Developing a quality system for quantitative laboratory-Developed tests

Research output: Contribution to journalArticlepeer-review

4 Scopus citations


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 languageEnglish (US)
Pages (from-to)179-185
Number of pages7
JournalClinical Microbiology Newsletter
Issue number23
StatePublished - Dec 1 2011

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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