articleFrontiers in NeurologyAug 19, 2015GOLD OA

A Practical Guide to Immunoassay Method Validation

UAUlf AndréassonAPArmand Perret‐LiaudetLJLinda Josephine Christine van Waalwijk van DoornKBKaj BlennowDCDavide Chiasserini

University of Gothenburg · Inserm · +23 more institutions

PubMed
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Abstract

Biochemical markers have a central position in the diagnosis and management of patients in clinical medicine, and also in clinical research and drug development, also for brain disorders, such as Alzheimer's disease. The enzyme-linked immunosorbent assay (ELISA) is frequently used for measurement of low-abundance biomarkers. However, the quality of ELISA methods varies, which may introduce both systematic and random errors. This urges the need for more rigorous control of assay performance, regardless of its use in a research setting, in clinical routine, or drug development. The aim of a method validation is to present objective evidence that a method fulfills the requirements for its intended use. Although…

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Topics & keywords

Topics
Keywords
  • Computer science
  • Medical physics
  • Immunoassay
  • Drug development
  • Medicine
  • Data mining
  • Drug
  • Pharmacology
UN Sustainable Development Goals
  • Good health and well-being
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