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Development of an approach to monitor the manufacturing consistency of HIV rapid diagnostic tests: Panel qualification and potential impact on country programs

Although regulatory bodies have standards that manufacturers of rapid diagnostic tests (RDTs) must meet for market approval, RDTs have no specific sampling and testing standards to monitor ongoing lot production, unlike pharmaceuticals and certain devices. With the importance of accurate diagnosis f...

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Detalles Bibliográficos
Autores principales: Jenkins, David, Peck, Roger, Fernando, Ashini
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10085047/
https://www.ncbi.nlm.nih.gov/pubmed/37036848
http://dx.doi.org/10.1371/journal.pone.0284175