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Accuracy of the mologic COVID-19 rapid antigen test-a prospective multi-centre analytical and clinical evaluation

Citation

Cubas Atienzar, Ana Isabel et al. (2021), Accuracy of the mologic COVID-19 rapid antigen test-a prospective multi-centre analytical and clinical evaluation, Dryad, Dataset, https://doi.org/10.5061/dryad.0vt4b8gzq

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has highlighted the reliance on antigen detection rapid diagnostic tests (Ag-RDTs). Their evaluation at point of use is a priority. Here, we report a multi-centre evaluation of the analytical sensitivity, specificity, and clinical accuracy of the Mologic COVID-19 Ag-RDT by comparing to RT-qPCR results from individuals with and without COVID-19 symptoms. Participants attending secondary care facilities in Merseyside, ambulance services in Yorkshire, and drive-through testing facilities in Northumberland, UK.
The limit of detection of the Mologic COVID-19 Ag-RDT was 5.0 x 102 pfu/ml in swab matrix with no cross-reactivity and interference for any other pathogens tested. A total of 347 participants were enrolled from 26th of November 2020 to 15th of February 2021 with 39.2% (CI 34.0-44.6) testing RT-qPCR positive for SARS-CoV-2. The overall sensitivity and specificity of the Mologic Ag-RDT compared to the reference SARS-CoV-2 RT-qPCR were 85.0% (95% CI 78.3-90.2) and 97.8% (95.0-99.3), respectively. Sensitivity was stratified by RT-qPCR cycle threshold (Ct) and 98.4% (91.3-100) of samples with a Ct less than 20 and 93.2% (86.5-97.2) of samples with a Ct less than 25 were detected using the Ag-RDT. Clinical accuracy was stratified by sampling strategy, swab type and clinical presentation. Mologic COVID-19 Ag-RDT demonstrated highest sensitivity with nose/throat swabs compared with throat or nose swabs alone, however the differences were not statistically significant. Overall, the Mologic test had high diagnostic accuracy across multiple different settings, different demographics, and on self-collected swab specimens. These findings suggest the Mologic rapid antigen test may be deployed effectively across a range of use settings.

Funding

Wellcome Trust, Award: 220764

Wellcome Trust, Award: 204809

Pfizer, Award: WI2558862-2