Development of a monoclonal antibody-based immunochromatographic strip for the rapid detection of tigecycline in human serum

Abstract

In this study, a gold labelled immunochromatographic assay was developed to detect tigecycline (TGC) in human serum. For this purpose, an anti-TGC monoclonal antibody, 2G7, was produced and characterized, and was found to have a 50%-inhibitory concentration (IC₅₀) of 2.303 ng mL⁻¹ and a limit of detection (LOD) of 0.215 ng mL⁻¹ for TGC. This strip assay had a visual limit of detection (vLOD) of 50 ng mL⁻¹ and a cut-off value of 1000 ng mL⁻¹ for TGC in human serum, when assessed by eye. With the aid of a strip scan reader, a quantitative determination of TGC was obtained with a calculated limit of detection (cLOD) of 15.03 ng mL⁻¹. Analysis of TGC in human serum indicated that the results of our strip assay compared well with results obtained using ic-ELISA and LC-MS/MS. Therefore, this strip assay represents a sensitive and reliable method for the on-site detection of TGC in serum samples.