Abstract
Respiratory syncytial virus is a common cause of bronchiolitis. Historically, point-of-care tests have involved antigen detection technology with limited sensitivity. The aim of this study was to prospectively evaluate the diagnostic accuracy and model the economic impact of the Roche cobas® Liat® point-of-care influenza A/B and respiratory syncytial virus test.
The “DEC-RSV” study was a multi-centre, prospective, observational study in children under 2 years presenting with viral respiratory symptoms. A nasopharyngeal aspirate sample was tested using the point-of-care test and standard laboratory-based procedures. The primary outcome was accuracy of respiratory syncytial virus detection. The cost implications of adopting a point-of-care test were modelled using study data.
A total of 186 participants were recruited, with both tests performed on 177 samples. The point-of-care test was invalid for 16 samples (diagnostic yield 91%) leaving 161 available for primary analysis. After resolving discrepancies, the cobas® Liat® respiratory syncytial virus test had 100.00% (95% CI 96.07%–100.00%) sensitivity and 98.53% (95% CI 92.08%–99.96%) specificity. Median time to result was 0.6 h (interquartile range (IQR) 0.5–1) for point-of-care testing and 28.9 h (IQR 26.3–48.1) for standard laboratory testing. Estimated non-diagnostic cost savings for 1000 patients, based on isolation decision-making on point-of-care test result, were £57 010, which would increase to £94 847 when cohort nursing is used.
In young children the cobas® Liat® point-of-care respiratory syncytial virus test has high diagnostic accuracy using nasopharyngeal aspirates (currently an off-licence sample type). Time to result is clinically important and was favourable compared to laboratory-based testing. The potential exists for cost savings when adopting the point-of-care test.
Abstract
This prospective evaluation of the cobas Liat point-of-care RSV test in children demonstrated high diagnostic accuracy using nasopharyngeal aspirate samples, with favourable time to result compared to usual laboratory-based testing procedures https://bit.ly/2yKKmUB
Footnotes
This article has supplementary material available from openres.ersjournals.com.
Data collected for this study will be made available (in the form of any or all from the de-identified data on the study database, study protocol, statistical analysis plan and analytic code) to researchers who provide a methodologically sound research proposal, to assist with achievement of aims in the approved proposal. Data will be available from the time of publication of the article in print. Proposals should be directed to the corresponding author.
Support statement: Roche Diagnostics provided equipment and consumables, and funded the research costs. The study was performed and analysed independently by the National Institute for Health Research (NIHR) Newcastle In Vitro Diagnostics Co-operative. AJA, CL, JS, SG and AJS are funded by the NIHR Newcastle In Vitro Diagnostics Co-operative. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. MB was supported by a Medical Research Council Clinician Scientist Fellowship (MR/M008797/1). Funding information for this article has been deposited with the Crossref Funder Registry.
Conflict of interest: A.J. Allen has nothing to declare.
Conflict of interest: A. Gonzalez-Ciscar has nothing to declare.
Conflict of interest: C. Lendrem has nothing to declare.
Conflict of interest: J. Suklan has nothing to declare.
Conflict of interest: K. Allen has nothing to declare.
Conflict of interest: A. Bell has nothing to declare.
Conflict of interest: F. Baxter has nothing to declare.
Conflict of interest: S. Crulley has nothing to declare.
Conflict of interest: L. Fairlie has nothing to declare.
Conflict of interest: D. Hardy has nothing to declare.
Conflict of interest: L. Johnston has nothing to declare.
Conflict of interest: J. McKenna has nothing to declare.
Conflict of interest: N. Richards has nothing to declare.
Conflict of interest: G. Shovlin has nothing to declare.
Conflict of interest: C. Simmister has nothing to declare.
Conflict of interest: S. Waugh has nothing to declare.
Conflict of interest: P. Woodsford has nothing to declare.
Conflict of interest: S. Graziadio has nothing to declare.
Conflict of interest: M. Power has nothing to declare.
Conflict of interest: A.J. Simpson has nothing to declare.
Conflict of interest: P. Kumar has nothing to declare.
Conflict of interest: K. Eastham has nothing to declare.
Conflict of interest: M. Brodlie reports grants and speaker fees paid to Newcastle University from Roche Diagnostics during the conduct of the study; and grants from Pfizer, speaker fees paid to Newcastle University from Novartis and TEVA, and travel expenses for educational meetings from Boehringer Ingelheim and Vertex Pharmaceuticals, outside the submitted work.
- Received January 13, 2020.
- Accepted May 22, 2020.
- Copyright ©ERS 2020
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