Abstract
BACKGROUND
Severe 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.
OBJECTIVE
The 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/SETTING
The perspective was that of the UK NHS in 2020. The setting was a hypothetical hospital with an accident and emergency department.
METHODS
An 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.
RESULTS
A 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.
LIMITATIONS
There 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.
CONCLUSIONS
Should 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 WORK
More 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.
FUNDING
This 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 in Health Technology Assessment; Vol. 25, No. 21. See the NIHR Journals Library website for further project information.
Plain language summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes coronavirus disease 2019 (COVID-19). SARS-CoV-2 is highly infectious, and this can cause problems in hospitals, where the virus can spread quickly. Laboratory-based tests can determine whether or not a patient has SARS-CoV-2, but these tests are not perfect and can require a considerable time to provide a result. Point-of-care tests to detect SARS-CoV-2 are being developed that may have much shorter times to a test result, although these are likely to be less accurate than laboratory-based tests. The benefit of quicker tests is that a decision to put a patient in a SARS-CoV-2-infected bay or in a non-SARS-CoV-2-infected bay can be made sooner, limiting contact between patients with SARS-CoV-2 and patients without SARS-CoV-2 and reducing the risk of infection transmission. The disadvantage of reduced accuracy is that some patients may be allocated to the wrong bay, increasing the risk of SARS-CoV-2 infection. A computer model was built to explore the impact of using SARS-CoV-2 point-of-care tests for people admitted to hospital. This model estimated the number of infections and deaths due to COVID-19, the costs of testing, and the number of people waiting to be put in an appropriate bay. Strategies were run using different values, including the time to get a test result, the accuracy of tests and whether or not staff who do not have symptoms should be tested. The results of the model indicated that point-of-care tests could be good if there was a large reduction in the time to get a test result and if accuracy was high. However, it is not certain whether or not such tests will become available. When newer SARS-CoV-2 tests are available, the model will allow an estimate of the clinical effectiveness and cost-effectiveness of the test to be made.
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References
- WorldoMeter. COVID-19 Coronavirus Pandemic. 2020. URL: www.worldometers.info/coronavirus/ (accessed 15 November 2020).
- 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).
- 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).
- 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). [PubMed]
- Feng C, Huang Z, Wang L, Chen X, Zhai Y, Zhu F, et al. A novel triage tool of artificial intelligence assisted diagnosis aid system for suspected COVID-19 pneumonia in fever clinics. medRxiv 2020. https://doi.org/10.1101/2020.03.19.20039099 doi: 10.1101/2020.03.19.20039099. [DOI]
- Goodacre S, Thomas B, Lee E, Sutton L, Loban A, Waterhouse S, et al. Characterisation of 22445 patients attending UK emergency departments with suspected COVID-19 infection: observational cohort study. PLOS ONE 2020;15:e0240206. https://doi.org/10.1371/journal.pone.0240206 doi: 10.1371/journal.pone.0240206. [DOI] [PMC free article] [PubMed]
- NHS Digital. Hospital Accident and Emergency Activity, 2017–18. Leeds: NHS Digital; 2018. URL: https://digital.nhs.uk/data-and-information/publications/statistical/hospital-accident--emergency-activity/2017-18 (accessed 14 September 2020).
- Steventon A, Deeny S, Friebel R, Gardner T, Thorlby R. Briefing: Emergency Hospital Admissions in England: Which may be Avoidable and How? London: The Health Foundation; 2018.
