COVID-19: Rapid antigen detection for SARS-CoV-2 by lateral flow assay: A national systematic evaluation of sensitivity and specificity for mass-testing.

EClinicalMedicine
Tim E A Peto, UK COVID-19 Lateral Flow Oversight Team

Abstract

Lateral flow device (LFD) viral antigen immunoassays have been developed around the world as diagnostic tests for SARS-CoV-2 infection. They have been proposed to deliver an infrastructure-light, cost-economical solution giving results within half an hour. LFDs were initially reviewed by a Department of Health and Social Care team, part of the UK government, from which 64 were selected for further evaluation from 1st August to 15th December 2020. Standardised laboratory evaluations, and for those that met the published criteria, field testing in the Falcon-C19 research study and UK pilots were performed (UK COVID-19 testing centres, hospital, schools, armed forces). 4/64 LFDs so far have desirable performance characteristics (orient Gene, Deepblue, Abbott and Innova SARS-CoV-2 Antigen Rapid Qualitative Test). All these LFDs have a viral antigen detection of >90% at 100,000 RNA copies/ml. 8951 Innova LFD tests were performed with a kit failure rate of 5.6% (502/8951, 95% CI: 5.1-6.1), false positive rate of 0.32% (22/6954, 95% CI: 0.20-0.48). Viral antigen detection/sensitivity across the sampling cohort when performed by laboratory scientists was 78.8% (156/198, 95% CI 72.4-84.3). Our results suggest LFDs have promising perform...Continue Reading

References

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Citations

Jul 9, 2021·BMJ : British Medical Journal·Sian Taylor-Phillips, Jacqueline Dinnes
Jul 10, 2021·Journal of Medical Virology·Zakarya AbusrewilAdam Elzagheid
Jul 30, 2021·BMJ : British Medical Journal·Gareth Iacobucci
Sep 30, 2021·Journal of Primary Care & Community Health·Paraskevi GoggolidouTracy Warr
Nov 7, 2021·Emergency Medicine Journal : EMJ·Charles ReynardUNKNOWN CONDOR group
Oct 2, 2021·Journal of the Chinese Medical Association : JCMA·Yuan-Hung WangCheng-Chieh Chen
Nov 21, 2021·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Yusaku AkashiHiromichi Suzuki

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Software Mentioned

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