The QuantuMDx Q-POC? SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology
The QuantuMDx Q-POC? SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology
Abstract BackgroundAccurate, affordable, and rapid point-of-care (PoC) diagnostics are critical to the global control and management of the COVID-19 pandemic. The current standard for accurate diagnosis of SARS-CoV-2 is laboratory-based reverse transcription polymerase chain reaction (RT-PCR). Here, we report a preliminary prospective performance evaluation of the QuantuMDx Q-POC? SARS CoV-2 RT-PCR assay. MethodsBetween November 2020 and March 2021, we obtained 49 longitudinal nose and throat swabs from 29 individuals hospitalised with RT-PCR confirmed COVID-19 at St George’s NHS Foundation Trust, London (UK). In addition, we obtained 101 mid nasal swabs from healthy volunteers in June 2021. We then used these samples to evaluate the Q-POC? SARS-CoV-2 RT-PCR assay. The primary analysis was to compare the sensitivity and specificity of the Q-POC? test against a reference laboratory-based RT-PCR assay. ResultsThe overall sensitivity of the Q-POC? test compared with the reference test was 96.88% (83.78%-99.92% CI) for a cycle threshold (Ct) cut-off value for the reference test of 35 and 80.00% (64.35% to 90.95% CI) without altering the reference test’s Ct cut-off value of 40. ConclusionsThe Q-POC? test is a sensitive, specific and rapid point-of-care test for SARS-CoV-2 at a reference Ct cut-off value of 35. The Q-POC? test provides an accurate and affordable option for RT-PCR at point-of-care without the need for sample pre-processing and laboratory handling. The Q-POC? test would enable rapid diagnosis and clinical triage in acute care and other settings.
Caffry Jessica、Selby Matthew、Morgan George、McGurk David、Caridis Anna-Maria、Southworth Emily、Morrison Jack、Clark David J、Kirwan Daniela E.、Planche Tim、Staines Henry M、Krishna Sanjeev、Groppelli Elisabetta、Augustin Yolanda、Eckersely Nickolas、Monahan Irene、Scully Philip、Toombs Colin、Park Catherine、Barr Katie
QuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of London||St George?ˉs University Hospitals NHS Foundation TrustCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of London||St George?ˉs University Hospitals NHS Foundation Trust||Institut f¨1r Tropenmedizin, Universit?tsklinikum T¨1bingen||Centre de Recherches M¨|dicales de Lambar¨|n¨|Centre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonCentre for Diagnostics & Antimicrobial Resistance, Clinical Academic Group in Institute for Infection & Immunity, St George?ˉs University of LondonQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano BuildingQuantuMDx, Lugano Building
医学研究方法临床医学基础医学
DiagnosticsRT-PCRPoint-of-careCOVID-19SARS-CoV-2
Caffry Jessica,Selby Matthew,Morgan George,McGurk David,Caridis Anna-Maria,Southworth Emily,Morrison Jack,Clark David J,Kirwan Daniela E.,Planche Tim,Staines Henry M,Krishna Sanjeev,Groppelli Elisabetta,Augustin Yolanda,Eckersely Nickolas,Monahan Irene,Scully Philip,Toombs Colin,Park Catherine,Barr Katie.The QuantuMDx Q-POC? SARS-CoV-2 RT-PCR assay for rapid detection of COVID-19 at point-of-care: preliminary evaluation of a novel technology[EB/OL].(2025-03-28)[2025-06-10].https://www.medrxiv.org/content/10.1101/2021.07.12.21260119.点此复制
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