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Review 2: "A handheld point-of-care system for rapid detection of SARS-CoV-2 in under 20 minutes"

The portable diagnostic platform presented is an indispensable molecular diagnostic solution for COVID-19. Built with secure cloud connectivity, it can enable real-time case identification and epidemiological surveillance. Comparisons are needed.

Published onAug 11, 2020
Review 2: "A handheld point-of-care system for rapid detection of SARS-CoV-2 in under 20 minutes"
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key-enterThis Pub is a Review of
A handheld point-of-care system for rapid detection of SARS-CoV-2 in under 20 minutes
Description

The COVID-19 pandemic is a global health emergency characterized by the high rate of transmission and ongoing increase of cases globally. Rapid point-of-care (PoC) diagnostics to detect the causative virus, SARS-CoV-2, are urgently needed to identify and isolate patients, contain its spread and guide clinical management. In this work, we report the development of a rapid PoC diagnostic test (< 20 min) based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) and semiconductor technology for the detection of SARS-CoV-2 from extracted RNA samples. The developed LAMP assay was tested on a real-time benchtop instrument (RT-qLAMP) showing a lower limit of detection of 10 RNA copies per reaction. It was validated against 183 clinical samples including 127 positive samples (screened by the CDC RT-qPCR assay). Results showed 90.55% sensitivity and 100% specificity when compared to RT-qPCR and average positive detection times of 15.45 ± 4.43 min. For validating the incorporation of the RT-LAMP assay onto our PoC platform (RT-eLAMP), a subset of samples was tested (n=40), showing average detection times of 12.89 ± 2.59 min for positive samples (n=34), demonstrating a comparable performance to a benchtop commercial instrument. Paired with a smartphone for results visualization and geo-localization, this portable diagnostic platform with secure cloud connectivity will enable real-time case identification and epidemiological surveillance.

RR:C19 Evidence Scale rating by reviewer:

  • Strong. The main study claims are very well-justified by the data and analytic methods used. There is little room for doubt that the study produced has very similar results and conclusions as compared with the hypothetical ideal study. The study’s main claims should be considered conclusive and actionable without reservation.

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Review:

The COVID-19 pandemic has shed light of the difficulty to have a large testing capacity running. If we rely only on centralized labs with trained technicians, the issue will be even bigger. We need a molecular diagnostic solution easily accessible.

In this study Rodriguez-Manzano et al. report the development of a rapid point of care diagnostic test based on reverse transcriptase loop-mediated isothermal amplification (RT-LAMP).

The authors used the primers sequence and the LAMP assay reported by Zhang et al. in February 2020 (https://www.medrxiv.org/content/10.1101/2020.02.26.20028373v1). Their LAMP has a lower limit of detection of 10 RNA copies per reaction and was validated against 183 clinical samples including 127 positive samples (screened by the CDC RT-qPCR assay).

They were able to reach showed 90.55% sensitivity and 100% specificity when compared to RT-qPCR.

The innovative part of the study was the integration of a point-of care platform linked to a mobile device. Although their sample side was pretty limited (n= 40 samples), they were able to detect and quantify the presence of SARS-CoV-2 in the extracted clinical samples, with similar performance between the RT-qLAMP and the RT-eLAMP.


Although the LAMP assay by itself is not original and was already published, the authors were able:


1- To validate LAMP assay for the detection of SARS-Cov-2 with a 100% of specificity
2- Their point of care with integrated sensors and corresponding algorithms allow to detect and quantify the presence of SARS-CoV-2.
This portable diagnostic platform, is without doubt, an indispensable addition to the need of molecular diagnostic solution.

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