Clin Chem:11种血清IgA检测系统检测间一致性的真实性评价与验证

2019-07-20 不详 MedSci原创

在临床研究中,要确定<span lang="EN-US" style="font-size:12.0pt;mso-bidi-font-size:14.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;; mso-fareast-font-family:宋体;mso-bidi-font-family:&quot;Times New

临床研究中,要确定IgA缺陷,必须提供可靠的IgA较低参考值,特别是在儿科。在本研究中,研究人员报告了一项相互比较研究的结果,该研究旨在使用11个商用测量系统(MSs)验证IgA测量的标准化状态。

研究人员采用ERM-DA470k/IFCC标准品对IgA MSs的真确性进行评价。此外,使用18个患者验证了检测间的一致性。将所得的ERM-DA470k/IFCC的均值与其目标值之间的偏差(如果有的话)MSs的平均不精确性与各自校准器的不确定性相结合,估算了IgA测量在临床样本上的平均不确定性(U)

研究发现,虽然大部分IgA MSs之间一致性较高,但对ERM-DA470k/IFCC目标值的偏差在55%的病例中是不可接受的。这种偏差导致临床样本中IgAU值过高。重要的是,当分析集中在低IgA浓度(典型的儿童)时,情况会恶化,只有4MSs表现出良好的等效性。

研究表明,虽然市面上大多数商用IgA MSs之间的一致性较好,但对高级参比的可追溯性的实施仍不充分,尤其是在浓度≤0.7g/ L时。在儿科人群中定义可跟踪参考区间时,需要对这一分析背景信息仔细考虑。

原始出处:

Federica Braga, Ilenia Infusino,Trueness Evaluation and Verification of Interassay Agreement of 11 Serum IgA Measuring Systems: Implications for Medical Decisions

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    2020-03-15 zhanfl
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    2019-07-22 huagfeg
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    2019-07-22 yibei