Laboratory developed tests in the clinical laboratory: challenges for implementation

Bioanalysis. 2015;7(15):1817-20. doi: 10.4155/bio.15.109.

Authors

Mark A Marzinke^{1

2}, William Clarke¹

Affiliations

¹ Department of Medicine, Johns Hopkins University School of Medicine, 1800 Orleans St. Sheikh Zayed Tower, B1020-F, Baltimore, MD 21287, USA.
² Department of Pathology, Johns Hopkins University School of Medicine Baltimore, MD 21287, USA.

PMID: 26295983
DOI: 10.4155/bio.15.109

No abstract available

Keywords: Clinical Laboratory Improvement Amendments; US FDA; laboratory developed tests; oversight; regulation.

Publication types

Editorial

MeSH terms

Clinical Laboratory Services / statistics & numerical data*
Clinical Laboratory Techniques / methods*
Humans