Multicenter diagnostic evaluation of onsite COVID-19 Rapid Test (CTK Biotech) among symptomatic individuals in Brazil and the United Kingdom

Thompson, CR; Torres, PM; Kontogianni, K; Byrne, RL; LSTM Diagnostic group; Noguera, SV; Luna-Muschi, A; Marchi, AP; Andrade, PS; Dos Santos Barboza, A; Nishikawara, M; CONDOR steering group; Body, R; de Vos, M; Escadafal, C; Adams, E; Figueiredo Costa, S; Cubas-Atienzar, AI

Journal article

Multicenter diagnostic evaluation of onsite COVID-19 Rapid Test (CTK Biotech) among symptomatic individuals in Brazil and the United Kingdom

Abstract:: The COVID-19 pandemic has given rise to numerous commercially available antigen rapid diagnostic tests (Ag-RDTs). To generate and to share accurate and independent data with the global community requires multisite prospective diagnostic evaluations of Ag-RDTs. This report describes the clinical evaluation of the OnSite COVID-19 rapid test (CTK Biotech, CA, USA) in Brazil and the United Kingdom. A total of 496 paired nasopharyngeal (NP) swabs were collected from symptomatic health care workers at Hospital das Clínicas in São Paulo, Brazil, and 211 NP swabs were collected from symptomatic participants at a COVID-19 drive-through testing site in Liverpool, United Kingdom. Swabs were analyzed by Ag-RDT, and results were compared to quantitative reverse transcriptase PCR (RT-qPCR). The clinical sensitivity of the OnSite COVID-19 rapid test in Brazil was 90.3% (95% confidence interval [CI], 75.1 to 96.7%) and in the United Kingdom was 75.3% (95% CI, 64.6 to 83.6%). The clinical specificity in Brazil was 99.4% (95% CI, 98.1 to 99.8%) and in the United Kingdom was 95.5% (95% CI, 90.6 to 97.9%). Concurrently, analytical evaluation of the Ag-RDT was assessed using direct culture supernatant of SARS-CoV-2 strains from wild-type (WT), Alpha, Delta, Gamma, and Omicron lineages. This study provides comparative performance of an Ag-RDT across two different settings, geographical areas, and populations. Overall, the OnSite Ag-RDT demonstrated a lower clinical sensitivity than claimed by the manufacturer. The sensitivity and specificity from the Brazil study fulfilled the performance criteria determined by the World Health Organization, but the performance obtained from the UK study failed to do. Further evaluation of Ag-RDTs should include harmonized protocols between laboratories to facilitate comparison between settings

Publication status:: Published

Peer review status:: Peer reviewed

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APA Style

Thompson, C. R., Torres, P. M., Kontogianni, K., Byrne, R. L., group, L. S. T. M. D., Noguera, S. V., Luna-Muschi, A., Marchi, A. P., Andrade, P. S., Dos Santos Barboza, A., Nishikawara, M., steering group, C. O. N. D. O. R., Body, R., de Vos, M., Escadafal, C., Adams, E., Figueiredo Costa, S., & Cubas-Atienzar, A. I. (2023). Multicenter diagnostic evaluation of onsite COVID-19 Rapid Test (CTK Biotech) among symptomatic individuals in Brazil and the United Kingdom. Microbiology Spectrum, 11(3).

MLA Style

Thompson, C. R., et al. “Multicenter Diagnostic Evaluation of Onsite COVID-19 Rapid Test (CTK Biotech) among Symptomatic Individuals in Brazil and the United Kingdom.” Microbiology Spectrum, vol. 11, no. 3, American Society for Microbiology, 2023.

Chicago Style

Thompson, CR, PM Torres, K Kontogianni, RL Byrne, LSTM Diagnostic group, SV Noguera, A Luna-Muschi, et al. 2023. “Multicenter Diagnostic Evaluation of Onsite COVID-19 Rapid Test (CTK Biotech) among Symptomatic Individuals in Brazil and the United Kingdom.” Microbiology Spectrum 11 (3).
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