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
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Abstract
Background
Accurate, 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.
Methods
Between 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.
Results
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% to 90.95% CI) without altering the reference test’s Ct cut-off value of 40.
Conclusions
The 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.
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SciScore for 10.1101/2021.07.12.21260119: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical statement: Ethical approval for clinical sample use at SGUL was provided by the Institutional Review Board as part of the “Development and Assessment of Rapid Testing for SARS-CoV-2 outbreak” (DARTS) study, sponsored by St George’s Hospital NHS Foundation Trust (Integrated Research Application System project ID: 282104; South Central - Oxford C Research Ethics Committee reference: 20/SC/0171; registered at clinicaltrials.gov NCT04351646).
Consent: All participants for this study were recruited following informed consent.Sex as a biological variable not detected. Randomization not detected. Blinding Statistical analysis: Operators were not blinded to the status of patients/volunteers … SciScore for 10.1101/2021.07.12.21260119: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: Ethical statement: Ethical approval for clinical sample use at SGUL was provided by the Institutional Review Board as part of the “Development and Assessment of Rapid Testing for SARS-CoV-2 outbreak” (DARTS) study, sponsored by St George’s Hospital NHS Foundation Trust (Integrated Research Application System project ID: 282104; South Central - Oxford C Research Ethics Committee reference: 20/SC/0171; registered at clinicaltrials.gov NCT04351646).
Consent: All participants for this study were recruited following informed consent.Sex as a biological variable not detected. Randomization not detected. Blinding Statistical analysis: Operators were not blinded to the status of patients/volunteers from which the samples were taken prior to Q-POC™ testing but did not have access to the results of the subsequent reference testing; however, the Q-POC™ requires no subjective interpretation of a result. Power Analysis not detected. Table 2: Resources
Software and Algorithms Sentences Resources Data were analysed with GraphPad Prism (version 6.07 for Windows). GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:One way to circumvent some of these limitations is to repurpose high quality NAAT based testing platforms to deal with new infections such as caused by SARS-CoV-2. The COVID-19 pandemic highlighted an urgent need for PoC methods to detect SARS-CoV-2, including its variants. To address this, QuantuMDx initially developed a laboratory based multiplex assay with simple to use lyophilised reagents that are stable when stored at room temperature, and quicker to run than many others (see (3)). However, these tests require automated equipment and batch testing, and cannot give rapid results for individual assessment. QuantuMDx therefore repurposed cassettes, the portable analytical platform and software to provide an accurate, affordable and simple to use PoC test for SARS-CoV-2, as detailed in Methods. Here it is demonstrated that using a reference test Ct cut-of 35 that the Q-POC™ test for SARS-CoV-2 had a sensitivity of 96.88% (83.78%-99.92% CI) and a specificity of 98.3% (82.2-99.9%). These performance characteristics are comparable or better than other PoC NAAT devices (7-10). Advantages of the Q-POC™ include a rapid run-time (∼32 minutes) compared with laboratory-based diagnostic platforms and some PoC NAAT devices also (e.g. (7, 8)). The Q-POC™ swab buffer is loaded directly into a fully sealed cartridge without the need for any extraction or sample processing steps. The sealed cartridge system also allows safe testing outside a laboratory, including primary care and communit...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04351646 Not yet recruiting Diagnostics of COVID-19/DARTS (Development and Assessment of… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- No funding statement was detected.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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