Characterizing a visual lateral flow device for rapid SARS-CoV-2 virus protein detection: pre-clinical and system assessment

• DOI: 10.1039/d3ay02075d
• Publication Date: 2024-03-15T07:01:16Z
• Authors: Natpapas Wiriyach...; Jetnapang Kongrueng; Kannika Sukkuea; Rattana Tanrattan...; Jarunee Vanichtan...; Thanaya Saeyang; Tararat Jantra; Deanpen Japrung; Weerakanya Maneep...; Suwussa Bamrungsap; Pareena Janchompoo; Ekawat Pasomsub
• Keywords: 0303 health sciences; 03 medical and health sciences

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections have affected more than 769 million individuals worldwide over the last few years. Although pandemic is transitioning into an endemic, COVID-19 outbreak still a global concern. A rapid screening platform needed for effective preventive and control measures. Herein, visual lateral flow SARS-CoV-2 nucleocapsid protein detection developed. Under optimal conditions, system demonstrated good sensitivity selectivity against tested viruses. The provides direct with limit of 0.7 ng per mL sample (0.7 mL-1) within 15 minutes. Further, correlation between semi-quantitative analysis using reader showed similar (R2 = 0.9571). repeatability reproducibility studies highlighted potential infection, variations 5% 10% at high low concentrations, respectively. Subsequent pre-clinical validation to correlate performance standard molecular approach (RT-PCR) 170 nasopharyngeal swabs 98% estimated (95% CI, 89.35-99.95%) 100% specificity 96.38-100%). positive negative predictive values were reported be 99%, respectively, accuracy 99.3%. With viral load samples (Ct value ≤25, n 47), specificity. proposed technique valuable use in screening, particularly during pandemics, where diagnostic capacity mass are crucial.