Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The United Kingdom

Journal article

Objectives: 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.

Methods: 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.

Results: 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).

Conclusions: 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.

Authors: Palomino-Padilla, S; Finch, L; de Vos, M; Savage, H; Villa-Castillo, L

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: Public Library of Science
• Journal: PLoS ONE
• Volume: 18
• Issue: 3
• Article number: e0281925
• Publication date: 2023-03-03
• Acceptance date: 2023-02-03
• DOI: 10.1371/journal.pone.0281925
• EISSN: 1932-6203
• Pmid: 36867620
• Language: English
• Keywords: prospective studies; United Kingdom; LSTM diagnostics group; CONDOR steering group; SARS-CoV-2; Peru; COVID-19; UTB-IMTAvH group; FFR; COVID-19 testing