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.

Autor: Caffry J; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Selby M; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Barr K; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Morgan G; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., McGurk D; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Scully P; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Park C; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Caridis AM; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Southworth E; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Morrison J; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Clark DJ; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Davies BMO; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Eckersley NM; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Groppelli E; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Kirwan DE; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Monahan I; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Augustin Y; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK., Toombs C; QuantuMDx, Lugano Building, 57 Melbourne St, Newcastle Upon Tyne, UK., Planche T; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK.; St George's University Hospitals NHS Foundation Trust, London, UK., Staines HM; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK. hstaines@sgul.ac.uk., Krishna S; Clinical Academic Group in Institute for Infection and Immunity, St George's University of London, London, UK. s.krishna@sgul.ac.uk.; St George's University Hospitals NHS Foundation Trust, London, UK. s.krishna@sgul.ac.uk.; Institut für Tropenmedizin, Universitätsklinikum Tübingen, Tübingen, Germany. s.krishna@sgul.ac.uk.; Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon. s.krishna@sgul.ac.uk.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2023 Jun 17; Vol. 13 (1), pp. 9827. Date of Electronic Publication: 2023 Jun 17.
DOI: 10.1038/s41598-023-35479-9
Abstrakt: Accurate and rapid point-of-care (PoC) diagnostics are critical to the control 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) assays. Here, a preliminary prospective performance evaluation of the QuantuMDx Q-POC SARS-CoV-2 RT-PCR assay is reported. Between November 2020 and March 2021, 49 longitudinal combined nose/throat (NT) swabs from 29 individuals hospitalised with RT-PCR confirmed COVID-19 were obtained at St George's Hospital, London. In addition, 101 mid-nasal (MN) swabs were obtained from healthy volunteers in June 2021. These samples were used 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. The 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% (64.35-90.95% CI) without altering the reference test's Ct cut-off value of 40. The Q-POC test is a sensitive, specific and rapid PoC test for SARS-CoV-2 at a reference Ct cut-off value of 35. The Q-POC test provides an accurate option for RT-PCR at PoC without the need for sample pre-processing and laboratory handling, enabling rapid diagnosis and clinical triage in acute care and other settings.
(© 2023. The Author(s).)
Databáze: MEDLINE
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