Abstract
ObjectivesTo determine the negative predictive value (NPV) of the FebriDx point-of-care host response device in patients presenting with symptoms suggestive of COVID-19 infection in a mostly immunised Australian emergency department (ED) population during the late 2021 phase of the COVID-19 pandemic.DesignObservational diagnostic accuracy study comparing FebriDx point-of-care test to SARS-CoV-2 PCR.SettingAn ED in Melbourne, Australia, with 63 000 annual presentations in 2021.ParticipantsPatients aged 16 and over who met the Victorian Department of Health case definition for suspected COVID-19 infection PCR testing. Patients meeting any of the following criteria were excluded: <16 years of age; acute respiratory symptom(s) with onset>14 days prior to testing; current immunosuppressive or interferon therapy; live immunisation within the last 30 days; fever lasting>7 days; antibiotic or antiviral use in the preceding 14 days; experience of major trauma, major surgical intervention or severe burns within the last 30 days.Primary and secondary outcome measuresCOVID-19 PCR results (detected, not detected) and FebriDx results (bacterial positive, viral negative, viral positive).Results94 participants were enrolled (female: 46; male: 48), 34% of participants (tested positive for COVID-19 according to PCR results, with a background incidence among all adult ED attenders of 2.5%. The sensitivity of FebriDx for detection of COVID-19 was 56% (95% CI 40% to 100%) and specificity was 92% (95% CI 84% to 100%). For the population tested, this resulted in an NPV of 80% (95% CI 71% to 100%) and a positive predictive value of 78% (95% CI 60% to 100%).ConclusionsIn the context of a population with low COVID-19 infection rates, an evolved variant of COVID-19 and a very high community COVID-19 vaccination rate, FebriDx demonstrated reduced sensitivity and NPV relative to results from earlier international tests. These contextual factors should be considered during any attempt to generalise the current results.Trial registration numberACTRN12620001029987 (Australian Clinical Trials).
Funder
Planet Innovation Pty Ltd, Australia
Reference20 articles.
1. Bond K , Smith B , Gardiner E . Utility of SARS-CoV-2 rapid antigen testing for patient triage in the emergency department: a clinical implementation study in Melbourne, Australia SSRN; 2022. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4024202 [Accessed 18 Mar 2022].
2. Multi-site assessment of rapid, point-of-care antigen testing for the diagnosis of SARS-CoV-2 infection in a low-prevalence setting: a validation and implementation study;Muhi;Lancet Reg Health West Pac,2021
3. Dinnes J , Deeks JJ , Berhane S , et al . Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection. Cochrane Database Syst Rev 2021.doi:10.1002/14651858.CD013705.pub2
4. Lumos Diagnostics . New study highlights the utility of the FebriDx® test for rapid triage and identification of COVID-19, 2020. Available: https://lumosdiagnostics.com/news/new-study-highlights-the-utility-of-the-febridx-text-for-rapid-triage-and-identification-of-covid-19/ [Accessed 18 Mar 2022].
5. Diagnosis of Viral Infections Using Myxovirus Resistance Protein A (MxA)
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献