Background
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.
Methods
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).
Findings
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).
Interpretation
Our results suggest LFDs have promising performance characteristics for mass population testing and can be used to identify infectious positive individuals. The Innova LFD shows good viral antigen detection/sensitivity with excellent specificity, although kit failure rates and the impact of training are potential issues. These results support the expanded evaluation of LFDs, and assessment of greater access to testing on COVID-19 transmission.
Funding
Department of Health and Social Care. University of Oxford. Public Health England Porton Down, Manchester University NHS Foundation Trust, National Institute of Health Research.
(1) Adverse effects should be routinely reported. For the few studies that did report, adverse effects of spinal manipulation for all ages and conditions were rare, transient, and not severe. (2) Evidence from controlled studies and usual practice supports chiropractic care (the entire clinical encounter) as providing benefit to patients with asthma, cervicogenic vertigo, and infantile colic. Evidence was promising for potential benefit of manual procedures for children with otitis media and elderly patients with pneumonia. (3) The RCT design is not necessarily incompatible with WSR. RCTs could improve generalizability by basing protocols on usual practice. (4) Case reports could contribute more to WSR by increasing their emphasis on patient characteristics and patient-based outcomes. (5) Chiropractic investigators, practitioners, and funding agencies should increase their attention to observational designs.
CU were more likely than AO to drive over the .08 BAC driving limit (53% vs. 38%; p = .009) and after knowing they were too drunk to drive (57% vs. 44%; p = .025). CU were also more likely (56% vs. 35%; p = .000) to ride with an intoxicated driver while knowing it was unsafe. Conclusions/Importance: Combined-users are more likely to drive after drinking, drive while knowingly drunk, and participate in other high-risk behaviors such as heavy drinking that increase the potential for injury. Public policy makers and health professionals should focus prevention efforts to reduce high-risk combined-use behavior.
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