Clin Chem Lab Med. 2014 Mar;52(3):355-62. doi: 10.1515/cclm-2013-0427.
Over the last few decades, new synthetic insulin analogues have been developed. Their measurement is of prime importance in the investigation of hypoglycaemia, but their quantification is hampered by variable cross-reactivity with many insulin assays. For clinical analysis, it has now become essential to know the potential cross-reactivity of analogues of interest.
In this work, we performed an extensive study of insulin analogue cross-reactivity using numerous human insulin immunoassays. We investigated the cross-reactivity of five analogues (lispro, aspart, glulisine, glargine, detemir) and two glargine metabolites (M1 and M2) with 16 commercial human insulin immunoassays as a function of concentration.
The cross-reactivity values for insulin analogues or glargine metabolites ranged from 0% to 264%. Four assays were more specific to human insulin, resulting in negligible cross-reactivity with the analogues. However, none of the 16 assays was completely free of cross-reactivity with analogues or metabolites. The results show that analogue cross-reactivity, which varies to a large degree, is far from negligible, and should not be overlooked in clinical investigations.
This study has established the cross-reactivity of five insulin analogues and two glargine metabolites using 16 immunoassays to facilitate the choice of the immunoassay(s) and to provide sensitive and specific analyses in clinical routine or investigation.
在过去的几十年中，已经开发出了新的合成胰岛素类似物。它们的测量对于低血糖的研究至关重要，但由于许多胰岛素检测方法的交叉反应性不同，因此它们的定量受到了阻碍。对于临床分析，现在必须了解感兴趣的类似物的潜在交叉反应性。
在这项工作中，我们使用许多人胰岛素免疫测定法对胰岛素类似物的交叉反应性进行了广泛的研究。我们研究了五种类似物（赖脯胰岛素、门冬胰岛素、谷赖胰岛素、甘精胰岛素、地特胰岛素）和两种甘精胰岛素代谢物（M1 和 M2）与人胰岛素免疫测定法的交叉反应性作为浓度的函数。
胰岛素类似物或甘精胰岛素代谢物的交叉反应性值范围为 0%至 264%。有四种检测方法对人胰岛素更具特异性，导致与类似物的交叉反应性可忽略不计。但是，没有一种 16 种检测方法完全没有与人胰岛素类似物或代谢物的交叉反应性。结果表明，类似物的交叉反应性差异很大，绝不能忽视，在临床研究中应加以注意。
本研究使用 16 种免疫测定法确定了五种胰岛素类似物和两种甘精胰岛素代谢物的交叉反应性，以方便免疫测定法的选择，并在临床常规或研究中提供敏感和特异性分析。
