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

CubasAtienzar, Ana, Bell, Fiona, Byrne, Rachel, Buist, Kate, Clark, David J., Cocozza, Michael, Collins, Andrea ORCID:, Cuevas, Luis ORCID:, Duvoix, Annelyse, Easom, Nicholas, Edwards, Thomas, Ferreira, Daniela ORCID:, Fletcher, Tom, Groppelli, Elisabetta, Hyder-Wright, Angela, Kadamus, Ewelina, Kirwan, Daniela E., Kontogianni, Konstantina, Krishna, Sanjeev, Kluczna, Diana, Mark, Julian, Mensah-Kane, Josephine, Miller, Elisha, Mitsi, Elena, Norton, Donna, O'Connor, Emma, Owen, Sophie ORCID:, Planche, Tim, Shelley, Samuel, Staines, Henry M., Tate, David, Thompson, Caitlin, Walker, Gemma, Williams, Chris, Wooding, Dominic, Fitchett, Joseph R. A. and Adams, Emily ORCID: (2021) 'Accuracy of the Mologic COVID-19 rapid antigen test: a prospective multi-centre analytical and clinical evaluation'. Wellcome Open Research, Vol 6, p. 132.

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Background: 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.

Methods: 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 reverse transcriptase polymerase chain reaction (RT-qPCR) results from individuals with and without COVID-19 symptoms. Participants had attended hospitals in Merseyside, hospital and ambulance services in Yorkshire, and drive-through testing facilities in Northumberland, UK.

Results: 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.

Conclusions: 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.

Item Type: Article
Subjects: QY Clinical Pathology > QY 4 General works
WC Communicable Diseases > Virus Diseases > Viral Respiratory Tract Infections. Respirovirus Infections > WC 506 COVID-19
Faculty: Department: Biological Sciences > Department of Tropical Disease Biology
Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
Depositing User: Julie Franco
Date Deposited: 22 Feb 2022 15:08
Last Modified: 16 Jun 2023 12:20


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