ABSTRACT
Intro: In Australia, the main methods to diagnose COVID-19 are through rapid antigen tests (RATs) and through nucleic acid amplification testing (NAAT, including polymerase chain reaction) on healthcare worker (HCW)-collected combined nose/throat swabs. With self-collection widely used by the public for RATs, the aim of this study was to evaluate the performance of self-collected samples using commercial NAAT for SARS-CoV-2. Method(s): Consenting participants aged 14 years and older were provided with a self-collection pack containing instructions and either a FLOQSwab (Copan) or a Rhinoswab (Rhinomed). Participants collected their own nasal sample unsupervised prior to having a HCW-collected combined nose and throat swab taken for standard of care NAAT. Paired self-collected and HCW samples were tested on the cobas SARS-CoV-2 assay (Roche) and the Aptima SARS-CoV-2 assay (Hologic). Finding(s): We demonstrated comparable sensitivity, specificity, and agreement between self-collected nasal and Rhinoswab samples, compared to HCW- collected samples tested using the cobas SARS-CoV-2 and Aptima SARS-CoV-2 assays. In our study the clinical performance of self-collected specimens was comparable to HCW-collected samples, with both self-collect nasal and Rhinoswab samples resulting in 90-95% sensitivity, and in most cases >95% specificity. Discussion(s): Without the availability of samples for NAAT the ability to perform genomic testing is limited, reducing surveillance and public health investigations. We showed that genomic sequencing from self-collected samples can correctly identify the virus lineage and that the main determination of successful genomic testing is a high viral load rather than collection method. Conclusion(s): These data support self-collection as an accessible method for community testing for COVID-19 and introduces a novel collection device, the Rhinoswab as an alternative to the standard nasal swab. The testing method of self-collection can be expanded from the widely used RATs to NAAT and genomic testing which may inform the management and public health response to the COVID-19 pandemic.Copyright © 2023
ABSTRACT
Background: The COVID-19 pandemic required a rapid response and need for real-world data in cancer patients. The nationwide, real-time coordinated UKCCMP reporting network provided an immediate solution. Methods: The ability to set up an interdisciplinary multi-organisational team quickly, covering expert knowledge from clinical, legal, statistical, and computer science was essential. The technical infra-structure allows clinician-led anonymised data entry and rapid dissemination of results with a clinical (RedCap) database as core. However the development of a national cancer reporting network was crucial for the viability of the project. From its inception in March 2020 the reporting network was established via 4 iterative phases. Results: Within the first 4 weeks, >50 centres were involved with coverage throughout the UK. Expansion has continued with >70 centres within 6 weeks reporting over 1200 COVID positive cancer patients. This was achieved through a 4-phase approach: phase 1 - Outline: This involved project protocol development where key data and timelines were confirmed by a small project team followed by whole-team sign-off. phase 2 - Engagement: This involved identification and engagement of existing groups to establish an initial network. Professional body endorsement led to increased recognition and utilisation of their membership networks. Finally regional leads were identified. phase 3 - Invitation: The third phase involved the distribution of a formal invite letter via identified networks. Project specific email and standard mailing lists were created to enhance network identity and communication. phase 4 - Consolidation: Early development of an interactive project website and focus on communication via social media with varied content consolidated interest and led to further extension. Conclusions: Real-time reporting of real world data can be achieved with clearly defined project phases, standardised documentation and an iterative recruitment process. The COVID-19 pandemic necessitated a rapid response, proving that similar reporting networks can be set up quickly and robustly to react to the evidence-based needs of the oncology community in the drive for implementation of change. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: A.C. Olsson-Brown: Honoraria (self): Roche;Honoraria (institution): Roche;Honoraria (self): Bristol Myers Squibb;Research grant/Funding (institution): Bristol Myers Squibb;Research grant/Funding (institution): USB Pharma;Research grant/Funding (institution): Eli Lily;Research grant/Funding (institution): Novartis. D.J. Hughes: Honoraria (self): Novartis;Research grant/Funding (self): NanoMab Technology LtD. S. Sivakumar: Research grant/Funding (self): Celgene. All other authors have declared no conflicts of interest.