Palomino-Padilla, Sandra, Finch, Lorna 
ORCID: 0000-0002-8167-8766, de Vos, Margaretha, Savage, Helen, Villa-Castillo, Luz, Hayward, Gail, Cook, Eloise R, Escadafal, Camille, Body, Richard I, Adams, Emily P et al (show 2 more authors)
(2023)
Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The United Kingdom.
PLOS ONE, 18 (3).
e0281925-.
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Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The .pdf - Open Access published version Download (481kB) | Preview |
Abstract
<h4>Objectives</h4>In order to generate independent performance data regarding accuracy of COVID-19 antigen-based rapid diagnostic tests (Ag-RDTs), prospective diagnostic evaluation studies across multiple sites are required to evaluate their performance in different clinical settings. This report describes the clinical evaluation the GENEDIA W COVID-19 Ag Device (Green Cross Medical Science Corp., Chungbuk, Korea) and the ActiveXpress+ COVID-19 Complete Testing Kit (Edinburgh Genetics Ltd, UK), in two testing sites Peru and the United Kingdom.<h4>Methods</h4>Nasopharyngeal swabs collected from 456 symptomatic patients at primary points of care in Lima, Peru and 610 symptomatic participants at a COVID-19 Drive-Through testing site in Liverpool, England were analyzed by Ag-RDT and compared to RT-PCR. Analytical evaluation of both Ag-RDTs was assessed using serial dilutions of direct culture supernatant of a clinical SARS-CoV-2 isolate from the B.1.1.7 lineage.<h4>Results</h4>For GENEDIA brand, the values of overall sensitivity and specificity were 60.4% [95% CI 52.4-67.9%], and 99.2% [95% CI 97.6-99.7%] respectively; and for Active Xpress+ the overall values of sensitivity and specificity were 66.2% [95% CI 54.0-76.5%], and 99.6% [95% CI 97.9-99.9%] respectively. The analytical limit of detection was determined at 5.0 x 102 pfu/ml what equals to approximately 1.0 x 104 gcn/ml for both Ag-RDTs. The UK cohort had lower median Ct values compared to that of Peru during both evaluations. When split by Ct, both Ag-RDTs had optimum sensitivities at Ct<20 (in Peru; 95% [95% CI 76.4-99.1%] and 100.0% [95% CI 74.1-100.0%] and in the UK; 59.2% [95% CI 44.2-73.0%] and 100.0% [95% CI 15.8-100.0%], for the GENDIA and the ActiveXpress+, respectively).<h4>Conclusions</h4>Whilst the overall clinical sensitivity of the Genedia did not meet WHO minimum performance requirements for rapid immunoassays in either cohort, the ActiveXpress+ did so for the small UK cohort. This study illustrates comparative performance of Ag-RDTs across two global settings and considers the different approaches in evaluation methods.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | LSTM diagnostics group, UTB-IMTAvH group, CONDOR steering group, Humans, Prospective Studies, Peru, United Kingdom, COVID-19, SARS-CoV-2, COVID-19 Testing |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 19 Apr 2023 16:39 |
| Last Modified: | 13 Jul 2023 10:13 |
| DOI: | 10.1371/journal.pone.0281925 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3169776 |
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