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.
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
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.
Text
1-s2.0-S0163445324001981-main
- Version of Record
More information
Accepted/In Press date: 30 August 2024
e-pub ahead of print date: 5 September 2024
Published date: 14 September 2024
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
Catalogue record
Date deposited: 14 Oct 2024 17:06
Last modified: 19 Oct 2024 02:00
Export record
Altmetrics
Contributors
Author:
Mary E. Chapman
Author:
Matthew Morris
Author:
C. Mirella Spalluto
Author:
Helen E. Moyses
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics