1. The Future of Laboratory-Developed Tests in Hemostasis Laboratories.
- Author
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Gardiner C, Echenagucia M, and Gosselin RC
- Subjects
- Humans, Laboratories, Clinical Laboratory Services
- 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., Competing Interests: C.G. reports personal fees from Sysmex UK, outside the submitted work.R.C.G. reports personal fees from Sysmex America Inc, personal fees from Diagnostica Grifols, other from Diagnostica Stago, outside the submitted work., (Thieme. All rights reserved.) more...
- Published
- 2023
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