Objectives The Coronavirus disease 2019 (COVID‐19) pandemic is straining healthcare resources. Molecular testing turnaround time precludes having results at the point‐of‐care (POC) thereby exposing COVID‐19/Non‐COVID‐19 patients while awaiting diagnosis. We evaluated the utility of a triage strategy including FebriDx, a 10‐minute POC finger‐stick blood test that differentiates viral from bacterial acute respiratory infection through detection of Myxovirus‐resistance protein A (MxA) and C‐reactive protein (CRP), to rapidly isolate viral cases requiring confirmatory testing. Methods This observational, prospective, single‐center study enrolled patients presenting to/within an acute care hospital in England with suspected COVID‐19 between March and April 2020. Immunocompetent patients ≥16 years requiring hospitalisation with pneumonia or acute respiratory distress syndrome or influenza‐like illness (fever and ≥1 respiratory symptom within 7 days of enrolment, or inpatients with new respiratory symptoms, fever of unknown cause or pre‐existing respiratory condition worsening). The primary endpoint was diagnostic performance of FebriDx to identify COVID‐19 as a viral infection; secondary endpoint was SARS‐CoV‐2 molecular test diagnostic performance compared with the reference standard COVID‐19 Case Definition (molecular or antibody detection of SARS‐CoV‐2). Results Valid results were available for 47 patients. By reference standard, 35 had viral infections (34/35 COVID‐19; 1/35 non‐COVID‐19; overall FebriDx viral sensitivity 97.1% (95%CI 83.3‐99.9)). Of the COVID‐19 cases, 34/34 were FebriDx viral positive (sensitivity 100%; 95%CI 87.4‐100); 29/34 had an initial SARS‐CoV‐2 positive molecular test (sensitivity 85.3%; 95%CI 68.2‐94.5). FebriDx was viral negative when the diagnosis was not COVID‐19 and SARS‐Cov‐2 molecular test was negative (negative predictive value (NPV) 100% (13/13; 95%CI 71.7‐100)) exceeding initial SARS‐CoV‐2 molecular test NPV 72.2% (13/19; 95%CI 46.4‐89.3). The diagnostic specificity of FebriDx and initial SARS‐CoV‐2 molecular test was 100% (13/13; 95%CI 70‐100 and 13/13; 95%CI 85.4‐100, respectively). Conclusions FebriDx could be deployed as part of a reliable triage strategy for identifying symptomatic cases as possible COVID‐19 in the pandemic.

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Background Reliable differentiation between uncomplicated and self-limiting acute respiratory tract infections (ARIs) and more severe bacterial respiratory tract infections remains challenging, due to the non-specific clinical manifestations in both systemic bacterial or viral infections. The current COVID-19 pandemic is putting extraordinary strain on healthcare resources. To date, molecular testing is available but has a long turnaround time and therefore cannot provide results at the point-of-care, leading to a delay in results thereby exposing patients to cross-infection and delay in diagnosis (1-3). Methods We prospectively evaluated the utility of FebriDx®, a point-of-care fingerstick blood test that can differentiate viral from bacterial ARIs through simultaneous detection of both Myxovirus-resistance protein A (MxA) and C-reactive protein (CRP), in rapidly determining viral cases requiring immediate isolation and confirmatory molecular testing, from non-infectious patients or bacterial infections that require antibacterial therapy.Results 75 consecutive patients were assessed and 48 eligible cases were tested with FebriDx®. Overall, 35 patients had FebriDx® test viral positive. All 35 patients had either positive rt-PCR (n=30) for COVID-19 or clinical picture highly suggestive of COVID-19 infection (PPV of 100% in a pandemic situation)[AB1] . In the 13 cases it was viral negative, rRT-PCR was also negative in all cases. In one case of LRTI, it was not possible to determine the exact cause of infection and a viral infection couldn’t be excluded. Including this patient, the NPV was 12/13 (92%) exceeding the NPV of rRt-PCR at 71% (12/17). Sensitivity was conservatively calculated at 97% (35/36) compared to 85.7% (30[RS2] /35) for rRt-PCR. Similarly the specificity of both FebriDx®and rRt-PCR was 100% (12/12).Conclusions In the current COVID-19, FebriDx® shows potential as a reliable POC test and a proxy marker of COVID-19 infection amongst inpatients in a secondary care setting. [AB1]35/35 equates to a sensitivity and specificity of 100% for COVID, would you be willing to say that instead of ‘near 100% ppv)? [RS2]I believe PCR was 85.7% (30/35), because PCR only detects the COVID cases

Background Differentiating viral from bacterial acute respiratory infections (ARIs) remains challenging, due to the non-specific clinical manifestations. The COVID-19 pandemic is putting extraordinary strain on healthcare resources. To date, molecular testing is available but has a long turnaround time and therefore cannot provide results at the point-of-care (POC) thereby exposing COVID-19/Non-COVID-19 patients to each other while awaiting diagnosis. Methods This observational study prospectively evaluated the utility of a triage strategy including FebriDx, a POC fingerstick blood test that differentiates viral from bacterial ARIs through simultaneous detection of Myxovirus-resistance protein A (MxA) and C-reactive protein (CRP), in rapidly determining viral cases requiring immediate isolation and confirmatory molecular testing, from non-infectious patients or bacterial infections requiring antibiotics. Results 75 consecutive patients were screened, 48 eligible cases were tested with FebriDx, 36 were confirmed viral infection and 35/36 had COVID-19. 31/35 COVID-19 cases tested positive for SARS-CoV-2 via rRT-PCR and (4/35) had a clinical diagnosis of probable COVID-19 based on symptoms, epidemiological history, and chest imaging (PPV 100% (35/35)). 13 cases were FebriDx viral negative and rRT-PCR was also negative. In one case, it was not possible to determine the exact cause of infection, although a viral infection could not be excluded. Including this patient, FebriDx NPV was 92.3% (12/13), exceeding the NPV of rRT-PCR a 68.3% (13/19), and diagnostic sensitivity was conservatively calculated at 97% (35/36) compared to 82.9% (29/35) for initial rRT-PCR. The diagnostic specificity of both FebriDx and rRT-PCR was 100%. Conclusions: FebriDx could be deployed as part of a reliable triage strategy for identifying possible COVID-19 patients with symptomatic ARI in the COVID-19 pandemic. Key words: Pandemic; COVID-19; SARS-CoV-2; pneumonia; viral; point of care; infection Utility of the FebriDx point-of-care test for rapid triage and identification of possible coronavirus disease 2019 (COVID-19

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