Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

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Abstract

Annual influenza epidemics cause substantial morbidity and mortality, and the majority of patients with influenza-like illness present to primary care. Point-of-care influenza tests could support treatment decisions. It is critical to establish analytic performance of these platforms in real-life patient samples before uptake can be considered. We aimed to assess the analytical performance and ease of use of the cobas® Liat® PCR POCT in detecting influenza A/B and RSV in samples collected from patients with influenza-like illness in primary care. Sensitivity and specificity of the cobas® Liat® POCT are calculated in comparison with a commercial laboratory-based PCR test (Fast-Track Respiratory Pathogens 21 Plus kit (Fast-Track Diagnostics)). Samples with discordant results were analysed additionally by the RespiFinder 2Smart (PathoFinder) using an Extended Gold Standard (EGS). Acceptability was scored on a five-point Likert scale as well as a failure mode analysis of the cobas® Liat® POCT was performed. Nasal and oropharyngeal swabs were obtained from 140 children and nasopharyngeal swabs from 604 adults (744 patients). The cobas® Liat® POCT had a sensitivity and specificity of 100% (95% CI 99–100%) and 98.1% (95%CI 96.3–99%) for influenza A, 100% (95% CI 97.7–100%) and 99.7% (95%CI 98.7–99.9%) for influenza B and 100% (95% CI 87.1–100%) and 99.4% (95%CI 98.6–99.8%) for RSV, respectively. According to trained lab technicians, the cobas® Liat® POCT was considered easy-to-use, with a fast turn-around-time. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance. Point-of-care influenza tests could support treatment decisions in primary care. Cobas® Liat® POCT is a promising decentralised test platform for influenza A/B and RSV in primary care as it provides fairly rapid results with excellent analytic performance.

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FMEA: a model for reducing medical errors.

Maria Laura Chiozza, Clemente Ponzetti (2009)

Patient safety is a management issue, in view of the fact that clinical risk management has become an important part of hospital management. Failure Mode and Effect Analysis (FMEA) is a proactive technique for error detection and reduction, firstly introduced within the aerospace industry in the 1960s. Early applications in the health care industry dating back to the 1990s included critical systems in the development and manufacture of drugs and in the prevention of medication errors in hospitals. In 2008, the Technical Committee of the International Organization for Standardization (ISO), licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. Here we describe the main steps of the FMEA process and review data available on the application of this technique to laboratory medicine. A significant reduction of the risk priority number (RPN) was obtained when applying FMEA to blood cross-matching, to clinical chemistry analytes, as well as to point-of-care testing (POCT).

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Multi-center evaluation of the cobas ® Liat ® Influenza A/B & RSV assay for rapid point of care diagnosis

Jane Gibson, Elissa Schechter-Perkins, Patricia Mitchell … (2017)

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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Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial

Jan Verbakel, Marieke B Lemiengre, Tine De Burghgraeve … (2016)

Background Point-of-care blood C-reactive protein (CRP) testing has diagnostic value in helping clinicians rule out the possibility of serious infection. We investigated whether it should be offered to all acutely ill children in primary care or restricted to those identified as at risk on clinical assessment. Methods Cluster randomised controlled trial involving acutely ill children presenting to 133 general practitioners (GPs) at 78 GP practices in Belgium. Practices were randomised to undertake point-of-care CRP testing in all children (1730 episodes) or restricted to children identified as at clinical risk (1417 episodes). Clinical risk was assessed by a validated clinical decision rule (presence of one of breathlessness, temperature ≥ 40 °C, diarrhoea and age 12–30 months, or clinician concern). The main trial outcome was hospital admission with serious infection within 5 days. No specific guidance was given to GPs on interpreting CRP levels but diagnostic performance is reported at 5, 20, 80 and 200 mg/L. Results Restricting CRP testing to those identified as at clinical risk substantially reduced the number of children tested by 79.9 % (95 % CI, 77.8–82.0 %). There was no significant difference between arms in the number of children with serious infection who were referred to hospital immediately (0.16 % vs. 0.14 %, P = 0.88). Only one child with a CRP < 5 mg/L had an illness requiring admission (a child with viral gastroenteritis admitted for rehydration). However, of the 80 children referred to hospital to rule out serious infection, 24 (30.7 %, 95 % CI, 19.6–45.6 %) had a CRP < 5 mg/L. Conclusions CRP testing should be restricted to children at higher risk after clinical assessment. A CRP < 5 mg/L rules out serious infection and could be used by GPs to avoid unnecessary hospital referrals. Trial registration ClinicalTrials.gov Identifier: NCT02024282 (registered on 14th September 2012).

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Author and article information

Contributors

Jan Y Verbakel: jan.verbakel@phc.ox.ac.uk

Journal

Journal ID (nlm-ta): Eur J Clin Microbiol Infect Dis

Journal ID (iso-abbrev): Eur. J. Clin. Microbiol. Infect. Dis

Title: European Journal of Clinical Microbiology & Infectious Diseases

Publisher: Springer Berlin Heidelberg (Berlin/Heidelberg )

ISSN (Print): 0934-9723

ISSN (Electronic): 1435-4373

Publication date (Electronic): 14 March 2020

Publication date PMC-release: 14 March 2020

Publication date (Print): 2020

Volume: 39

Issue: 8

Pages: 1453-1460

Affiliations

[1 ]GRID grid.4991.5, ISNI 0000 0004 1936 8948, NIHR Community Healthcare MIC, Nuffield Department of Primary Care Health Sciences, , University of Oxford, ; Woodstock Road, Oxford, Oxfordshire OX26GG UK

[2 ]GRID grid.5596.f, ISNI 0000 0001 0668 7884, Department of Public Health and Primary Care, , KU Leuven, ; Kapucijnenvoer 33, 3000 Leuven, Belgium

[3 ]GRID grid.4991.5, ISNI 0000 0004 1936 8948, Nuffield Department of Primary Care Health Sciences, , University of Oxford, ; Woodstock Road, Oxford, Oxfordshire OX26GG UK

[4 ]GRID grid.411414.5, ISNI 0000 0004 0626 3418, Laboratory of Clinical Microbiology, , Antwerp University Hospital, ; Edegem, Belgium

[5 ]GRID grid.5284.b, ISNI 0000 0001 0790 3681, Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), , University of Antwerp, ; Antwerp, Belgium

Article

Publisher ID: 3860

DOI: 10.1007/s10096-020-03860-5

PMC ID: 7343728

PubMed ID: 32172369

SO-VID: 5138359f-15cd-48b9-8a73-847f05f6f737

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Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 8 January 2020

Date accepted : 4 March 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004963, Seventh Framework Programme;

Award ID: HEALTH-F3-2013-602525

Award Recipient : Christopher C Butler

Funded by: Roche Molecular Diagnostics

Award ID: LIAT-IIS-007

Award Recipient : Christopher C Butler

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: influenza,point-of-care,primary care,ease-of-use,pcr

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: influenza, point-of-care, primary care, ease-of-use, pcr

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Performance and ease of use of a molecular point-of-care test for influenza A/B and RSV in patients presenting to primary care

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Most cited references 14

FMEA: a model for reducing medical errors.

Multi-center evaluation of the cobas ® Liat ® Influenza A/B & RSV assay for rapid point of care diagnosis

Should all acutely ill children in primary care be tested with point-of-care CRP: a cluster randomised trial

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Cited by 6

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