- Docherty AB, Harrison EM, Green CA, Hardwick HE, Pius R, Norman L, et al. Features of 20 133 UK patients in hospital with covid-19 using the ISARIC WHO Clinical Characterisation Protocol: prospective observational cohort study. BMJ 2020;369:m1985. https://doi.org/10.1136/bmj.m1985 doi: 10.1136/bmj.m1985. [DOI] [PMC free article] [PubMed]
- Clifford S, Quilty B, Russell T, Liu Y, Chan Y-W, Pearson C, et al. Strategies to reduce the risk of SARS-CoV-2 reintroduction from international travellers. medRxiv 2020. https://doi.org/10.1101/2020.07.24.20161281 doi: 10.1101/2020.07.24.20161281. [DOI]
- He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, et al. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med 2020;26:672–5. https://doi.org/10.1038/s41591-020-0869-5 doi: 10.1038/s41591-020-0869-5. [DOI] [PubMed]
- Jefferson T, Spencer E, Brassey J, Heneghan C. Viral cultures for COVID-19 infectious potential assessment – a systematic review [published online ahead of print December 3 2020]. Clin Infect Dis 2020. https://doi.org/10.1093/cid/ciaa1764 doi: 10.1093/cid/ciaa1764. [DOI]
- Singanayagam A, Patel M, Charlett A, Lopez Bernal J, Saliba V, Ellis J, et al. Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020. Euro Surveill 2020;25. https://doi.org/10.2807/1560-7917.ES.2020.25.32.2001483 doi: 10.2807/1560-7917.ES.2020.25.32.2001483. [DOI] [PMC free article] [PubMed]
- NHS Digital. Hospital Admissions Hit Record High as Population Ages. Leeds: NHS Digital; 2016. URL: https://digital.nhs.uk/news-and-events/news-archive/2016-news-archive/hospital-admissions-hit-record-high-as-population-ages (accessed 14 September 2020).
- Baker C. Accident and Emergency Statistics: Demand, Performance and Pressure. London: House of Commons Library; 2017.
- Intensive Care National Audit and Research Centre (ICNARC). Key Statistics from the Case Mix Programme 2015-16 — Adult, General Critical Care Units. London: ICNARC; 2017.
- Meacock R, Anselmi L, Kristensen SR, Doran T, Sutton M. Higher mortality rates amongst emergency patients admitted to hospital at weekends reflect a lower probability of admission. J Health Serv Res Policy 2017;22:12–19. https://doi.org/10.1177/1355819616649630 doi: 10.1177/1355819616649630. [DOI] [PMC free article] [PubMed]
- Borakati A, Perera A, Johnson J, Sood T. Chest X-ray has poor diagnostic accuracy and prognostic significance in COVID-19: a propensity matched database study. medRxiv 2020. https://doi.org/10.1101/2020.07.07.20147934 doi: 10.1101/2020.07.07.20147934. [DOI]
- Doshi P. Covid-19: do many people have pre-existing immunity? BMJ 2020;370:m3563. https://doi.org/10.1136/bmj.m3563 doi: 10.1136/bmj.m3563. [DOI] [PubMed]
- Sutherland E, Donnarumma H. Coronavirus (COVID-19) Infection Survey Pilot: England and Wales, 11 September 2020. Newport: Office for National Statistics; 2020.
- Koh W, Naing L, Rosledzana M, Alikhan M, Chaw L, Griffith M, et al. What do we know about SARS-CoV-2 transmission? A systematic review and meta-analysis of the secondary attack rate, serial interval, and asymptomatic infection. medRxiv 2020. https://doi.org/10.1101/2020.05.21.20108746 doi: 10.1101/2020.05.21.20108746. [DOI] [PMC free article] [PubMed]
- Grassly NC, Pons-Salort M, Parker EPK, White PJ, Ferguson NM, Imperial College COVID-19 Response Team. Comparison of molecular testing strategies for COVID-19 control: a mathematical modelling study. Lancet Infect Dis 2020;20:1381–9. https://doi.org/10.1016/S1473-3099(20)30630-7 doi: 10.1016/S1473-3099(20)30630-7. [DOI] [PMC free article] [PubMed]
- Lavezzo E, Franchin E, Ciavarella C, Cuomo-Dannenburg G, Barzon L, Del Vecchio C, et al. Suppression of a SARS-CoV-2 outbreak in the Italian municipality of Vo’. Nature 2020;584:425–9. https://doi.org/10.1038/s41586-020-2488-1 doi: 10.1038/s41586-020-2488-1. [DOI] [PubMed]
- Centers for Disease Control and Prevention (CDC). Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19). Atlanta, GA: CDC; 2020. URL: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html (accessed 14 September 2020).
- Ferguson N, Laydon D, Nedjati-Gilani G, Imai N, Ainslie K, Baguelin M, et al., on behalf of the Imperial College COVID-19 Response Team. Report 9: Impact of Non-pharmaceutical Interventions (NPIs) to Reduce COVID-19 Mortality and Healthcare Demand. London: Imperial College London; 2020.
