Abstract Details

Title A Multi-Site Validation of Human A?42 and Human Total Tau Assays for Use in Human CSF

Topic Aging and Dementia

Presentation(s) IN3 - (-)

Poster/Presentation
Number 009

Objective

Background The MSD Human A?42 and Human Total Tau Kits have been validated internally for the detection of their respective analytes in human cerebrospinal fluid (CSF) using the "Fit for Purpose" criteria. Here we extend the validation of these kits to nine independent testing sites to assess their functional performance and the intra- and inter-center variability for each kit.

Design/Methods All testing sites were trained by an MSD field application scientist prior to conducting the validation experiments. Each site tested standard curves, quality controls, and 12 blinded CSF sample pools in four discrete runs per assay over two days. Matrix tolerance was evaluated by dilution linearity using 10 CSF sample pools diluted 2- to 32-fold in two discrete runs per assay over two days. All samples were evaluated against pre-defined acceptance criteria.

Results The Human A?42 and Human Total Tau Kits produced similar standard curves and analyte measurements for both concentration and signal across all testing sites. A?42 levels in diluent-based QC samples and CSF sample pools were more variable than total tau levels. Trends observed for the QC samples and CSF sample pools were consistent across sample IDs for a given site and analyte.

Conclusions A?42 and total tau levels measured in CSF sample pools correlate across all testing sites with coefficients of variation below 35 and 20 percent, respectively. We report that certain CSF sample pools exhibit large inter-center variability; ongoing studies are underway to determine the cause of sample-specific variability.

Authors/Disclosures
Pankaj Oberoi PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Tahseen Mozaffar, MD, FAAN (University of California Irvine)	Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Argenx. Dr. Mozaffar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Mozaffar has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amicus. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Grifols. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Astellas Gene Therapy. Dr. Mozaffar has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bayer. Dr. Mozaffar has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sarepta. Dr. Mozaffar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Applied Therapeutics. The institution of Dr. Mozaffar has received research support from NIH. The institution of Dr. Mozaffar has received research support from Muscular Dystrophy Association. The institution of Dr. Mozaffar has received research support from Sanofi. The institution of Dr. Mozaffar has received research support from Argenx. The institution of Dr. Mozaffar has received research support from Amicus Therapeutics. The institution of Dr. Mozaffar has received research support from Astellas Gene Therpay. The institution of Dr. Mozaffar has received research support from Cartesian. The institution of Dr. Mozaffar has received research support from Cabaletta. Dr. Mozaffar has received personal compensation in the range of $500-$4,999 for serving as a Study Section Member with NIH.

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