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2015 ; 6
(ä): 179
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A Practical Guide to Immunoassay Method Validation
#MMPMID26347708
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
Front Neurol
2015[]; 6
(ä): 179
PMID26347708
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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.
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