A sandwich ELISA for the quantification of the anticancer peptide CIGB-552 in human plasma

IF 2.6 4区生物学 Q2 BIOCHEMICAL RESEARCH METHODS

Analytical biochemistry Pub Date : 2024-11-27 DOI:10.1016/j.ab.2024.115725

Nivaldo Angel Gómez Hernández , Gilda Lemos Pérez , Amalia Vazquez Arteaga , Hilda Elisa Garay Pérez , Brizaida Oliva Arguellez , Ania Cabrales Rico , Airela Llamo Guardia , Julio Raúl Fernández Massó

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引用次数: 0

Abstract

CIGB-552 is a synthetic anticancer peptide that has been evaluated in vitro and in vivo in lung and colon cancer models. To optimize therapy in the clinic, pharmacokinetic studies are necessary. Previously, a sandwich-type enzyme-linked immunosorbent assay (ELISA) had been developed by our working group for the quantification of CIGB-552 in biological matrices. The objective of this work was to carry out the full validation of the ELISA to support its application in clinical trials. First, we obtained a polyclonal antibody specific for CIGB-552 and with purity greater than 95 %. The lower limit of quantification and the upper limit of quantification were 3125 ng/ml and 200 ng/ml, respectively. The method is exact and precise in the quantification of the peptide with relative error and coefficient of variation values less than 20 %. The ELISA is specific in the presence of CIGB-552 metabolites in the sample, and also presents robustness to certain protocol variations. In summary, the validated ELISA meets the requirements for its application in upcoming clinical trials as part of pharmacokinetic studies.

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夹心ELISA法定量测定人血浆中抗癌肽CIGB-552。

CIGB-552是一种合成的抗癌肽，已在体外和体内对肺癌和结肠癌模型进行了评估。为了优化临床治疗，药代动力学研究是必要的。以前，我们的工作组开发了一种三明治型酶联免疫吸附测定法（ELISA），用于定量生物基质中的CIGB-552。这项工作的目的是对ELISA进行全面验证，以支持其在临床试验中的应用。首先，我们获得了一种纯度大于95%的CIGB-552特异性多克隆抗体。定量下限为3125 ng/ml，定量上限为200 ng/ml。该方法定量准确，相对误差和变异系数值均小于20%。ELISA对样品中存在CIGB-552代谢物具有特异性，并且对某些方案变化具有稳健性。综上所述，经验证的ELISA符合其在即将进行的临床试验中作为药代动力学研究的一部分应用的要求。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Analytical biochemistry 生物-分析化学

CiteScore

5.70

自引率

0.00%

发文量

283

审稿时长

44 days

期刊介绍： The journal''s title Analytical Biochemistry: Methods in the Biological Sciences declares its broad scope: methods for the basic biological sciences that include biochemistry, molecular genetics, cell biology, proteomics, immunology, bioinformatics and wherever the frontiers of research take the field. The emphasis is on methods from the strictly analytical to the more preparative that would include novel approaches to protein purification as well as improvements in cell and organ culture. The actual techniques are equally inclusive ranging from aptamers to zymology. The journal has been particularly active in: -Analytical techniques for biological molecules- Aptamer selection and utilization- Biosensors- Chromatography- Cloning, sequencing and mutagenesis- Electrochemical methods- Electrophoresis- Enzyme characterization methods- Immunological approaches- Mass spectrometry of proteins and nucleic acids- Metabolomics- Nano level techniques- Optical spectroscopy in all its forms. The journal is reluctant to include most drug and strictly clinical studies as there are more suitable publication platforms for these types of papers.