Evaluation of rapid antigen detection kit from the WHO Emergency Use List for detecting SARS-CoV-2

BACKGROUND: Currently, there are two rapid antigen detection (RAD) kits from the WHO Emergency Use List for detecting SARS-CoV-2. OBJECTIVE: The Panbio COVID-19 Ag Rapid Test Device was selected to evaluate the performance for detecting SARS-CoV-2. STUDY DESIGN: Analytical sensitivity for the detect...

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Detalles Bibliográficos
Autores principales: Mak, Gannon C.K., Lau, Stephen S.Y., Wong, Kitty K.Y., Chow, Nancy L.S., Lau, C.S., Lam, Edman T.K., Chan, Rickjason C.W., Tsang, Dominic N.C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier B.V. 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716730/
https://www.ncbi.nlm.nih.gov/pubmed/33338894
http://dx.doi.org/10.1016/j.jcv.2020.104712
Descripción
Sumario:BACKGROUND: Currently, there are two rapid antigen detection (RAD) kits from the WHO Emergency Use List for detecting SARS-CoV-2. OBJECTIVE: The Panbio COVID-19 Ag Rapid Test Device was selected to evaluate the performance for detecting SARS-CoV-2. STUDY DESIGN: Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients. RESULTS: The LOD results showed that the RAD kit was 100 fold less sensitive than RT-PCR. Clinical sensitivity of the RAD kit was 68.6 % for detecting specimens from COVID-19 patients. CONCLUSIONS: The RAD kit evaluated in the present study shared similar performance with another kit from the WHO Emergency Use List, the Standard Q COVID-19 Ag. Understanding the clinical characteristics of RAD kits can guide us to decide different testing strategies in different settings.

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