A Practical Guide to Immunoassay Method Validation

Frontiers in Neurology
Ulf AndreassonCharlotte E Teunissen

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 much has been published on which parameters to investigate in a method validation, less is available on a detailed level on how to perform the corresponding experiments. To remedy this, standard operating procedures (SOPs) with step-by-step instructions for a number of different validation parameters is included in the present work together with a validation report template, which allow for a well-ordered presentation of the results. Even though the SOPs were developed with the intended use for immunochemical methods and to...Continue Reading

References

Oct 1, 1994·Journal of Clinical Microbiology·B D PlikaytisG M Carlone
Jan 7, 2006·Pharmaceutical Research·Jean W LeeJohn A Wagner
Feb 17, 2010·Nature Reviews. Neurology·Kaj BlennowHenrik Zetterberg
Dec 28, 2010·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Henning BlumeChristoph Siethoff
May 3, 2011·Journal of Pharmaceutical and Biomedical Analysis·Marie-Anne ValentinAlexandre Avrameas
May 27, 2011·Annales de biologie clinique·A VassaultUNKNOWN membres du sous-groupe 2 analytique de la SFBC
Dec 17, 2014·Nature Reviews. Neurology·Alberto LleóBrit Mollenhauer

❮ Previous
Next ❯

Citations

May 31, 2016·Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring·Charlotte E TeunissenYolande A L Pijnenburg
Jan 11, 2016·Journal of Neurochemistry·Linda J C van Waalwijk van DoornCharlotte E Teunissen
Apr 1, 2016·Journal of Huntington's Disease·Lauren M Byrne, Edward J Wild
Apr 23, 2016·Journal of Alzheimer's Disease : JAD·Eline A J WillemseCharlotte E Teunissen
Aug 29, 2016·Journal of Alzheimer's Disease : JAD·Virginia Pérez-GrijalbaManuel Sarasa
Mar 23, 2017·Journal of Assisted Reproduction and Genetics·Michael SchenkGregor Weiss
Aug 24, 2017·International Journal of Environmental Research and Public Health·Alberto Romão SinequeFilomena Rosa Dos Anjos
Nov 18, 2017·Journal of Veterinary Diagnostic Investigation : Official Publication of the American Association of Veterinary Laboratory Diagnosticians, Inc·Fernando TeclesJosé J Cerón
May 20, 2017·Annals of Surgery·Dirk H S M SchellekensJoep P M Derikx
Jul 25, 2018·Vaccines·Amy Flaxman, Katie J Ewer
Sep 10, 2018·Annals of Neurology·Inge M W VerberkWiesje M van der Flier
Jan 18, 2018·Proceedings of the National Academy of Sciences of the United States of America·Roxana JaliliHenrik H J Persson
Feb 23, 2018·Analytical Chemistry Insights·Michael G Weller
Jan 15, 2019·Journal of Veterinary Diagnostic Investigation : Official Publication of the American Association of Veterinary Laboratory Diagnosticians, Inc·Susan A McLeishKostas Papasouliotis
Sep 24, 2015·Nature Reviews. Neurology·Charlotte E TeunissenJoep Killestein
Nov 23, 2018·Molecular Neurobiology·Tainá M MarquesMarcel M Verbeek
Oct 9, 2018·Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring·Niels KruseFranc Llorens
Dec 11, 2019·The Journal of Biological Chemistry·Lakshmi Pillai-KastooriAmy R Schutz-Geschwender
Nov 19, 2019·Movement Disorders : Official Journal of the Movement Disorder Society·Linda P OosterveldWilma D J van de Berg
Jun 30, 2019·Clinical Chemistry and Laboratory Medicine : CCLM·Carlo WilkeMatthis Synofzik
Feb 23, 2020·Clinical and Experimental Medicine·Susanne FederChrista Buechler
May 21, 2020·The American Journal of Clinical Nutrition·Karen M O'Callaghan, Daniel E Roth
Nov 17, 2017·Journal of Immunoassay & Immunochemistry·Ahmed Sami Abu-Bakr El-BayoumyBsheer El-Sayed Bayoumy
Nov 5, 2016·Biological Chemistry·Kateryna KravchenkoDieter Willbold

❮ Previous
Next ❯

Methods Mentioned

BETA
enzyme-linked immunosorbent assay
ELISA

Software Mentioned

Excel
Umetrics
MODDE

Related Concepts

Related Feeds

CSF & Lymphatic System

This feed focuses on Cerebral Spinal Fluid (CSF) and the lymphatic system. Discover the latest papers using imaging techniques to track CSF outflow into the lymphatic system in animal models.