The Evaluation of a Lateral Flow Strip Based on the Covalently Fixed "End-On" Orientation of an Antibody for Detection.

In this study, the covalently fixed "end-on" orientation of a monoclonal antibody (mAb-) to amino terminated oligo (ethylene glycol)-capped gold nanoparticles (NH-TEG-AuNPs) was used to fabricate an in-house lateral flow strip (LFS), namely, the fixed "end-on" -mAb-NH-TEG-AuNPs LFS. The aim was to evaluate the performance of the fixed "end-on" -mAb-NH-TEG-AuNPs LFS in detecting . The proposed LFS enabled the sensitive detection of in 15 min with a visual limit of detection of 10 CFU/mL. Quantitative analysis indicated an LOD at 10 CFU/mL. The fixed "end-on" -mAb-NH-TEG-AuNPs LFS showed no cross-reactivity with other pathogenic bacteria and practical performance across different food matrices, including human blood, milk, and mushroom samples. Furthermore, the clinical performance of the fixed "end-on" -mAb-NH-TEG-AuNPs LFS for detecting was evaluated by using 12 clinical samples validated by the hemoculture method. It demonstrated excellent concordance with the reference methods, with no false-positive or false-negative results observed. Therefore, the fixed "end-on" -mAb-NH-TEG-AuNPs LFS serves as a promising candidate for a point-of-care test (POCT), enabling the rapid, precise, and highly sensitive detection of in clinical samples and contaminated food.