A SANDWICH ENZYME-IMMUNOASSAY FOR MEASURING AD7C-NTP AS AN ALZHEIMERS-DISEASE MARKER - AD7C TEST

A simple, fast, reliable, and specific immunoassay has been developed to detect and measure AD7C-NTP, a biochemical marker for Alzheimer's d isease, in cerebrospinal fluid (CSF). This assay, called the AD7C Test , is an enzyme-linked sandwich immunoassay (ELSIA) using 96 well micro titer plates. The plate surface is coated with a monoclonal antibody ( N3I4) which has a high affinity and specificity for AD7C-NTP, capturin g it effectively from CSF samples. The detection was achieved using a polyclonal antibody (ADRI). Both N3I4 and ADRI were generated using re combinantly produced AD7C-NTP. The assay is highly sensitive (30-50 pg ), linear to 2.0 ng (r(2) > 0.99), and reproducible (C.V. < 10%). The utility of the assay has been demonstrated using CSF specimens from ea rly Alzheimer's disease patients and age matched controls (sensitivity of 89% and specificity of 89%). (C) 1998 Wiley-Liss, Inc.