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Diagnostic performance of GENEDIA W and ActiveXpress+ COVID-19 antigens tests among symptomatic individuals in Peru and The United Kingdom.
Palomino-Padilla, Sandra; Finch, Lorna; de Vos, Margaretha; Savage, Helen; Villa-Castillo, Luz; Hayward, Gail; Cook, Eloïse; Escadafal, Camille; Body, Richard; Adams, Emily R; Ugarte-Gil, Cesar; Cubas-Atienzar, Ana I.
Afiliación
  • Palomino-Padilla S; Liverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United Kingdom.
  • Finch L; Unidad de Investigación de Tuberculosis del Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
  • de Vos M; FIND, Geneva, Switzerland.
  • Savage H; Unidad de Investigación de Tuberculosis del Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
  • Villa-Castillo L; Liverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United Kingdom.
  • Hayward G; Oxford University, Oxford, United Kingdom.
  • Cook E; Manchester University NHS Foundation Trust, Manchester, United Kingdom.
  • Escadafal C; FIND, Geneva, Switzerland.
  • Body R; Manchester University NHS Foundation Trust, Manchester, United Kingdom.
  • Adams ER; Unidad de Investigación de Tuberculosis del Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
  • Ugarte-Gil C; Liverpool School of Tropical Medicine, Centre for Drugs and Diagnostics, Liverpool, United Kingdom.
  • Cubas-Atienzar AI; Unidad de Investigación de Tuberculosis del Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
PLoS One ; 18(3): e0281925, 2023.
Article en En | MEDLINE | ID: mdl-36867620
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.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies / Observational_studies Límite: Humans País/Región como asunto: America do sul / Europa / Peru Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: SARS-CoV-2 / COVID-19 Tipo de estudio: Diagnostic_studies / Observational_studies Límite: Humans País/Región como asunto: America do sul / Europa / Peru Idioma: En Revista: PLoS One Asunto de la revista: CIENCIA / MEDICINA Año: 2023 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Estados Unidos