As part of a COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR), members from the Northern Medical Physics and Clinical Engineering Team (NMPCE), working as part of the NIHR Newcastle In Vitro Diagnostics Co-operative (NIHR Newcastle MIC), have been concentrating their efforts on the evaluation of COVID-19 diagnostics within multiple settings.
Collaborating with multiple centres, including Imperial College London, Manchester Diagnostics and Technology Accelerator and three other NIHR MedTech In Vitro Diagnostic Co-operatives (MICs) with expertise in evaluating in vitro diagnostics, the NIHR Newcastle MIC has been analysing patient pathways for the possible introduction of new Rapid and Point-of-Care tests for COVID-19 in multiple healthcare settings.
Unmet clinical needs for COVID-19 tests in UK health and social care settings
Members of the NMPCE and NIHR Newcastle MIC, in collaboration with methodologists from the NIHR Leeds MIC, NIHR London MIC, and NIHR Oxford MIC designed and delivered a survey to collect 447 UK wide health and social care professionals’ views on COVID-19 testing. Individuals from these different sectors were asked about current COVID-19 diagnostic testing availability and issues in their working environments. The paper was published in the journal PLOS One.
Our analysis showed that the greatest perceived unmet clinical need for COVID-19 diagnostic tests were in hospitals and care homes. Across all settings, the most serious perceived problem with testing was the long turnaround time for results, with the potential spread of infection being considered the greatest consequence associated with the lack of testing.
Within hospitals the highest priority was for a test which could identify COVID-19 in hospital workers and patients with symptoms. Whilst within care homes the ultimate need was for a test that could be used on newly admitted residents to prevent transmission to existing residents and staff.
COVID-19 testing in English care homes and implications for staff and residents
In conjunction with methodologists from Imperial College London and the NIHR London MIC, the NMPCE and NIHR Newcastle MIC interviewed employees from 10 different care homes with regards to COVID-19 testing in the first wave. We mapped the decision processes, identified key stakeholders and consequently highlighted the potential barriers to incorporating point-of-care tests in care homes. The paper was published in the journal Age and Ageing.
Our work identified four main steps in testing: infection prevention, preparatory steps, swabbing procedure and management of residents. We identified challenges for testing at each stage of the process, focusing on potential barriers and the key stakeholders within each stage.
Our analysis revealed that onsite testing within care homes could help to reduce the current burden associated with requesting and registering offsite laboratory COVID-19 tests. Rapid testing could also help to accommodate the needs of residents with dementia. There was enthusiasm for rapid tests that use samples that require a less invasive collection method than nose and throat swabs. Quicker results would help care home staff decide whether to send residents with suspected COVID-19 to hospital. A faster result would also save residents without COVID-19 from prolonged and unnecessary periods of isolation.
Care pathway and prioritization of rapid testing for COVID-19 in UK hospitals: a qualitative evaluation
Methodologists from NMPCE and NIHR Newcastle collaborated with CONDOR partners to examine clinical opinion and pinpoint where rapid COVID-19 testing could have the greatest impact in UK hospitals. We conducted and analysed interviews with 16 clinicians from 12 NHS Trusts across England. They represented 10 different specialisms covering urgent, acute, and elective admissions. This enabled us to determine the sequence of interactions a patient with suspected COVID-19 experiences as they navigate through different hospital settings. The paper was published in the journal BMC Health Services Research.
Our results indicated that priority for rapid testing should be given to hospitals with limited access to laboratory services and availability of single rooms. Our research also implied that rapid testing would also be valuable in settings where urgent decisions need to be made such as emergency surgery, maternity services and organ transplant departments. This may help to reduce viral transmission within areas of the hospital where patients are waiting for test results. This work strongly influenced detailed economic modelling for diagnostic testing within hospitals which was commissioned by NICE.
We have also conducted two systematic reviews to provide the research community with a solid knowledge base of the pandemic.
At what times during infection is SARS-CoV-2 detectable and no longer detectable using RT-PCR-based tests? A systematic review of individual participant data
Working within a national, synergistic collaboration we produced a systematic review of 32 studies with data from individual participants with confirmed SARS-CoV2, tested at multiple times during their infection by RT-PCR. The study was led by Sue Mallet (University College London) and involved 6 universities, Kleijnen Systematic Reviews Ltd and the Frimley Health NHS Foundation Trust. We used robust methods to synthesise published literature and identify patterns that would not be possible from individual articles. The paper was published in the journal BMC Medicine.
Our analysis indicated that the sample site within the body, and the time of testing during the condition, influences whether infected individuals are identified by RT-PCR molecular tests. To avoid the consequences of missed infection, samples for RT-PCR molecular testing should be taken as soon as symptoms start. Beyond 10 days from the onset of symptoms, using lower respiratory tract (e.g. sputum) or faecal samples is a preferred option. This review provided the research community with a solid knowledge base of the pandemic. Some hospitals in the UK now routinely take RT-PCR samples from multiple sites, such as the nose and throat.
Utility of Routine Laboratory Biomarkers to Detect COVID-19: A Systematic Review and Meta-Analysis
Through collaboration with the health economics group within the Population Health Sciences Institute at Newcastle University, NPMCE and NIHR Newcastle MIC methodologists conducted a systematic review and meta-analysis to explore routine laboratory measurements and their potential use for differentiating COVID-19 positive and negative patients. The paper was published in Viruses.
We identified decreased neutrophil, lymphocyte, eosinophil, and platelet counts in COVID-19 positive compared to COVID-19 negative patients. While biomarkers including lactate dehydrogenase, aspartate aminotransferase, and alanine aminotransferase were elevated in COVID-19-positive compared to COVID-19-negative patients.
This work could help inform further development of clinical scoring algorithms, which are likely to be important for use in clinical settings that do not have access to point-of-care or laboratory testing for COVID-19.
Engaging with the public around COVID-19 testing
We have also raised the importance of evaluating COVID-19 tests with the public. The NIHR Newcastle MIC insight panel for patients, public and carers helped us develop, deliver and design a public event to explain the complexities around measuring the accuracy of COVID-19 tests. Our discussions with the attendees informed our work within CONDOR and our opinion article. We also discussed our COVID-19 work with the public at the Pint of Science Festival.