Horses for courses? Assessing the potential value of a surrogate, point‐of‐care test for SARS‐CoV‐2 epidemic control

Ismail, Sharif; Huntley, Catherine; Post, Nathan; Rigby, S.E.; Shrotri, Madhumita; Williams, Sarah; Peacock, Sharon J.

doi:10.1111/irv.12796

Cited by 8 publications

(9 citation statements)

References 19 publications

(36 reference statements)

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“…18 FebriDx could be useful as an early triage tool to identify patients with COVID-19 and help guide isolation and IPC in patients needing admission to hospital. [18][19][20][21] We therefore developed and implemented a COVID-19 triage algorithm, supported by FebriDx, to inform patient flow from the ED while awaiting RT-PCR results. Here, we describe the diagnostic performance of this algorithm compared with SARS-CoV-2 RT-PCR.…”

Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

“…FebriDx testing was implemented as part of routine clinical care in response to data on assay performance for COVID-19 and an urgent clinical need. 21 Results are reported in compliance with Standards for Reporting of Diagnostic Accuracy Studies (STARD) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines (see online supplemental materials). The FebriDx tests were purchased independently Open access from a UK distributer, and the manufacturer had no role in the study conception, design, data analysis or manuscript preparation.…”

Section: Ethics Approvalmentioning

confidence: 99%

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Utility of the FebriDx point-of-care assay in supporting a triage algorithm for medical admissions with possible COVID-19: an observational cohort study

et al. 2021

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ObjectiveTo evaluate a triage algorithm used to identify and isolate patients with suspected COVID-19 among medical patients needing admission to hospital using simple clinical criteria and the FebriDx assay.DesignRetrospective observational cohort.SettingLarge acute National Health Service hospital in London, UK.ParticipantsAll medical admissions from the emergency department between 10 August 2020 and 4 November 2020 with a valid SARS-CoV-2 RT-PCR result.InterventionsMedical admissions were triaged as likely, possible or unlikely COVID-19 based on clinical criteria. Patients triaged as possible COVID-19 underwent FebriDx lateral flow assay on capillary blood, and those positive for myxovirus resistance protein A (a host response protein) were managed as likely COVID-19.Primary outcome measuresDiagnostic accuracy (sensitivity, specificity and predictive values) of the algorithm and the FebriDx assay using SARS-CoV-2 RT-PCR from nasopharyngeal swabs as the reference standard.Results4.0% (136) of 3443 medical admissions had RT-PCR confirmed COVID-19. Prevalence of COVID-19 was 46% (80/175) in those triaged as likely, 4.1% (50/1225) in possible and 0.3% (6/2033) in unlikely COVID-19. Using a SARS-CoV-2 RT-PCR reference standard, clinical triage had sensitivity of 96% (95% CI 91% to 98%) and specificity of 61.5% (95% CI 59.8% to 63.1%), while the triage algorithm including FebriDx had sensitivity of 93% (95% CI 87% to 96%) and specificity of 86.4% (95% CI 85.2% to 87.5%). While 2033 patients were deemed not to require isolation using clinical criteria alone, the addition of FebriDx to clinical triage allowed a further 826 patients to be released from isolation, reducing the need for isolation rooms by 9.5 per day, 95% CI 8.9 to 10.2. Ten patients missed by the algorithm had mild or asymptomatic COVID-19.ConclusionsA triage algorithm including the FebriDx assay had good sensitivity and was useful to ‘rule-out’ COVID-19 among medical admissions to hospital.

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Section: Strengths and Limitations Of This Studymentioning

confidence: 99%

Section: Ethics Approvalmentioning

confidence: 99%

Utility of the FebriDx point-of-care assay in supporting a triage algorithm for medical admissions with possible COVID-19: an observational cohort study

et al. 2021

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“…In one study, the platform had a sensitivity of 93% and a specificity of 86% 132 (with an estimated prevalence of 48% in the studied population). There are other studies available regarding this assay 133,134,135 but a comprehensive analysis of this platform escapes the purpose of our review. As the markers are commonly elevated for a range of pathogens, the test has a low specificity and has limited use in settings with low prevalence.…”

