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CLIN CHEM LAB MED：在Atellica化学和免疫分析分析仪上进行20项分析的多站点性能评估和Sigma指标如何？

2020-02-12 MedSci MedSci原创

Sigma指标Atellica
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Atellica溶液包括化学(CH)和免疫测定(IM)分析仪。最近，欧洲6个早期采用的临床实验室评估了20项CH和IM测定的分析性能。为了测量分析性能质量，计算了单个站点和联合站点结果的Sigma指标。

Atellica溶液包括化学(CH)和免疫测定(IM)分析仪。最近，欧洲6个早期采用的临床实验室评估了20项CH和IM测定的分析性能。为了测量分析性能质量，计算了单个站点和联合站点结果的Sigma指标。

按照美国临床实验室标准协会(Clinical Laboratory Standards Institute)的协议进行精度、检测能力、线性度和方法比较研究。根据医疗决策级别的汇总数据计算跨站点的全局Sigma指标，根据医学决策水平的汇总数据计算出各个站点的全球Sigma指标：Sigma metrics=%TEa–%bias/%CV. 通过结合从各个站点获得的不精确性，计算了合并的%CV。使用Deming回归分析(对于电解质的pass - bablok回归)，对ADVIA化学系统或ADVIA Centaur系统对场地数据进行偏差计算。103个个位Sigma的计算采用了个位不精确和汇总偏倚。

研究结果显示空白的界限和检测结果符合厂家的要求。大多数检测方法在检测范围内都是线性的。合并的西格玛指标良好或更好(>4西格玛)的20个检测中的18个；尿素氮(3.1)和钠(3.9)均可接受，但后者的数值在五个位点中有一个不精确。

在评估Atellica解决方案的多个实际站点中生成的数据的Sigma指标显示，对于20个测试中的18个，其良好或较好的性能高于4 Sigma。总的来说，结果证实了制造商的声明，方法适合在临床实验室使用。

原始出处：

Tommaso Fasano,Jose Luis Bedini,Multi-site performance evaluation and Sigma metrics of 20 assays on the Atellica chemistry and immunoassay analyzers

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    2021-01-16 luoxiaog

    #性能评估#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1988547, encodeId=b77c198854e4d, 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=34, 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 Jan 16 20:02:00 CST 2021, time=2021-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1700380, encodeId=1dad1e0038065, content=<a href='/topic/show?id=a40c9525be' target=_blank style='color:#2F92EE;'>#IgM#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9525, encryptionId=a40c9525be, topicName=IgM)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e80a30065003, createdName=yhy100210, createdTime=Mon Sep 21 13:02:00 CST 2020, time=2020-09-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1928168, encodeId=825f1928168c2, content=<a href='/topic/show?id=c56d2896643' target=_blank style='color:#2F92EE;'>#免疫分析#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=28966, encryptionId=c56d2896643, topicName=免疫分析)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e0a1165, createdName=jiangfeng5067, createdTime=Fri Nov 20 13:02:00 CST 2020, time=2020-11-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2058258, encodeId=a5952058258ac, content=<a href='/topic/show?id=d4cf293132' target=_blank style='color:#2F92EE;'>#Atellica#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2931, encryptionId=d4cf293132, topicName=Atellica)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ca20190, createdName=wushaoling, createdTime=Wed May 20 19:02:00 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1610237, encodeId=58de161023ed9, content=<a href='/topic/show?id=eb6b1145939' target=_blank style='color:#2F92EE;'>#Med#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11459, encryptionId=eb6b1145939, topicName=Med)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=552a19396740, createdName=ms3994565386320060, createdTime=Fri Feb 14 14:02:00 CST 2020, time=2020-02-14, status=1, ipAttribution=)]
    2020-09-21 yhy100210

    #IgM#

    0

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    2020-11-20 jiangfeng5067

    #免疫分析#

    0

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    2020-05-20 wushaoling

    #Atellica#

    0

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    2020-02-14 ms3994565386320060

    #Med#

    0