- Jarvis KF, Kelley JB. Temporal dynamics of viral load and false negative rate influence the levels of testing necessary to combat COVID19 spread. medRxiv 2020. https://doi.org/10.1101/2020.08.12.20173831 doi: 10.1101/2020.08.12.20173831. [DOI] [PMC free article] [PubMed]
- Collier DA, Assennato SM, Warne B, Sithole N, Sharrocks K, Ritchie A, et al. Point of care nucleic acid testing for SARS-CoV-2 in hospitalized patients: a clinical validation trial and implementation study. Cell Reports Med 2020;1:100062. https://doi.org/10.1016/j.xcrm.2020.100062 doi: 10.1016/j.xcrm.2020.100062. [DOI] [PMC free article] [PubMed]
- Department of Health and Social Care. Weekly Statistics for NHS Test and Trace (England) and Coronavirus Testing (UK): 3 September to 9 September. 2020. London: Department of Health and Social Care; 2020.
- Kim H, Hong H, Yoon SH. Diagnostic performance of CT and reverse transcriptase polymerase chain reaction for coronavirus disease 2019: a meta-analysis. Radiology 2020;296:E145–E155. https://doi.org/10.1148/radiol.2020201343 doi: 10.1148/radiol.2020201343. [DOI] [PMC free article] [PubMed]
- Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev 2020;8:CD013705. https://doi.org/10.1002/14651858.CD013705 doi: 10.1002/14651858.CD013705. [DOI] [PMC free article] [PubMed]
- Scheuber A. 90 Minute COVID-19 Tests: Government Orders 5.8 Million DnaNudge Kits. 2020. URL: www.imperial.ac.uk/news/201073/90-minute-covid-19-tests-government-orders/ (accessed 14 September 2020).
- Brazzelli M, Aucott L, Aceves-Martins M, Robertson C, Jacobsen E, Imamura M, et al. The ARCHITECT and Alinity Urine NGAL Assays, Urine NephroCheck Test, and Urine and Plasma NGAL Tests to Help Assess the Risk of Acute Kidney Injury for People who are Being Considered for Admission to Critical Care. Aberdeen: Aberdeen HTA Group, Institute of Applied Health Sciences, University of Aberdeen; 2019.
- NHS England and NHS Improvement. Healthcare Associated COVID-19 Infections – Further Action. London: NHS England; 2020.
- Office for National Statistics. Dataset: National Life Tables: UK. Newport: Office for National Statistics; 2019.
- Ara R, Brazier JE. Populating an economic model with health state utility values: moving toward better practice. Value Health 2010;13:509–18. https://doi.org/10.1111/j.1524-4733.2010.00700.x doi: 10.1111/j.1524-4733.2010.00700.x. [DOI] [PubMed]
- Carter B, Collins JT, Barlow-Pay F, Rickard F, Bruce E, Verduri A, et al. Nosocomial COVID-19 infection: examining the risk of mortality. The COPE-Nosocomial study (COVID in Older PEople). J Hosp Infect 2020;106:376–84. https://doi.org/10.1016/j.jhin.2020.07.013 doi: 10.1016/j.jhin.2020.07.013. [DOI] [PMC free article] [PubMed]
- Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of uncertainty in cost-effectiveness analysis. Med Decis Making 1998;18(Suppl. 2):68–80. https://doi.org/10.1177/0272989X98018002S09 doi: 10.1177/0272989X98018002S09. [DOI] [PubMed]
- Iacobucci G. Covid-19: Risk of death more than doubled in people who also had flu, English data show. BMJ 2020;370:m3720. https://doi.org/10.1136/bmj.m3720 doi: 10.1136/bmj.m3720. [DOI] [PubMed]
- Cuthbertson BH, Elders A, Hall S, Taylor J, MacLennan G, Mackirdy F, Mackenzie SJ, Scottish Critical Care Trials Group. Mortality and quality of life in the five years after severe sepsis. Crit Care 2013;17:R70. https://doi.org/10.1186/cc12616 doi: 10.1186/cc12616. [DOI] [PMC free article] [PubMed]
- Clark T, Brendish N, Poole S, Naidu V, Mansbridge C, Norton N, et al. Clinical impact of molecular point-of-care testing for suspected COVID-19 in hospital (COV-19POC): a prospective, interventional, non-randomised, controlled study. Lancet Respir Med 2020;8:1192–200. https://doi.org/10.1016/S2213-2600(20)30454-9 doi: 10.1016/S2213-2600(20)30454-9. [DOI] [PMC free article] [PubMed]