PATHPOD – A Loop-Mediated Isothermal Amplification (LAMP)-based Point-of-Care System for Rapid Clinical Detection of SARS-CoV-2 in Hospitals in Denmark

Trieu Nguyen, Aaydha Chidambara Vinayaka, Van Ngoc Huynh, Quyen Than Linh, Sune Zoëga Andreasen, Mohsen Golabi, Dang Duong Bang, Jens Kjølseth Møller, Anders Wolff*

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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Abstract

Sensitive and rapid detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a vital goal in the ongoing COVID-19 pandemic. We present in this comprehensive work, for the first time, detailed fabrication and clinical validation of a point of care (PoC) device for rapid, onsite detection of SARS-CoV-2 using a real-time reverse-transcription loop-mediated isothermal amplification (RT-rLAMP) reaction on a polymer cartridge. The PoC system, namely PATHPOD, consisting of a standalone device (weight less than 1.2 kg) and a cartridge, can perform the detection of 10 different samples and two controls in less than 50 minutes, which is much more rapid than the golden standard real-time reverse-transcription Polymerase Chain Reaction (RT-rPCR), typically taking 16-48 hours. The novel total internal reflection (TIR) scheme and the reactions inside the cartridge in the PoC device allow monitoring of the diagnostic results in real-time and onsite. The analytical sensitivity and specificity of the PoC test are comparable with the current RT-rPCR, with a limit of detection (LOD) down to 30 to 50 viral genome copies. The robustness of the PATHPOD PoC system has been confirmed by analyzing 398 clinical samples initially examined in two hospitals in Denmark. The clinical sensitivity and specificity of these tests are discussed.
Original languageEnglish
Article number134085
JournalSensors and Actuators B: Chemical
Volume392
Number of pages13
ISSN0925-4005
DOIs
Publication statusPublished - 2023

Keywords

  • SARS-CoV-2
  • COVID-19 pandemic
  • Point of care (PoC) device
  • Reverse-transcription, loop-mediated isothermal amplification
  • Limit of detection (LOD)
  • Clinical sensitivity

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