Section: Other Assaysmentioning

confidence: 99%

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17^th of August, 2021

Hawthorne

Harvey

2021

Preprint

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Point-of-care assays offer a decentralised and fast solution to the diagnosis of SARS-CoV-2 and provide benefits for patients, healthcare workers, healthcare facilities and other environments. This technology has to potential to prevent outbreaks, enable faster adoption of life-changing measures and improve hospitalar workflow. While reviews regarding the performance of those assays exist, a review focused on the real-life clinical performance and point-of-care feasibility of those platforms was missing. Therefore, the objective of this study is to help end users (clinicians, healthcare providers and organisations) to understand the real-life performance of point-of-care assays, aiding in their implementation in decentralised, true point-of-care facilities, or inside hospitals. 871 studies were screened in 3 major databases and 51 studies were included, evaluating 20 antigen tests and 10 nucleic-acid amplification platforms. We excluded studies that used processed samples, pre-selected populations, archived samples and laboratory-only evaluations and strongly favored prospective trial designs in our inclusion criteria. We also investigated package inserts, instructions for use, comments on published studies and manufacturers websites in order to assess feasibility of POC placement and additional information of relevance to the end user. Apart from sensitivity and specificity, we present information on time to results, hands-on time, kit storage, machine operating conditions and regulatory status. To the best of our knowledge, this is the first review to systematically evaluate POC test performance in real-life clinical practice. We found the performance of tests in clinical practice to be markedly different from the manufacturers reported performance and laboratory-only evaluations in the majority of studies. Our findings may help in the decision-making process related to SARS-CoV-2 test in real-life clinical settings.

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“…hospital [19–22]. We therefore developed and implemented a COVID-19 triage algorithm, supported by FebriDx, to inform patient flow from the ED whilst awaiting RT-PCR results.…”

Section: Introductionmentioning

confidence: 99%

Use of the FebriDx point-of-care assay as part of a triage algorithm for medical admissions with possible COVID-19

Houston

Gupta-Wright

Deas

et al. 2021

Preprint

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BackgroundPatients admitted to hospital with COVID-19 need rapid identification and isolation to prevent nosocomial transmission. However, isolation facilities are often limited, and SARS-CoV-2 RT-PCR results are often not available when discharged from the emergency department. We evaluated a triage algorithm to isolate patients with suspected COVID-19 using simple clinical criteria and the FebriDx assay.DesignRetrospective observational cohortSettingLarge acute care hospital in London, UKParticipantsAll medical admissions from the ED between 10th August 2020 and 4th November 2020 with valid SARS-CoV-2 RT-PCR.InterventionsMedical admissions were triaged as likely, possible or unlikely COVID-19 based on clinical criteria. Patients triaged as possible COVID-19 underwent FebriDx lateral flow assay on capillary blood, and those positive for MxA were managed as likely COVID-19.Primary Outcome measuresDiagnostic accuracy (sensitivity, specificity and predictive values) of the algorithm and the FebriDx assay compared to SARS-CoV-2 RT-PCR from nasopharyngeal swabs as the reference standard.Results4.0% (136/3,443) of medical admissions had RT-PCR confirmed COVID-19. Prevalence of COVID-19 was 45.7% (80/175) in those triaged as likely, 4.1% (50/1,225) in possible and 0.3% (6/2,033) in unlikely COVID-19. Compared to SARS-CoV-2 RT-PCR, clinical triage had sensitivity of 95.6% (95%CI: 90.5% - 98.0%) and specificity of 61.5% (95%CI: 59.8% - 63.1%), whilst the triage algorithm including FebriDx had sensitivity of 92.6% (95%CI: 86.8% - 96.0%) and specificity of 86.4% (95%CI: 85.2% - 87.5%). The triage algorithm reduced the need for 2,859 patients to be admitted to isolation rooms. Ten patients missed by the algorithm had mild or asymptomatic COVID-19.ConclusionsA triage algorithm including FebriDx assay had good sensitivity and was useful to ‘rule-out’ COVID-19 among medical admissions to hospital.STRENGTHS AND LIMITATIONS OF THIS STUDYPragmatic study including a large cohort of consecutive medical admissions providing routine clinical care.A single SARS-CoV-2 RT-PCR is an imperfect reference standard for COVID-19. Multiple RT-PCR platforms used, with different PCR targets and performance.A higher prevalence of COVID-19 or other respiratory pathogens might alter performance.Criteria for likely and possible COVID-19 groups changed subtly during the study period.

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Horses for courses? Assessing the potential value of a surrogate, point‐of‐care test for SARS‐CoV‐2 epidemic control

Cited by 8 publications

References 19 publications

Utility of the FebriDx point-of-care assay in supporting a triage algorithm for medical admissions with possible COVID-19: an observational cohort study

Utility of the FebriDx point-of-care assay in supporting a triage algorithm for medical admissions with possible COVID-19: an observational cohort study

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17^th of August, 2021

Use of the FebriDx point-of-care assay as part of a triage algorithm for medical admissions with possible COVID-19

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Horses for courses? Assessing the potential value of a surrogate, point‐of‐care test for SARS‐CoV‐2 epidemic control

Cited by 8 publications

References 19 publications

Utility of the FebriDx point-of-care assay in supporting a triage algorithm for medical admissions with possible COVID-19: an observational cohort study

Utility of the FebriDx point-of-care assay in supporting a triage algorithm for medical admissions with possible COVID-19: an observational cohort study

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17th of August, 2021

Use of the FebriDx point-of-care assay as part of a triage algorithm for medical admissions with possible COVID-19

Contact Info

Product

Resources

About

Field clinical performance of SARS-CoV-2 point-of-care diagnostic tests: a living systematic review of trials up to 17^th of August, 2021