Developing a quality system for quantitative laboratory-Developed tests

Thomas E. Grys

doi:10.1016/j.clinmicnews.2011.11.001

Developing a quality system for quantitative laboratory-Developed tests

Thomas E. Grys

Laboratory Medicine and Pathology

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

4 Scopus citations

Abstract

Users of laboratory-developed assays face many challenges. In addition to designing an assay, collecting specimens for validation, and completing the validation, they must also design and implement a quality system to ensure continued performance of the assay. The situation is even more complex when dealing with a quantitative assay. This article presents some considerations for navigating the world of quantitative laboratory-developed assays and proposes a paradigm for developing a quality system for these assays.

Original language	English (US)
Pages (from-to)	179-185
Number of pages	7
Journal	Clinical Microbiology Newsletter
Volume	33
Issue number	23
DOIs	https://doi.org/10.1016/j.clinmicnews.2011.11.001
State	Published - Dec 1 2011

ASJC Scopus subject areas

Microbiology (medical)
Infectious Diseases

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10.1016/j.clinmicnews.2011.11.001

Cite this

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Developing a quality system for quantitative laboratory-Developed tests

Abstract

ASJC Scopus subject areas

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