Post by Nadica (She/Her) on Sept 10, 2024 2:42:28 GMT
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) - Published Sept 5, 2024
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 20minutes, around 1hour faster than rapid PCR.
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 1hour 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.
Funding
Sherlock Biosciences
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 20minutes, around 1hour faster than rapid PCR.
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 1hour 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.
Funding
Sherlock Biosciences