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      Implementation of the cobas Liat influenza point-of-care test into an emergency department during a high-incidence season: a retrospective evaluation following real-world implementation

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          Summary

          The cobas Liat influenza A/B and respiratory syncytial virus (RSV) assay (Liat) was used in the adult emergency department of a large London hospital from 21 st January 2018 to 14 th April 2018. Influenza was detected in 308 of 1027 (30%) samples tested; influenza A in 157 (15.3%), influenza B in 149 (14.5%) and RSV in 28 (2.7%). When compared against Fast Track Diagnostics Respiratory Pathogens 21 multiplex polymerase chain reaction and Cepheid Xpert Xpress Flu/RSV assay, Liat performance for the detection of influenza A or B was: sensitivity 85% [95% confidence interval (CI) 76–92)], specificity 98% (95% CI 97–99), negative predictive value 94% (95% CI 92–96) and positive predictive value 95% (95% CI 91–97).

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          Most cited references7

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          Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial

          Summary Background Respiratory virus infection is a common cause of hospitalisation in adults. Rapid point-of-care testing (POCT) for respiratory viruses might improve clinical care by reducing unnecessary antibiotic use, shortening length of hospital stay, improving influenza detection and treatment, and rationalising isolation facility use; however, insufficient evidence exists to support its use over standard clinical care. We aimed to assess the effect of routine POCT on a broad range of clinical outcomes including antibiotic use. Methods In this pragmatic, parallel-group, open-label, randomised controlled trial, we enrolled adults (aged ≥18 years) within 24 h of presenting to the emergency department or acute medical unit of a large UK hospital with acute respiratory illness or fever higher than 37·5°C (≤7 days duration), or both, over two winter seasons. Patients were randomly assigned (1:1), via an internet-based allocation sequence with random permuted blocks, to have a molecular POC test for respiratory viruses or routine clinical care. The primary outcome was the proportion of patients who received antibiotics while hospitalised (up to 30 days). Secondary outcomes included duration of antibiotics, proportion of patients receiving single doses or brief courses of antibiotics, length of stay, antiviral use, isolation facility use, and safety. Analysis was by modified intention to treat, excluding patients who declined intervention or were withdrawn for protocol violations. This study is registered with ISRCTN, number 90211642, and has been completed. Findings Between Jan 15, 2015, and April 30, 2015, and between Oct 1, 2015, and April 30, 2016, we enrolled 720 patients (362 assigned to POCT and 358 to routine care). Six patients withdrew or had protocol violations. 301 (84%) of 360 patients in the POCT group received antibiotics compared with 294 (83%) of 354 controls (difference 0·6%, 95% CI −4·9 to 6·0; p=0·84). Mean duration of antibiotics did not differ between groups (7·2 days [SD 5·1] in the POCT group vs 7·7 days [4·9] in the control group; difference −0·4, 95% CI −1·2 to 0·4; p=0·32). 50 (17%) of 301 patients treated with antibiotics in the POCT group received single doses or brief courses of antibiotics (<48 h) compared with 26 (9%) of 294 patients in the control group (difference 7·8%, 95% CI 2·5 to 13·1; p=0·0047; number needed to test=13). Mean length of stay was shorter in the POCT group (5·7 days [SD 6·3]) than in the control group (6·8 days [7·7]; difference −1·1, 95% CI −2·2 to −0·3; p=0·0443). Appropriate antiviral treatment of influenza-positive patients was more common in the POCT group (52 [91%] of 57 patients) than in the control group (24 [65%] of 37 patients; difference 26·4%, 95% CI 9·6 to 43·2; p=0·0026; number needed to test=4). We found no differences in adverse outcomes between the groups (77 [21%] of 360 patients in the POCT group vs 88 [25%] of 354 patients in the control group; −3·5%, −9·7 to 2·7; p=0·29). Interpretation Routine use of molecular POCT for respiratory viruses did not reduce the proportion of patients treated with antibiotics. However, the primary outcome measure failed to capture differences in antibiotic use because many patients were started on antibiotics before the results of POCT could be made available. Although POCT was not associated with a reduction in the duration of antibiotics overall, more patients in the POCT group received single doses or brief courses of antibiotics than did patients in the control group. POCT was also associated with a reduced length of stay and improved influenza detection and antiviral use, and appeared to be safe. Funding University of Southampton.
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            Multi-center evaluation of the cobas ® Liat ® Influenza A/B & RSV assay for rapid point of care diagnosis

