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.