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Andreasson U, Perret-Liaudet A, van Waalwijk van Doorn LJ, et al. A Practical Guide to Immunoassay Method Validation. Front Neurol. 2015;6:179doi: 10.3389/fneur.2015.00179.
Andreasson, U., Perret-Liaudet, A., van Waalwijk van Doorn, L. J., Blennow, K., Chiasserini, D., Engelborghs, S., Fladby, T., Genc, S., Kruse, N., Kuiperij, H. B., Kulic, L., Lewczuk, P., Mollenhauer, B., Mroczko, B., Parnetti, L., Vanmechelen, E., Verbeek, M. M., Winblad, B., Zetterberg, H., Koel-Simmelink, M., & Teunissen, C. E. (2015). A Practical Guide to Immunoassay Method Validation. Frontiers in neurology, 6179. https://doi.org/10.3389/fneur.2015.00179
Andreasson, Ulf, et al. "A Practical Guide to Immunoassay Method Validation." Frontiers in neurology vol. 6 (2015): 179. doi: https://doi.org/10.3389/fneur.2015.00179
Andreasson U, Perret-Liaudet A, van Waalwijk van Doorn LJ, Blennow K, Chiasserini D, Engelborghs S, Fladby T, Genc S, Kruse N, Kuiperij HB, Kulic L, Lewczuk P, Mollenhauer B, Mroczko B, Parnetti L, Vanmechelen E, Verbeek MM, Winblad B, Zetterberg H, Koel-Simmelink M, Teunissen CE. A Practical Guide to Immunoassay Method Validation. Front Neurol. 2015 Aug 19;6:179. doi: 10.3389/fneur.2015.00179. eCollection 2015. PMID: 26347708; PMCID: PMC4541289.
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Front Neurol. 2015 Aug 19;6:179. doi: 10.3389/fneur.2015.00179. eCollection 2015.

A Practical Guide to Immunoassay Method Validation.

Frontiers in neurology

Ulf Andreasson, Armand Perret-Liaudet, Linda J C van Waalwijk van Doorn, Kaj Blennow, Davide Chiasserini, Sebastiaan Engelborghs, Tormod Fladby, Sermin Genc, Niels Kruse, H Bea Kuiperij, Luka Kulic, Piotr Lewczuk, Brit Mollenhauer, Barbara Mroczko, Lucilla Parnetti, Eugeen Vanmechelen, Marcel M Verbeek, Bengt Winblad, Henrik Zetterberg, Marleen Koel-Simmelink, Charlotte E Teunissen

Affiliations

  1. Clinical Neurochemistry Laboratory, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg , Mölndal , Sweden.
  2. Neurobiology Laboratory, Centre for Memory Resources and Research (CMRR), Groupement Hospitalier Est (GHE), Hôpitaux de Lyon, Université Lyon 1, CNRS UMR5292, INSERM U1028 , Lyon , France.
  3. Department of Neurology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center , Nijmegen , Netherlands ; Department of Laboratory Medicine, Donders Institute for Brain, Cognition and Behaviour, Radboud Alzheimer Centre , Nijmegen , Netherlands.
  4. Laboratory of Clinical Neurochemistry, Department of Medicine, Section of Neurology, University of Perugia , Perugia , Italy.
  5. Reference Center for Biological Markers of Dementia (BIODEM), Institute Born-Bunge, University of Antwerp , Antwerp , Belgium ; Department of Neurology and Memory Clinic, Hospital Network Antwerp (ZNA) Middelheim and Hoge Beuken , Antwerp , Belgium.
  6. University of Oslo , Oslo , Norway ; Department of Neurology, Akershus University Hospital , Lørenskog , Norway.
  7. Department of Neuroscience, Institute of Health Science, Dokuz Eylul University , Izmir , Turkey.
  8. Department of Neuropathology, University Medical Center , Göttingen , Germany.
  9. Division of Psychiatry Research, University of Zurich , Schlieren , Switzerland.
  10. Department of Psychiatry and Psychotherapy, Universitätsklinikum Erlangen, Friedrich-Alexander Universität Erlangen-Nürnberg , Erlangen , Germany.
  11. Paracelsus-Elena Klinik , Kassel , Germany ; Department of Neuropathology, University Medical Center Göttingen , Göttingen , Germany.
  12. Department of Neurodegeneration Diagnostics, Medical University of Bia?ystok , Bia?ystok , Poland.
  13. ADx NeuroSciences , Ghent , Belgium.
  14. Karolinska Institutet , Stockholm , Sweden.
  15. Clinical Neurochemistry Laboratory, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg , Mölndal , Sweden ; Institute of Neurology, University College London , London , UK.
  16. Neurochemistry Laboratory and Biobank, Department of Clinical Chemistry, Neurocampus Amsterdam, VU University Medical Center , Amsterdam , Netherlands.

PMID: 26347708 PMCID: PMC4541289 DOI: 10.3389/fneur.2015.00179

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.

Keywords: immunoassays; limits of quantitation; method validation; precision; robustness

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