Laboratory developed tests in the clinical laboratory: challenges for implementation-Reference-Cited by-同舟云学术

Laboratory developed tests in the clinical laboratory: challenges for implementation

Published:2015-08 Issue:15 Volume:7 Page:1817-1820
ISSN:1757-6180
Container-title:Bioanalysis
language:en
Short-container-title:Bioanalysis

Author:

Marzinke Mark A¹²,Clarke William¹

Affiliation:

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

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Link

http://www.future-science.com/doi/pdf/10.4155/bio.15.109

Reference12 articles.

1. American Society of Clinical Pathology Policy Statement: Regulation of Laboratory Developed Tests (LDTs); Policy Number 10–02 (2010). www.ascp.org/PDF/Advocacy/Regulation-of-laboratory-developed-tests-LDTs.aspx.

2. The Long and Winding Regulatory Road for Laboratory-Developed Tests

3. LDTs and CLIA FAQs. v. 2013.10.22 (2013). www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/LDT-and-CLIA_FAQs.pdf.

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