Automated sample-to-answer system for rapid and accurate diagnosis of emerging infectious diseases

• Published in: Sensors and actuators. B, Chemical Vol. 380; p. 133382
• Main Authors: Koo, Bonhan, Kim, Myoung Gyu, Lee, Kiri, Kim, Ji Yeun, Lee, Seungrag, Kim, Sung-Han, Shin, Yong
• Format: Journal Article
• Language: English
• Published: Lausanne Elsevier B.V 01.04.2023; Elsevier Science Ltd
• Subjects: Amplification; Automated sample-to-answer system; Automation; Bio-optical sensor; Clinical specimen; Coronaviruses; COVID-19; Diagnostic systems; Disease control; Emerging infectious disease; Infectious diseases; Microfluidic platform; Microfluidics; Nucleic acids; Optical fibers; Optical measuring instruments; Q fever; Sensors; Viral diseases; Microfluidic platform; Bio-optical sensor; Automated sample-to-answer system; Emerging infectious disease; Clinical specimen
• ISSN: 0925-4005; 1873-3077
• DOI: 10.1016/j.snb.2023.133382

Automated sample-to-answer systems that promptly diagnose emerging infectious diseases, such as zoonotic diseases, are crucial to preventing the spread of infectious diseases and future global pandemics. However, automated, rapid, and sensitive diagnostic testing without professionals and sample capacity and type limitations remains unmet needs. Here, we developed an automated sample-to-answer diagnostic system for rapid and accurate detection of emerging infectious diseases from clinical specimens. This integrated system consists of a microfluidic platform for sample preparation and a bio-optical sensor for nucleic acid (NA) amplification/detection. The microfluidic platform concentrates pathogens and NAs in a large sample volume using adipic acid dihydrazide and a low-cost disposable chip. The bio-optical sensor allows label-free, isothermal one-step NA amplification/detection using a ball-lensed optical fiber-based silicon micro-ring resonator sensor. The system is integrated with software to automate testing and perform analysis rapidly and simply; it can distinguish infection status within 80 min. The detection limit of the system (0.96 × 101 PFU) is 10 times more sensitive than conventional methods (0.96 × 102 PFU). Furthermore, we validated the clinical utility of this automated system in various clinical specimens from emerging infectious diseases, including 20 plasma samples for Q fever and 13 (11 nasopharyngeal swabs and 2 saliva) samples for COVID-19. The system showed 100% sensitivity and specificity for detecting 33 samples of emerging infectious diseases, such as Q fever, other febrile diseases, COVID-19, human coronavirus OC43, influenza A, and respiratory syncytial virus A. Therefore, we envision that this automated sample-to-answer diagnostic system will show high potential for diagnosing emerging infectious diseases in various clinical applications. •Developed an automated sample-to-answer diagnostic system for detection of emerging infectious diseases.•This system consists of a microfluidic platform for sample preparation and a bio-optical sensor for detection.•The microfluidic platform can concentrate pathogens and extract NAs simply using adipic acid dihydrazide (ADH).•The system is automatically operated within 80 min for detection of pathogens from clinical specimens.