Shorts on Standards—Establishing cutoffs, reference ranges for biofluid biomarkers in Alzheimer’s disease: Reference materials and reference measurement procedures

Create PDF

Despite this success, there remains a need to develop reference measurement procedures and CRMs for other CSF and plasma biomarkers (e.g. NfL and p-tau). Availability of these reference procedures and CRMs will help to harmonize methods for establishing global cutoffs and reference ranges of additional biofluid biomarkers for screening, diagnosis, and prognosis of AD.

1. Jack CR Jr., Bennett DA, Blennow K, et al. NIA-AA research framework: toward a biological definition of Alzheimer’s disease. Alzheimers Dement. 2018;14(4):535–562.
2. Andreasson U, Kuhlmann J, Pannee J, et al. Commutability of the certified reference materials for the standardization of β-amyloid 1–42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1–40 measurements. Clin Chem Lab Med. 2018; doi:10.1515/cclm-2018-0147.

Dr. Li is an assistant professor in the Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, and Dr. Mielke is a professor in the Department of Health Sciences Research and Department of Neurology, Mayo Clinic College of Medicine, Rochester, Minn. Dr. Li is a member of the CAP Standards Committee.