Validation of soluble amyloid-β precursor protein assays as diagnostic CSF biomarkers for neurodegenerative diseases
Linda J.C. van Waalwijk van Doorn, Marleen J. Koel-Simmelink, Ute Haußmann, Hans Klafki, Hanne Struyfs, Philipp Linning, Hans-Joachim Knölker, Harry Twaalfhoven, H. Bea Kuiperij, Sebastiaan Engelborghs, Philip Scheltens, Marcel M. Verbeek, Eugeen Vanmechelen, Jens Wiltfang and Charlotte E. Teunissen
Article first published online: 24 JAN 2016 | DOI: 10.1111/jnc.13527
We analytically validated the performance of assays detecting soluble amyloid-β precursor protein (sAPP) α and β in CSF according to SOPs in agreement with ISO15189 guidelines. The validated sAPP assays appear to be of sufficient technical quality and perform well. Moreover, this study proofs that the newly developed SOPs, with a minor modification, provide highly useful tools for the validation of new biomarker assays.