Researchers at the University of Southampton have reported that a low cost, instrument-free, disposable point-of-care test (POCT) can accurately diagnosis COVID-19.
FebriDx (Lumos diagnostics, Sarasota, Florida, US) is a CE-marked POCT that detects two host response proteins, Myxovirus resistance protein A and C reactive protein, in finger-prick blood samples, and is designed to distinguish viral from bacterial respiratory infection.
This real-world study examined the diagnostic accuracy of FebriDx in hospitalised patients during the first wave of the pandemic. FebriDx results were compared to the reference standard of SARS-CoV-2 polymerase chain reaction (PCR) on combined nose and throat swabs.
FebriDx was performed on 251 patients and gave a valid result in 248. A total of 118 of 248 (48%) were PCR positive for COVID-19.
FebriDx results were available after 10 minutes compared with 1.7 (95% CI, 1.6-2.1) hours with POCT using PCR and 23.4 (95% CI, 17.2-31.1) hours with laboratory PCR testing.
Sensitivity of FebriDx for the identification of COVID-19 was 93 per cent (95% CI, 87%-97%) and specificity was 86 per cent (95% CI, 79%-92%). Positive and negative likelihood ratios were 6.73 (95% CI, 4.37-10.37) and 0.08 (95% CI, 0.04-0.15), respectively.
In the multivariate model, age, sex and other clinical features did not contribute significantly to the effect of the FebriDx result in distinguishing patients with and without COVID-19.
Presenting the result in the Journal of Infection, the authors suggest FebriDx could be deployed in the NHS as a front door triage tool.