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Hospital Healthcare Europe

Introducing FebriDx®: A Rapid, Front Door Triage Test for the Pandemic

Diagnosing and cohorting suspected COVID-19 patients in the Emergency Department (ED) remains a challenge because of the long turnaround times of SARS CoV-2 PCR testing 1,2 and the need to repeat tests due to false negative results3. Consequently, COVID-19 negative patients are exposed to positive patients leading to spread of infection. The situation is further compounded by the limited availability of single isolation units, meaning that patients are temporarily held in assessment areas or inpatient wards until results are available. Rapid antigen tests are available for SARS-CoV- 2 and whilst rapid and easy to use, their performance in a real-world setting has been shown to be only 23% to 30% sensitive.4,5

A rapid and accurate solution is available with proven clinical data from two UK prospective studies. FebriDx is the first and only rapid POC test to differentiate a viral from bacterial acute respiratory infection (ARI)6.7 through the simultaneous detection of both Myxovirus resistance protein A (MxA)8.9,10, a specific viral biomarker and C-reactive protein (CRP) directly from a fingerstick blood sample in just 10 minutes. FebriDx® can rapidly triage and cohort COVID-19 positive patients from negative patients, reducing risk of transmission and improving clinic workflow.

Two UK hospital studies have shown FebriDx® to be highly accurate in detecting COVID-19 infections and identifying infections missed by RT-PCR. Clark et al.11 concluded that FebriDx® can enable effective triaging, so viral negative patients can be rapidly cohorted in non-COVID-19 areas allowing viral positive patients to be immediately isolated whilst awaiting confirmatory testing. FebriDx was shown to be 93% (110/118) sensitive for identification of COVID-19 infections compared to PCR with results being available in 10 minutes compared to 23.4 hours for lab PCR testing. Several patients with FebriDx viral positive results (negative by PCR) had classical radiological features of COVID-19, thus were likely to be true positives despite negative PCR results.12  FebriDx NPV was calculated to be 99% both at 20% and 10% COVID-19 prevalence, concluding that a negative FebriDx will be a useful rule-out test.

Karim et al.13 showed that FebriDx® was 100% sensitive (34/34) for identifying COVID-19 infections compared to 85.3% (29/34) for RT-PCR initial testing. FebriDx provided results in 10 minutes whilst the SARS-CoV-2 RT-PCR had a 48-hour turnaround time. The use of FebriDx as an initial triage test may have prevented COVID-19 negative patients being exposed to COVID-19 positive patients caused by the delay in molecular test results. During viral pandemics it is also imperative to ensure that patients with bacterial infections are not missed. In the study FebriDx® identified 100% (8/8) of bacterial infections in patients shown to be negative for COVID-19.

FebriDx® can benefit EDs and other healthcare settings overcoming the limitations of lab-based PCR tests and will have even greater utility in the forthcoming influenza season where the ability to cohort viral positive from viral negative patients and streamline confirmatory testing will be even greater. FebriDx can be rapidly deployed as a front door triage tool in hospitals and urgent care centres to overcome current issues of delayed diagnosis from PCR testing.11,13

FebriDx allows clinicians to:

  • Rapidly identify viral patients.
  • Facilitate immediate patient isolation.
  • Ensure patients with bacterial infections are not missed.
  • Rule out non-clinically significant infection.
  • Improve Clinic workflow
  • Reduce Healthcare costs

References:

  1. Public Health England (PHE). Coronavirus (COVID-19): getting tested. April 15, 2020. Accessed on July 14, 2020.
  2. Devine, C., Covid-19 testing: A spike in demand, a delay on results, in CNN. July 7, 2020. Accessed on July 22, 2020.
  3. Kucirka, L. M. et al. 2020. Variation in False-Negative Rate of Reverse Transcriptase Polymerase Chain Reaction–Based SARS-CoV-2 Tests by Time Since Exposure, Annals of Internal Medicine.
  4. Scohy, A. et al. 2020. Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis, Journal of Clinical Virology: 104455.
  5. Blairon, L. et al.2020. Implementation of rapid SARS-CoV- 2 antigenic testing in a laboratory without access to molecular methods: experiences of a general hospital, Journal of Clinical Virology: 104472.
  6. Shapiro, N. et al. 2018. A prospective, multi-centre US clinical trial to determine accuracy of FebriDx® point-of-care testing for acute upper respiratory infections with and without a confirmed fever, Annals of Medicine, 50: 420-29.
  7. Self, W. et al. 2017. Diagnostic accuracy of FebriDx®: a rapid test to detect immune responses to viral and bacterial upper respiratory infections, Journal of clinical medicine, 6: 94.
  8. Engelmann, I. et al. (2015). Diagnosis of viral infections using myxovirus resistance protein A (MxA). Pediatrics, 135(4), e985-e993.
  9. Joseph, P. and Godofsky, E. 2018. Outpatient antibiotic stewardship: a growing frontier—combining myxovirus resistance protein a with other biomarkers to improve antibiotic use. In Open forum infectious diseases. Oxford University Press US.
  10. Nakabayashi, M. et al. 2006. MxA-based recognition of viral illness in febrile children by a whole blood assay. Pediatric research, 60: 770-74.
  11. Clark, T. W. et al. 2020. Diagnostic accuracy of the FebriDx® host response point-of-care test in patients hospitalised with suspected COVID-19, Journal of Infection.
  12. The European Centers for Disease Prevention and Control (ECDC). Case definition for coronavirus disease 2019 (COVID-19), as of 29 May 2020.
  13. Karim, N. et al. 2020. Utility of FebriDx® in early identification of possible COVID19 infection.

Contact information:

John Wisson
Lumos Diagnostics
john.wisson@lumosdiagnostics.com
www.FebriDx.com

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