Article ; Online: Current regulatory landscape for viral point-of-care testing in the United States.
2023 Volume 164, Page(s) 105492
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 ... ...
| 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. |
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| MeSH term(s) | Humans ; United States ; COVID-19/diagnosis ; Molecular Diagnostic Techniques/methods ; Point-of-Care Testing ; Virus Diseases/diagnosis ; Respiratory Syncytial Virus, Human/genetics ; Sensitivity and Specificity ; Point-of-Care Systems |
| Language | English |
| Publishing date | 2023-05-17 |
| Publishing country | Netherlands |
| Document type | Journal Article ; Review |
| ZDB-ID | 1446080-4 |
| ISSN | 1873-5967 ; 1386-6532 |
| ISSN (online) | 1873-5967 |
| ISSN | 1386-6532 |
| DOI | 10.1016/j.jcv.2023.105492 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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