The Future of Laboratory-Developed Tests in Hemostasis Laboratories.
Semin Thromb Hemost
; 49(6): 634-640, 2023 Sep.
Article
em En
| MEDLINE
| ID: mdl-36603812
ABSTRACT
Laboratory-developed tests (LDTs) are widely used in clinical hemostasis laboratories. The extent to which LDTs are regulated varies greatly around the world, and proposed changes to regulations have raised concerns about the future of LDTs in clinical laboratories. It is increasingly difficult to justify the use of an LDT where a commercially available method with regulatory approval is available. Conversely, where there is no suitable test with regulatory approval and there is a compelling clinical need, using an LDT outweighs the risk associated with not performing the test. We argue that LDTs are still required in specialist clinical laboratories to fulfill unmet clinical needs, and in lower middle-income countries where they are a vital resource.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Serviços de Laboratório Clínico
/
Laboratórios
Limite:
Humans
Idioma:
En
Revista:
Semin Thromb Hemost
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Reino Unido