The VALIDity of Laboratory Developed Tests: Leave it to the experts?

Mark A. Marzinke; William Clarke; Dennis J. Dietzen; Andrew N. Hoofnagle; Gwendolyn A. McMillin; Maria Alice V. Willrich

doi:10.1016/j.jmsacl.2022.12.002

The VALIDity of Laboratory Developed Tests: Leave it to the experts?

Mark A. Marzinke
, William Clarke
, Dennis J. Dietzen
, Andrew N. Hoofnagle
, Gwendolyn A. McMillin
, Maria Alice V. Willrich

Research output: Contribution to journal › Article › peer-review

Original language	English
Pages (from-to)	1-6
Number of pages	6
Journal	Journal of Mass Spectrometry and Advances in the Clinical Lab
Volume	27
DOIs	https://doi.org/10.1016/j.jmsacl.2022.12.002
State	Published - Jan 2023

Keywords

FDA
LDT
Laboratory developed test
Regulatory
Valid

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10.1016/j.jmsacl.2022.12.002

Cite this

@article{06d8cd5307554a6a910b533a9c93ba77,

title = "The VALIDity of Laboratory Developed Tests: Leave it to the experts?",

keywords = "FDA, LDT, Laboratory developed test, Regulatory, Valid",

author = "Marzinke, \{Mark A.\} and William Clarke and Dietzen, \{Dennis J.\} and Hoofnagle, \{Andrew N.\} and McMillin, \{Gwendolyn A.\} and Willrich, \{Maria Alice V.\}",

year = "2023",

month = jan,

doi = "10.1016/j.jmsacl.2022.12.002",

language = "English",

volume = "27",

pages = "1--6",

journal = "Journal of Mass Spectrometry and Advances in the Clinical Lab",

issn = "2667-145X",

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TY - JOUR

T1 - The VALIDity of Laboratory Developed Tests

T2 - Leave it to the experts?

AU - Marzinke, Mark A.

AU - Clarke, William

AU - Dietzen, Dennis J.

AU - Hoofnagle, Andrew N.

AU - McMillin, Gwendolyn A.

AU - Willrich, Maria Alice V.

PY - 2023/1

Y1 - 2023/1

KW - FDA

KW - LDT

KW - Laboratory developed test

KW - Regulatory

KW - Valid

UR - https://www.scopus.com/pages/publications/85143732891

U2 - 10.1016/j.jmsacl.2022.12.002

DO - 10.1016/j.jmsacl.2022.12.002

M3 - Article

C2 - 36532122

AN - SCOPUS:85143732891

SN - 2667-145X

VL - 27

SP - 1

EP - 6

JO - Journal of Mass Spectrometry and Advances in the Clinical Lab

JF - Journal of Mass Spectrometry and Advances in the Clinical Lab

ER -

The VALIDity of Laboratory Developed Tests: Leave it to the experts?

Keywords

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