Production of antibody and development of enzyme-linked immunosorbent assay for therapeutic drug monitoring of eravacycline.

Autor: Galvidis IA; I. Mechnikov Research Institute for Vaccines and Sera, Moscow 105064, Russia., Moshcheva AG; I. Mechnikov Research Institute for Vaccines and Sera, Moscow 105064, Russia., Surovoy YA; University College of London Hospital, London NW1 2BU, United Kingdom., Sobolev PD; Exacte Labs LLC, Moscow 117246, Russia., Sharipov VR; I. Mechnikov Research Institute for Vaccines and Sera, Moscow 105064, Russia; Exacte Labs LLC, Moscow 117246, Russia., Sidorov NG; I. Mechnikov Research Institute for Vaccines and Sera, Moscow 105064, Russia., Tsarenko SV; Faculty of Medicine, M.V. Lomonosov Moscow State University, Moscow 119991, Russia., Burkin MA; I. Mechnikov Research Institute for Vaccines and Sera, Moscow 105064, Russia. Electronic address: burma68@yandex.ru.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 May 15; Vol. 242, pp. 116033. Date of Electronic Publication: 2024 Feb 13.
DOI: 10.1016/j.jpba.2024.116033
Abstrakt: Eravacycline (ERC) was approved for clinical use in 2018. It is more potent than other tetracyclines and can overcome resistance, making it an attractive option for combating multidrug-resistant bacterial infections. Intensive pharmacokinetic (PK) studies are currently being conducted to ensure the effectiveness and safety of ERC in various groups of patients, including those undergoing extracorporeal therapies. This study is the first attempt to develop a simple, efficient, and high-throughput immunoassay for quantifying ERC in human or animal serum. BSA-ERC conjugate as immunogen elicited antibody production in rabbits. Monitoring of the immune response and comparison of homologous and heterologous coating antigens allowed selection of immunoreagents and development of an assay that was selective for ERC possessing sensitivity (IC 50 ), dynamic range (IC 20 -IC 80 ) and detection limit equal to 3.3 ng/mL, 0.27-54 ng/mL and 0.09 ng/mL, respectively. The developed ELISA showed acceptable recovery of ERC (85-105 %) from rabbit and human serum in the clinically relevant concentration range of 0.1-3.0 mg/L. The method was used to quantify serum ERC concentration in the pilot PK study in Soviet chinchilla rabbits. The results were confirmed by HPLC-MS/MS.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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