Assessing a novel, lab-free, point-of-care test for SARS-CoV-2 (CovidNudge): a diagnostic accuracy study
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SciScore for 10.1101/2020.08.13.20174193: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Verbal or written consent for an additional swab was obtained from each participant and results from POC testing were not fed back to the individual participants.
IACUC: Analysis of Group 3 was conducted as a service evaluation approved by the Point of Care Committee at Chelsea & Westminster NHS Foundation Trust and results were used to inform patient care.Randomization not detected. Blinding Staff performing centralized laboratory testing were blinded to the POC test results and vice-versa. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources The DnaCartridge consists of two main … SciScore for 10.1101/2020.08.13.20174193: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Verbal or written consent for an additional swab was obtained from each participant and results from POC testing were not fed back to the individual participants.
IACUC: Analysis of Group 3 was conducted as a service evaluation approved by the Point of Care Committee at Chelsea & Westminster NHS Foundation Trust and results were used to inform patient care.Randomization not detected. Blinding Staff performing centralized laboratory testing were blinded to the POC test results and vice-versa. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources The DnaCartridge consists of two main parts: an amplification unit (AU) and a sample preparation unit (SPU). DnaCartridgesuggested: NoneStudy Design & Participants: Clinical assessment took place at three sites in the United Kingdom: St Mary’s Hospital, Imperial Healthcare NHS Trust, London (IHCT); Chelsea & Westminster Hospital NHS Foundation Trust, London (CWFT) and the John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford (OUH). Imperial Healthcaresuggested: NoneThe Abbott (Illinois, United States) real-time SARS-CoV-2 assay is a dual-target real-time RT-PCR assay targeting conserved regions of the RdRp and N-genes, run on an Abbott M2000 machine. Abbottsuggested: (Abbott, RRID:SCR_010477)Primers and Probes: Exclusivity of the assays with respect to the Coronaviridae family was evaluated in silico by mapping the primer and probe sequences to homologous sequences downloaded from the NCBI database. NCBIsuggested: (NCBI, RRID:SCR_006472)NCBI primer-BLAST tool was used to assess potential cross- reactivity with other respiratory pathogens and high-priority organisms. primer-BLASTsuggested: (Primer-BLAST, RRID:SCR_003095)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:We acknowledge the limitations of our study. The clinical assessment took place during a period of exceptionally heavy demand on clinical and laboratory services in the UK. It was not possible to use a single laboratory platform for comparison as the supply of reagents was inconsistent and unpredictable. Cross-platform comparison of two laboratory platforms was performed in a subset of samples. Given the POC assay had comparable performance against a range of other commercial platforms run in different labs, it is reasonable to expect that similar performance would be observed in different clinical settings. Following recent CE marking to allow testing outside of hospitals, and NHS procurement, a standard process for the roll-out is being developed by the NHS taking into account this issue. Nevertheless, we advocate for local assessment to compare performance against existing local standards of care when the device is first deployed in a new setting. Falling incidence of infection during the period of study meant it was not possible to validate the test with a larger number of positive samples, however, the high specificity in a cohort with low background prevalence is reassuring given the risks of incorrectly placing a patient without infection into a ward designated for SARS-CoV-2 infected patients. Centralised testing with RT-PCR has the advantage of high throughput processing that cannot be achieved by the CovidNudge platform at the current time. As each processing unit (...
Results from TrialIdentifier: No clinical trial numbers were referenced.
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.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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