The VALIDity of Laboratory Developed Tests: Leave it to the experts?
J Mass Spectrom Adv Clin Lab
.
2022 Dec 9:27:1-6.
doi: 10.1016/j.jmsacl.2022.12.002.
eCollection 2023 Jan.
Authors
Mark A Marzinke
1
2
,
William Clarke
1
,
Dennis J Dietzen
3
,
Andrew N Hoofnagle
4
5
,
Gwendolyn A McMillin
6
7
,
Maria Alice V Willrich
8
Affiliations
1
Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
2
Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
3
Departments of Pathology and Pediatrics, Washington University School of Medicine and St. Louis Children's Hospital, St. Louis, MO, USA.
4
Department of Laboratory Medicine and Pathology, University of Washington, Seattle, WA, USA.
5
Department of Medicine, University of Washington, Seattle, WA, USA.
6
ARUP Laboratories, Salt Lake City, UT, USA.
7
Department of Pathology, University of Utah Health, Salt Lake City, UT, USA.
8
Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
PMID:
36532122
PMCID:
PMC9755360
DOI:
10.1016/j.jmsacl.2022.12.002
No abstract available
Keywords:
FDA; LDT; Laboratory developed test; Regulatory; Valid.