On-Site Remote Monitoring System with NIR Signal-Based Detection of Infectious Disease Virus in Opaque Salivary Samples.

Abstract

Infectious disease viruses, such as foot-and-mouth disease virus (FMDV), are highly contagious viruses that cause significant socioeconomic damage upon spreading. Developing an on-site diagnostic tool for early clinical detection and real-time surveillance of FMDV outbreaks is essential to prevent the further spread of the disease. However, early diagnosis of FMDV is still challenging due to the limited sensitivity and time-consuming manual result entry of commercial on-site tests for salivary samples. Here, we report a near-infrared (NIR) signal nanoprobe-based highly accurate detection and remote monitoring system toward FMDVs, which automates the analysis and reporting of diagnosis data. The NIR signal lateral flow immunoassay (LFA) was assembled with a nanoprobe with a stable emission intensity at 800 nm, minimizing the interference signal of opaque salivary samples. We investigated the clinical applicability of the NIR signal LFA at biosafety level 3 (BSL-3) laboratories using 147 opaque salivary samples. The NIR signal LFA achieved a 32-fold lower limit of detection (LOD) than a commercial LFA in detecting live FMDVs, including all isolates occurring in the Republic of Korea during 2010-2017. Our results showed that the NIR signal LFA successfully discriminated the FMDV-positive clinical salivary samples from healthy controls with a sensitivity of 96.9%, specificity of 100.0%, and AUC (area under the receiver operator characteristic curve) value of 0.999. Finally, we substantiated the real-time collection of diagnostic results using a customized portable NIR reader at nine different laboratories of government-certified quarantine institutions for foot-and-mouth disease (FMD).