Current regulatory landscape for viral point-of-care testing in the United States.
J Clin Virol
; 164: 105492, 2023 07.
Article
em En
| MEDLINE
| ID: mdl-37210882
ABSTRACT
Historically, the diagnosis of viral infections has been accomplished using a combination of laboratory-based methods, including culture, serology, antigen-based tests, and molecular (e.g., real-time PCR) assays. Although these methods provide an accurate way to detect viral pathogens, testing in a centralized laboratory may delay results, which could impact patient diagnosis and management. Point-of-care tests, including antigen- and molecular-based assays, have been developed to assist with the timely diagnosis of several viral infections, such as influenza, respiratory syncytial virus, and COVID-19. Despite the ability of point-of-care tests to provide rapid results (i.e., <30 min), there are issues to consider prior to their routine use, including test performance and specific regulatory requirements. This review will provide a summary of the regulatory landscape of point-of-care tests for viral infections in the United States, and address important considerations such as site certification, training and inspection readiness.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Viroses
/
Vírus Sincicial Respiratório Humano
/
COVID-19
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article