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胰岛素:了解您的免疫测定法检测的内容。两种新免疫测定法的评估。

Insulin: Know what your immunoassay detects. Evaluation of two new immunoassays.

机构信息

Nantes Université, CHU Nantes, Department of Biology, Laboratory of Biochemistry, F-44000 Nantes, France.

Nantes Université, CHU Nantes, Department of Biology, Laboratory of Biochemistry, F-44000 Nantes, France.

出版信息

Clin Chim Acta. 2023 Aug 1;548:117516. doi: 10.1016/j.cca.2023.117516. Epub 2023 Aug 19.

DOI:10.1016/j.cca.2023.117516
PMID:37598742
Abstract

BACKGROUND

Insulin is essential for glycemic regulation but diseases can cause a default or an excess of insulin secretion leading to dysregulated glycemia. Hence, measurement of insulinemia is useful to investigate hypoglycemia, determine the pathogenesis of diabetes and evaluate β-cell function. Thus, diabetic patients need supplementation with recombinant human insulin and/or insulin analogues. Analogues have primary sequences different from native human insulin and may not be detected by some immunoassays. The objective of our study was to evaluate new insulin immunoassays by determining their ability to detect different types of human insulin or analogues.

METHODS

This study compared the reactivity of two new insulin immunoassays with five well-established immunoassays on ten commercial insulins. We also measured insulin in blood samples from diabetic or pancreas transplant patients with known treatment.

RESULTS

Contrary to recombinant human insulin, there were differences in the specificity to insulin analogues. We distinguished three immunoassay categories: those recognizing all types of insulin such as the non-specific BI-INS-IRMA®, Architect® and Access® immunoassays; those recognizing human insulin only (Cobas®); and those recognizing human insulin and analogues in variable proportions (Liaison XL®, iFlash® and Maglumi®).

CONCLUSION

An accurate biological interpretation of insulinemia relies on knowledge of the specificity of the immunoassay used.

摘要

背景

胰岛素对于血糖调节至关重要,但疾病可能导致胰岛素分泌不足或过多,从而导致血糖失调。因此,测量胰岛素血症对于研究低血糖、确定糖尿病的发病机制和评估β细胞功能非常有用。因此,糖尿病患者需要补充重组人胰岛素和/或胰岛素类似物。类似物的一级序列与天然人胰岛素不同,可能无法被某些免疫测定法检测到。我们的研究目的是评估新的胰岛素免疫测定法,通过确定它们检测不同类型的人胰岛素或类似物的能力。

方法

本研究比较了两种新的胰岛素免疫测定法与五种成熟的免疫测定法在十种商业胰岛素上的反应性。我们还测量了已知治疗的糖尿病或胰腺移植患者的血液样本中的胰岛素。

结果

与重组人胰岛素不同,胰岛素类似物的特异性存在差异。我们将免疫测定法分为三类:识别所有类型胰岛素的非特异性 BI-INS-IRMA®、Architect®和 Access®免疫测定法;仅识别人胰岛素的 Cobas®;以及以不同比例识别人胰岛素和类似物的 Liaison XL®、iFlash®和 Maglumi®。

结论

准确的胰岛素生物学解释依赖于所用免疫测定法的特异性知识。

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