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

Objective: To 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.

Design: Retrospective observational cohort.

Setting: Large acute National Health Service hospital in London, UK.

Participants: All medical admissions from the emergency department between 10 August 2020 and 4 November 2020 with a valid SARS-CoV-2 RT-PCR result.

Interventions: Medical 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 Measures: Diagnostic 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.

Results: 4.0% (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.

Conclusions: A triage algorithm including the FebriDx assay had good sensitivity and was useful to 'rule-out' COVID-19 among medical admissions to hospital.