Study Design and Patients
Patients presenting in the Hospital or ED of Kettering General Hospital,
a 600-bed acute care hospital in Kettering, England, with suspected
COVID-19 infection were prospectively screened for eligibility. Patients
were considered to be eligible if they were 16 years or older, met the
Public Health England (PHE) criteria for swab testing for COVID-19
including the requirement of hospital admission and having either
clinical or radiological evidence of pneumonia or acute respiratory
distress syndrome or influenza like illness (fever ≥37.8°C and at least
one of the following respiratory symptoms, which must be of acute onset:
persistent cough (with or without sputum), hoarseness, nasal discharge
or congestion, shortness of breath, sore throat, wheezing, sneezing), or
inpatients with new respiratory symptoms or fever without another cause
or worsening of a pre-existing respiratory
condition.32 Patients were not eligible if they did
not consent to participate, did not meet PHE criteria for COVID-19 swab
testing, received a live vaccine or antivirals in the last 14 days, had
respiratory symptoms for more than 7 days, or were taking
immunosuppressive therapy or systemic corticosteroids. Consent was
obtained from patients prior to inclusion in the study. The POC FebriDx
test was offered at the same time as the nasal and pharyngeal swab for
viral PCR testing (SARS-CoV-2, Influenza A, Influenza B and Respiratory
Syncytial Virus (RSV)). Standard routine blood tests (e.g. Complete
blood cell count (CBC), CRP, and procalcitonin (PCT)) were also
performed. SARS-CoV-2 rRT-PCR testing was repeated, based on
availability as tests were very limited early in the COVID-19 pandemic,
if there was strong clinical suspicion of COVID-19 infection and an
initial test was negative. Final disposition data was collected four
weeks after enrollment. Eligibility and workflow are summarized in
Figure 1.