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) - 17/10/24
, Matthew Morris a, C. Mirella Spalluto a, c, Christopher J. McCormick c, Helen E. Moyses a, Tristan W. Clark a, b, c
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Summary |
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.
Le texte complet de cet article est disponible en PDF.Highlights |
• | Veros COVID-19 is a handheld, single-use, molecular test for COVID-19. |
• | Performance was compared to rapid PCR in 400 patients in the Emergency Department. |
• | Veros COVID-19′s sensitivity was 90.1% and specificity was 99.6%. |
• | In patients with moderate or high viral loads, sensitivity was 96.9%. |
• | Veros returned results in under 20 min, around 1 h faster than rapid PCR. |
Keywords : Point-of-care testing, COVID-19, SARS-CoV-2, Analyser-free, Acute respiratory illness
Plan
Vol 89 - N° 5
Article 106264- novembre 2024 Retour au numéro
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