吸体积的变异系数(CV≤10%等。

其次,临床性能评估是评价真空采血管的分析性能,从测量误差的角度判断试验管能否替代对照管进入临床使用,包括一致性和精密度两个方面。一致性评估是判断试验管和对照管的检测结果偏差是否在所允许的范围内。精密度评估是判断试验管和对照管的结果可重复性是否有明显差异。

此外,《共识》也详细规定了真空采血管医学实验室性能评估的适用场合,包括更换新的真空采血管品牌时;更换真空采血管产品批号时;对正在使用的真空采血管的检测结果有疑问、查找原因可能与真空采血管相关时;实验室根据使用情况定期对真空采血管进行评估时。通过适时的真空采血管评估,将有助于避免结果错误带来的患者误诊误治,减少复测带来的医学实验室人力、物力损失等。

碧迪医疗大中华区整合诊断解决方案业务副总裁刘士强先生表示:非常荣幸能够支持并见证《共识》的发布,助力中国医学实验室检验质量迈上新的台阶。作为全球领先的医疗技术公司,IDS整合诊断解决方案业务部门秉承以客户为中心的宗旨,提供从样本采集到快速准确的病原微生物检测报告,学术支持及专业教育等整体解决方案,帮助检验人员简化流程、提升效率、持续不断地提升检验结果准确性,改善患者预后。

作为真空采血管的发明者,碧迪医疗不仅通过不断改进产品来提高样本的完整性、给予医护人员更多防护,更一直致力于跟学会和临床专家一起提升行业标准和规范。此次《共识》是继2020年支持中华医学会检验分会发布《不合格静脉血标本管理中国专家共识》后的又一例证。此外,碧迪医疗还是AACC在中国的独家合作伙伴,长期推动国内临床教育,让医学检验人员在家门口就能学习到全球学术前沿研究和临床应用进展。碧迪医疗与CAP也达成了长期战略合作,是CAP在国内唯一合作伙伴,为实验室认证提供专业服务。未来,我们将一如既往支持中国医学实验室标准和样本质量管理的提升。

参考资料:

1. Hammerling J A. A review of medical errors in laboratory diagnostics and where we are today[J]. Laboratory medicine, 2012, 43(2): 41-44.

2. 敬华,.总装备部医学学报,2010,12(04):221-223.

3. Plebani M, Carraro P. Mistakes in a stat laboratory: types and frequency[J]. Clinical Chemistry, 1997, 43(8): 1348-1351.

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    2023-04-21 ms9000000421332414 来自广东省

    这个共识在哪里可以下载

    0

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  5. [GetPortalCommentsPageByObjectIdResponse(id=1845970, encodeId=a9a318459e0ec, content=<a href='/topic/show?id=5d2f206482e' target=_blank style='color:#2F92EE;'>#专家共识#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=20648, encryptionId=5d2f206482e, topicName=专家共识)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=568152, createdName=snowpeakxu, createdTime=Mon Apr 10 12:30:07 CST 2023, time=2023-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1988548, encodeId=cb8d198854836, content=<a href='/topic/show?id=9bde52e0831' target=_blank style='color:#2F92EE;'>#性能评估#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52708, encryptionId=9bde52e0831, topicName=性能评估)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=02f5179, createdName=luoxiaog, createdTime=Sat Apr 01 14:30:07 CST 2023, time=2023-04-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2127451, encodeId=f44e212e45162, content=这个共识在哪里可以下载, beContent=null, objectType=article, channel=null, level=null, likeNumber=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=59676392558, createdName=ms9000000421332414, createdTime=Fri Apr 21 11:35:14 CST 2023, time=2023-04-21, status=1, ipAttribution=广东省), GetPortalCommentsPageByObjectIdResponse(id=1812401, encodeId=30881812401ef, content=<a href='/topic/show?id=9ff9896405e' target=_blank style='color:#2F92EE;'>#血管性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=89640, encryptionId=9ff9896405e, topicName=血管性)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=仁心济世, createdTime=Wed Oct 26 06:30:07 CST 2022, time=2022-10-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1362067, encodeId=5203136206e7a, content=<a href='/topic/show?id=b3d195659ce' target=_blank style='color:#2F92EE;'>#采血#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=95659, encryptionId=b3d195659ce, topicName=采血)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6c3a189, createdName=longqijun248, createdTime=Mon Sep 19 00:30:07 CST 2022, time=2022-09-19, status=1, ipAttribution=)]
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