Affiliation:
1. School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
2. Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
3. NIHR Leeds Medtech and In Vitro Diagnostics Co-operative, Leeds, UK
Abstract
BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes coronavirus disease 2019. At the time of writing (October 2020), the number of cases of COVID-19 had been approaching 38 million and more than 1 million deaths were attributable to it. SARS-CoV-2 appears to be highly transmissible and could rapidly spread in hospital wards.ObjectiveThe work undertaken aimed to estimate the clinical effectiveness and cost-effectiveness of viral detection point-of-care tests for detecting SARS-CoV-2 compared with laboratory-based tests. A further objective was to assess occupancy levels in hospital areas, such as waiting bays, before allocation to an appropriate bay.Perspective/settingThe perspective was that of the UK NHS in 2020. The setting was a hypothetical hospital with an accident and emergency department.MethodsAn individual patient model was constructed that simulated the spread of disease and mortality within the hospital and recorded occupancy levels. Thirty-two strategies involving different hypothetical SARS-CoV-2 tests were modelled. Recently published desirable and acceptable target product profiles for SARS-CoV-2 point-of-care tests were modelled. Incremental analyses were undertaken using both incremental cost-effectiveness ratios and net monetary benefits, and key patient outcomes, such as death and intensive care unit care, caused directly by COVID-19 were recorded.ResultsA SARS-CoV-2 point-of-care test with a desirable target product profile appears to have a relatively small number of infections, a low occupancy level within the waiting bays, and a high net monetary benefit. However, if hospital laboratory testing can produce results in 6 hours, then the benefits of point-of-care tests may be reduced. The acceptable target product profiles performed less well and had lower net monetary benefits than both a laboratory-based test with a 24-hour turnaround time and strategies using data from currently available SARS-CoV-2 point-of-care tests. The desirable and acceptable point-of-care test target product profiles had lower requirement for patients to be in waiting bays before being allocated to an appropriate bay than laboratory-based tests, which may be of high importance in some hospitals. Tests that appeared more cost-effective also had better patient outcomes.LimitationsThere is considerable uncertainty in the values for key parameters within the model, although calibration was undertaken in an attempt to mitigate this. The example hospital simulated will also not match those of decision-makers deciding on the clinical effectiveness and cost-effectiveness of introducing SARS-CoV-2 point-of-care tests. Given these limitations, the results should be taken as indicative rather than definitive, particularly cost-effectiveness results when the relative cost per SARS-CoV-2 point-of-care test is uncertain.ConclusionsShould a SARS-CoV-2 point-of-care test with a desirable target product profile become available, this appears promising, particularly when the reduction on the requirements for waiting bays before allocation to a SARS-CoV-2-infected bay, or a non-SARS-CoV-2-infected bay, is considered. The results produced should be informative to decision-makers who can identify the results most pertinent to their specific circumstances.Future workMore accurate results could be obtained when there is more certainty on the diagnostic accuracy of, and the reduction in time to test result associated with, SARS-CoV-2 point-of-care tests, and on the impact of these tests on occupancy of waiting bays and isolation bays. These parameters are currently uncertain.FundingThis report was commissioned by the National Institute for Health Research (NIHR) Evidence Synthesis programme as project number 132154. This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 25, No. 21. See the NIHR Journals Library website for further project information.
Funder
Health Technology Assessment programme
Publisher
National Institute for Health Research
Reference40 articles.
1. National Institute for Health and Care Excellence. Exploratory Economic Modelling of SARS-CoV-2 Viral Detection Point of Care Tests and Serology Tests. Final Scope. London: NICE; 2020. URL: www.nice.org.uk/guidance/gid-dg10038/documents/final-scope (accessed 19 January 2021).
2. Medicines and Healthcare products Regulatory Agency (MHRA). TARGET PRODUCT PROFILE. Point of Care SARS-CoV-2 Detection Tests. London: MHRA; 2020. URL: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/895745/TPP_Point_of_Care_SARS-CoV-2_Detection_Tests.pdf (accessed 16 July 2020).
3. National Institute for Health and Care Excellence. Guide to the Methods of Technology Appraisal 2013. London: NICE; 2013. URL: www.nice.org.uk/process/pmg9/ (accessed 7 September 2020).
4. A novel triage tool of artificial intelligence assisted diagnosis aid system for suspected COVID-19 pneumonia in fever clinics;Feng,2020
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