Multicenter Diagnostic Evaluation of OnSite COVID-19 Rapid Test (CTK Biotech) among Symptomatic Individuals in Brazil and the United Kingdom

• DOI: 10.1128/spectrum.05044-22
• Publication Date: 2023-05-22T14:04:56Z
• Authors: Caitlin R. Thompson; Pablo Muñoz Torres; Konstantina Konto...; Rachel L. Byrne; ; Saidy Vásconez No...; Alessandra Luna-M...; Ana Paula Marchi; Pâmela S. Andrade; Antonio dos Santo...; Marli Nishikawara; ; Richard Body; Margaretha de Vos; Camille Escadafal; Emily Adams; Silvia Figueiredo...; Ana I. Cubas-Atie...; ; Caitlin Greenland...; Kate Buist; Karina Clerkin; Thomas Edwards; Lorna Finch; Helen R. Savage; Jahanara Wardale; Rachel Watkins; Chris Williams; Dominic Wooding; ; A. Joy Allen; Julian Braybrook; Peter Buckle; Eloise Cook; Paul Dark; Kerrie Davis; Gail Hayward; Adam Gordon; Anna Halstead; Charlotte Harden; Colette Inkson; Naoko Jones; William Jones; Dan Lasserson; Joseph Lee; Clare Lendrem; Andrew Lewington; Mary Logan; Massimo Micocci; Brian Nicholson; Rafael Perera-Sal...; Graham Prestwich; D. Ashley Price; Charles Reynard; Beverley Riley; John Simpson; Valerie Tate; Philip Turner; Mark Wilcox; Melody Zhifang
• Keywords: Pandemic; 2019-20 coronavirus outbreak

The COVID-19 pandemic has given rise to numerous commercially available antigen rapid diagnostic tests (Ag-RDTs). To generate and share accurate independent data with the global community requires multisite prospective evaluations of Ag-RDTs. This report describes clinical evaluation OnSite test (CTK Biotech, CA, USA) in Brazil United Kingdom. A total 496 paired nasopharyngeal (NP) swabs were collected from symptomatic health care workers at Hospital das Clínicas São Paulo, Brazil, 211 NP participants a drive-through testing site Liverpool, Swabs analyzed by Ag-RDT, results compared quantitative reverse transcriptase PCR (RT-qPCR). sensitivity was 90.3% (95% confidence interval [CI], 75.1 96.7%) Kingdom 75.3% CI, 64.6 83.6%). specificity 99.4% 98.1 99.8%) 95.5% 90.6 97.9%). Concurrently, analytical Ag-RDT assessed using direct culture supernatant SARS-CoV-2 strains wild-type (WT), Alpha, Delta, Gamma, Omicron lineages. study provides comparative performance an across two different settings, geographical areas, populations. Overall, demonstrated lower than claimed manufacturer. fulfilled criteria determined World Health Organization, but obtained UK failed do. Further Ag-RDTs should include harmonized protocols between laboratories facilitate comparison settings. IMPORTANCE Evaluating diverse populations is essential improving responses as it gives indication accuracy real-world scenarios. In case within this pandemic, lateral flow that meet minimum requirements for can play key role increasing capacity, allowing timely management those infected, protecting systems. particularly valuable settings where access gold standard often restricted.