A Practical Guide to Immunoassay Method Validation
Andreasson U, Perret-Liaudet A, Van Doorn LJCVW, Blennow K, Chiasserini D, Engelborghs S, Fladby T, Genc S, Kruse N, Kuipenj HB, Kulic L, Lewczuk P, Mollenhauer B, Mroczko B, Pametti L, Vanmechelen E, Verbeek MM, Winblad B, Zetterberg H, Koel-Simmelink M, Teunissen CE (2015)
Publication Type: Journal article
Publication year: 2015
Journal
Book Volume: 6
Pages Range: 179
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 be used for multicenter evaluations, most of them are generic and can be used for other technologies as well.
Authors with CRIS profile
Involved external institutions
University of Zurich / Universität Zürich (UZH)
Switzerland (CH)
Vrije Universiteit Amsterdam (VU) / University Amsterdam
Netherlands (NL)
University of Gothenburg / Göteborgs universitet
Sweden (SE)
Karolinska Institute
Sweden (SE)
Radboud University Nijmegen
Netherlands (NL)
ADx NeuroSciences
Belgium (BE)
Università degli Studi di Perugia
Italy (IT)
University of Białystok
Poland (PL)
Paracelsus-Elena-Klinik Kassel
Germany (DE)
Universitätsklinikum Heidelberg
Germany (DE)
Dokuz Eylül Üniversitesi (DEU)
Turkey (TR)
University of Oslo
Norway (NO)
University of Antwerp / Universiteit Antwerpen
Belgium (BE)
Université Claude Bernard Lyon 1 (UCB)
France (FR)
Switzerland (CH)
Vrije Universiteit Amsterdam (VU) / University Amsterdam
Netherlands (NL)
University of Gothenburg / Göteborgs universitet
Sweden (SE)
Karolinska Institute
Sweden (SE)
Radboud University Nijmegen
Netherlands (NL)
ADx NeuroSciences
Belgium (BE)
Università degli Studi di Perugia
Italy (IT)
University of Białystok
Poland (PL)
Paracelsus-Elena-Klinik Kassel
Germany (DE)
Universitätsklinikum Heidelberg
Germany (DE)
Dokuz Eylül Üniversitesi (DEU)
Turkey (TR)
University of Oslo
Norway (NO)
University of Antwerp / Universiteit Antwerpen
Belgium (BE)
Université Claude Bernard Lyon 1 (UCB)
France (FR)
How to cite
APA:
Andreasson, U., Perret-Liaudet, A., Van Doorn, L.J.C.V.W., Blennow, K., Chiasserini, D., Engelborghs, S.,... Teunissen, C.E. (2015). A Practical Guide to Immunoassay Method Validation. Frontiers in Neurology, 6, 179. https://doi.org/10.3389/fneur.2015.00179
MLA:
Andreasson, Ulf, et al. "A Practical Guide to Immunoassay Method Validation." Frontiers in Neurology 6 (2015): 179.
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