Real-world performance of a single-use, analyser-free, molecular point-of-care test for COVID-19 used in the emergency department: results of a prospective trial (ED-POC)
Real-world performance of a single-use, analyser-free, molecular point-of-care test for COVID-19 used in the emergency department: results of a prospective trial (ED-POC)
Background: a novel single-use, analyser-free, molecular point-of-care test for SARS-CoV-2 (Veros COVID-19 test, Sherlock Biosciences) could reduce time to results and improve patient care and flow in the emergency department (ED), but its performance in this setting is unknown.
Methods: adults aged ≥18 years presenting to Southampton General Hospital (UK) with suspected COVID-19 were tested with the Veros COVID-19 test in addition to standard of care near-patient PCR. Measures of diagnostic accuracy were calculated for the Veros COVID-19 test stratified by Ct value. Discrepant results underwent viral culture.
Findings: between Jan 16 and May 2, 2023, 400 patients were enrolled with a median (IQR) age of 60 (34−77) and 141 (35·3%) were SARS-CoV-2 positive by PCR. The Veros test gave valid results on the first test in 384 (96·0%), and sensitivity and specificity were 127/141 (90·1%, 95%CI 83·9–94·5) and 258/259 (99·6%, 95%CI 97·9–100) overall. For those with high or moderate viral load (Ct ≤30), sensitivity was 125/129 (96·9%, 95%CI 92·3–99·2). One (7·1%) of 14 PCR positive/Veros test negative samples was culture positive. Median (IQR) time from sample collection to result was 19 (18−20) mins with the Veros test versus 73 (59−92) mins with PCR (p < 0·0001).
Interpretation: the Veros COVID-19 test generated results in near real-time, around 1 h sooner than rapid, near-patient, analyser-based PCR, and accuracy was excellent for samples with moderate and high viral loads. The Veros test represents a step-change in molecular diagnostics for infection and could significantly reduce time to results and improve patient management in EDs and other settings.
Acute respiratory illness, Analyser-free, COVID-19, Point-of-care testing, SARS-CoV-2
Chapman, Mary E.
ca9be874-fb36-48f7-bd62-b6ddeca35d4e
Brendish, Nathan J.
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Morris, Matthew
ef8a6da1-4efd-4b06-97ad-13baedb8ded7
Spalluto, C. Mirella
6802ad50-bc38-404f-9a19-40916425183b
McCormick, Christopher J.
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Moyses, Helen E.
56434d9c-870f-4539-a66a-c791add44f67
Clark, Tristan W.
712ec18e-613c-45df-a013-c8a22834e14f
14 September 2024
Chapman, Mary E.
ca9be874-fb36-48f7-bd62-b6ddeca35d4e
Brendish, Nathan J.
a8a4189e-01eb-4ab3-933e-a24cd188a4d7
Morris, Matthew
ef8a6da1-4efd-4b06-97ad-13baedb8ded7
Spalluto, C. Mirella
6802ad50-bc38-404f-9a19-40916425183b
McCormick, Christopher J.
0fce14bf-2f67-4d08-991f-114dd1e7f0bd
Moyses, Helen E.
56434d9c-870f-4539-a66a-c791add44f67
Clark, Tristan W.
712ec18e-613c-45df-a013-c8a22834e14f
Chapman, Mary E., Brendish, Nathan J., Morris, Matthew, Spalluto, C. Mirella, McCormick, Christopher J., Moyses, Helen E. and Clark, Tristan W.
(2024)
Real-world performance of a single-use, analyser-free, molecular point-of-care test for COVID-19 used in the emergency department: results of a prospective trial (ED-POC).
Journal of Infection, 89 (5), [106264].
(doi:10.1016/j.jinf.2024.106264).
Abstract
Background: a novel single-use, analyser-free, molecular point-of-care test for SARS-CoV-2 (Veros COVID-19 test, Sherlock Biosciences) could reduce time to results and improve patient care and flow in the emergency department (ED), but its performance in this setting is unknown.
Methods: adults aged ≥18 years presenting to Southampton General Hospital (UK) with suspected COVID-19 were tested with the Veros COVID-19 test in addition to standard of care near-patient PCR. Measures of diagnostic accuracy were calculated for the Veros COVID-19 test stratified by Ct value. Discrepant results underwent viral culture.
Findings: between Jan 16 and May 2, 2023, 400 patients were enrolled with a median (IQR) age of 60 (34−77) and 141 (35·3%) were SARS-CoV-2 positive by PCR. The Veros test gave valid results on the first test in 384 (96·0%), and sensitivity and specificity were 127/141 (90·1%, 95%CI 83·9–94·5) and 258/259 (99·6%, 95%CI 97·9–100) overall. For those with high or moderate viral load (Ct ≤30), sensitivity was 125/129 (96·9%, 95%CI 92·3–99·2). One (7·1%) of 14 PCR positive/Veros test negative samples was culture positive. Median (IQR) time from sample collection to result was 19 (18−20) mins with the Veros test versus 73 (59−92) mins with PCR (p < 0·0001).
Interpretation: the Veros COVID-19 test generated results in near real-time, around 1 h sooner than rapid, near-patient, analyser-based PCR, and accuracy was excellent for samples with moderate and high viral loads. The Veros test represents a step-change in molecular diagnostics for infection and could significantly reduce time to results and improve patient management in EDs and other settings.
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More information
Accepted/In Press date: 30 August 2024
e-pub ahead of print date: 5 September 2024
Published date: 14 September 2024
Additional Information:
We thank all the patients enrolled and all the clinical staff involved at Southampton General Hospital. We thank the directors, research nurses, data managers, clinical trials assistants, and laboratory staff at the National Institute for Health Research (NIHR) Southampton Clinical Research Facility, NIHR Southampton Biomedical Research Centre, and the R&D Department, at University Hospital Southampton NHS Foundation Trust. We also thank the NIHR Clinical Research Network, Wessex, for their support throughout the trial including part funding for MEC. NJB is supported by the NIHR Clinical Lecturer programme.
The Veros COVID-19 test kits were provided without cost by the manufacturer (Sherlock Biosciences, USA, formerly Sense Biodetection Limited). The manufacturer had no role in the study conception, design, data analysis, or manuscript preparation.
The views expressed in this publication are those of the authors and not necessarily those of the National Health Service (NHS), the NIHR, or the Department of Health and Social Care.
Keywords:
Acute respiratory illness, Analyser-free, COVID-19, Point-of-care testing, SARS-CoV-2
Identifiers
Local EPrints ID: 494731
URI: http://eprints.soton.ac.uk/id/eprint/494731
ISSN: 0163-4453
PURE UUID: e9c2ffcc-e8d9-4e5a-9e45-a82030ada36d
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Date deposited: 14 Oct 2024 17:06
Last modified: 14 Dec 2024 03:01
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Contributors
Author:
Mary E. Chapman
Author:
Matthew Morris
Author:
C. Mirella Spalluto
Author:
Helen E. Moyses
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