The PrecivityAD™ test: Accurate and reliable LC-MS/MS assays for quantifying plasma amyloid beta 40 and 42 and apolipoprotein E proteotype for the assessment of brain amyloidosis

In accord with CLIA standards, we developed and validated assay performance: precision, accuracy, linearity, limit of detection, interferences

Kristopher M. Kirmess; Matthew R. Meyer; Mary S. Holubasch; Stephanie S. Knapik; Yan Hu; Erin N. Jackson; Scott E. Harpstrite; Philip B. Verghese; Tim West; Ilana Fogelman; Joel B. Braunstein; Kevin E. Yarasheski; John H. Contois

2021

Scholarcy highlights

  • There is an unmet need for an accessible, less invasive, cost-effective method to facilitate clinical trial enrollment and aid in clinical Alzheimer’s disease diagnosis
  • In accord with CLIA standards, we developed and validated assay performance: precision, accuracy, linearity, limit of detection, interferences
  • Within-day precision varied from 1.5–3.0% and 2.5–8.4%
  • The PrecivityAD™ assays are precise, accurate, sensitive, and linear over a wide analytical range, free from significant interferences, and suitable for use in the clinical laboratory

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