            Point of Care Testing (POCT) provides the capability for rapid laboratory test results in patient care environments where a traditional clinical laboratory is not available. POCTs have shorter turn-around times (TATs), they may be performed by non-laboratory personnel, and the need for transport time is eliminated. The Food and Drug Administration (FDA) recently granted Clinical Laboratory Improvements Amendment (CLIA) waiver status to the cobas® Influenza A/B & RSV assay, a rapid, accurate point-of-care test for Influenza and respiratory syncytial virus (RSV) performed on the Liat® System. The performance characteristics of this test were determined though a multi-site study consisting of different point of care testing environments. Prospectively collected Nasopharyngeal (NP) swabs from 1361 patients seen at 8 primary care clinics and 4 emergency departments (EDs) and 295 retrospectively identified specimens were tested for Influenza A/B and RSV on the cobas® Liat® platform. Performance characteristics were determined through comparison to ProFlu+, a laboratory-based PCR test for Influenza A/B and RSV (reference test). Discordant specimens were adjudicated following bi-directional sequencing. The cobas® Influenza A/B and RSV assay showed sensitivities of 99.6%, 99.3%, and 96.8% for Influenza A, Influenza B, and RSV, respectively as determined from percent positive agreement (PPA) following comparison to the reference test. Sequencing confirmed cobas® Influenza A/B and RSV results in 49.2% of reference test discordant specimens, while crossing threshold data suggest increased sensitivity compared to the reference test. The cobas® Influenza A/B and RSV assay was found to be a rapid, sensitive POCT for the detection of these viruses, and provides laboratory-quality PCR-based diagnostic results in point of care settings.
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              Diagnosis, management and outcomes of adults hospitalized with influenza.

              Annual influenza epidemics and periodic pandemics result in excess hospital admissions. Hospitalization typically occurs in those with underlying medical conditions, those at the extremes of age and in pregnant woman; young adults and obese individuals were also at increased risk during the 2009 H1N1 pandemic. Severe influenza pneumonia, exacerbation of underlying lung diseases, cardiovascular and cerebrovascular events and bacterial superinfection are common reasons for hospitalization. Clinical diagnosis is unreliable and virological confirmation can be challenging. Overall mortality among adults hospitalized with influenza ranges from 4% to 8%, although higher mortality (>10-15%) may be seen during pandemics and among the immunocompromised. Recent data have suggested that neuraminidase inhibitors, particularly when given early, can accelerate viral clearance and improve clinical outcomes in hospitalized adults; thus, antiviral treatment should be considered in all cases. Controlled clinical trials are urgently needed in this population to evaluate comparative treatment efficacy of different agents and combinations, including emergence of antiviral resistance, and to address issues related to dosage, duration and parenteral route.
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                Author and article information

                Contributors
                Journal
                J Hosp Infect
                J. Hosp. Infect
                The Journal of Hospital Infection
                Published by Elsevier Ltd on behalf of The Healthcare Infection Society.
                0195-6701
                1532-2939
                16 December 2018
                March 2019
                16 December 2018
                : 101
                : 3
                : 285-288
                Affiliations
                [a ]Infection Care Group, St George's University Hospitals NHS Foundation Trust, London, UK
                [b ]Department of Emergency Medicine, St George's University Hospitals NHS Foundation Trust, London, UK
                [c ]Department of Microbiology, East Kent Hospitals University NHS Foundation Trust, Ashford, UK
                [d ]Institute of Infection, St George's University of London, London, UK
                Author notes
                []Corresponding author. Address: Department of Infection, St George's University Hospitals NHS Foundation Trust, Blackshaw Road, London SW17 0QT, UK. youngs.jonathan@ 123456gmail.com
                Article
                S0195-6701(18)30712-6
                10.1016/j.jhin.2018.12.008
                7124296
                30562558
                174330dd-0b12-4d12-af61-58bdb19d28b4
                © 2018 Published by Elsevier Ltd on behalf of The Healthcare Infection Society.

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                : 30 October 2018
                : 11 December 2018
                Categories
                Article

                Infectious disease & Microbiology
                influenza virus a,influenza virus b,infection control,point-of-care technology,rapid diagnostic tests,polymerase chain reaction

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