Diagnostic methods for the measurement of human TNF-alpha in clinical laboratory
Diagnostic methods for the measurement of human TNF-alpha in clinical laboratory
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DOI：
10.1016/j.jpba.2019.113010
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发表时间：
2020-02-03
影响因子：
3.4
通讯作者：
Probst-Muller, Elisabeth
中科院分区：
文献类型：
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作者：
Valaperti, Alan;Li, Zhe;Probst-Muller, Elisabeth
检测外周血中肿瘤坏死因子-α(TNF-α)是评估多种疾病炎症反应的有用工具。细胞因子分析的主要挑战之一是获得具有高特异性、准确性、线性、精密度、稳定性和分析灵敏度的适当分析工具。虽然现有的免疫分析方法通常是可靠的和可重复性的，但它们也是不可互换的。比较了两种ELISA法、四种流式细胞仪微珠阵列(CBA)和四种Luminex免疫分析方法。不同技术之间几乎没有相关性，而基于同一技术的一些免疫分析显示出显著的相关性。在评估的10种不同的化验中，只有少数几种化验符合预先设定的验收验证标准。有趣的是，来自同一健康捐献者的血清和血浆具有显著不同的参考值。样品在血清中的稳定性在四度下保持长达一周，而血浆只有在冷冻时才稳定。由于几种抗炎治疗是基于针对肿瘤坏死因子-α(抗肿瘤坏死因子-α抗体)的生物制剂，因此对免疫测定的潜在干扰进行了测试，结果是相关的。这项研究表明，尽管每种免疫测定都有优点和缺点，但很少有分析方法适用于临床实验室中的肿瘤坏死因子-α的测定，这表明，到目前为止，人体血液中的肿瘤坏死因子-α的测定仍然没有统一。此外，我们发现，抗肿瘤坏死因子-α治疗引起的假阴性结果在结果解释时应仔细考虑。(C)2019爱思唯尔B.V.保留所有权利。
Measurement of Tumour Necrosis Factor alpha (TNF-alpha) in peripheral blood is a useful tool to assess inflammatory responses in a large range of diseases. One of the major challenges for cytokine analysis is the availability of a proper analytical tool with high specificity, accuracy, linearity, precision, stability, and analytical sensitivity. Although available immunoassays are usually robust and reproducible, it is also true that they are not interchangeable.Two ELISA, four flow cytometric bead array (CBA) and four Luminex immunoassays were compared. Correlation between different techniques was almost absent, while some immunoassays based on the same technique showed significant correlation. Among the ten different assays evaluated, just few of them complied with the pre-established acceptance validation criteria. Interestingly, sera and plasma collected from the same healthy donor had significant different reference values. Samples stability was maintained in serum up to one week at four degrees, while plasma was stable only when it was frozen. Since several anti-inflammatory treatments are based on biologics targeting TNF-alpha (anti-TNF-alpha antibodies), potential interference with the immunoassays was tested and resulted relevant.This study shows that although each immunoassay presents benefits and drawbacks, just few assays are suitable for the measurement of TNF-alpha in clinical laboratories, demonstrating that, so far, the measurement of TNF-alpha in human blood is still not yet harmonised. In addition, we found that false negative results caused by anti-TNF-alpha treatments should be carefully considered for results interpretation. (C) 2019 Elsevier B.V. All rights reserved.