TY - JOUR
T1 - PATHPOD – A Loop-Mediated Isothermal Amplification (LAMP)-based Point-of-Care System for Rapid Clinical Detection of SARS-CoV-2 in Hospitals in Denmark
AU - Nguyen, Trieu
AU - Vinayaka, Aaydha Chidambara
AU - Huynh, Van Ngoc
AU - Linh, Quyen Than
AU - Andreasen, Sune Zoëga
AU - Golabi, Mohsen
AU - Bang, Dang Duong
AU - Møller, Jens Kjølseth
AU - Wolff, Anders
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - SARS-CoV-2
KW - COVID-19 pandemic
KW - Point of care (PoC) device
KW - Reverse-transcription, loop-mediated isothermal amplification
KW - Limit of detection (LOD)
KW - Clinical sensitivity
U2 - 10.1016/j.snb.2023.134085
DO - 10.1016/j.snb.2023.134085
M3 - Journal article
C2 - 37304211
SN - 0925-4005
VL - 392
JO - Sensors and Actuators B: Chemical
JF - Sensors and Actuators B: Chemical
M1 - 134085
ER -