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

被引：6

作者：

Marzinke, Mark A. ^{[1
,2
,10
]}

Clarke, William ^{[1
]}

Dietzen, Dennis J. ^{[3
,4
]}

Hoofnagle, Andrew N. ^{[5
,6
]}

McMillin, Gwendolyn A. ^{[7
,8
]}

Willrich, Maria Alice, V ^{[9
]}

机构：

[1] Johns Hopkins Univ, Sch Med, Dept Pathol, Baltimore, MD 21287 USA

[2] Johns Hopkins Univ, Sch Med, Dept Med, Baltimore, MD 21287 USA

[3] Washington Univ, Sch Med, Dept Pathol & Pediat, St Louis, MO USA

[4] St Louis Childrens Hosp, St Louis, MO USA

[5] Univ Washington, Dept Lab Med & Pathol, Seattle, WA USA

[6] Univ Washington, Dept Med, Seattle, WA USA

[7] ARUP Labs, Salt Lake City, UT USA

[8] Univ Utah Hlth, Dept Pathol, Salt Lake City, UT USA

[9] Mayo Clin, Dept Lab Med & Pathol, Rochester, MN USA

[10] Johns Hopkins Univ, Sch Med, Div Clin Pharmacol, 1800 Orleans St, Sheikh Zayed Tower, Room B1-1020F, Baltimore, MD 21287 USA

来源：

JOURNAL OF MASS SPECTROMETRY AND ADVANCES IN THE CLINICAL LAB | 2023年 / 27卷

关键词：

LDT; Regulatory; Laboratory developed test; Valid; FDA;

D O I：

10.1016/j.jmsacl.2022.12.002

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

[No abstract available]

引用

页码：1 / 6

页数：6