Competitive ELISA studies of neural thread protein in urine in Alzheimer's disease.

A specific and reliable competitive affinity assay kit has been developed to quantitatively measure neural thread protein (NTP) in first morning urine samples. This assay, called the urine neural thread protein test (UNTP), is a competitive enzyme-linked immunosorbent assay (ELISA) format affinity assay using 32-well microtiter plates. The assay detects UNTP in the 10-60 microg/mL range (an improvement over earlier assays of 10(3) x ), is linear and more reproducible (average coefficient of variation [CV] 6.

A multi-center blinded prospective study of urine neural thread protein measurements in patients with suspected Alzheimer's disease.

Objective: To investigate the utility of a clinical laboratory ELISA format assay that measures neural thread protein (NTP) in urine in the assessment of patients presenting with cognitive symptoms.

Design: A prospective blinded multicentered study.

Setting: Eight US specialty clinics for the evaluation of cognitive or memory disorder or dementia, including memory disorder and dementia clinics, neurology clinics, and psychiatry clinics, in 8 states.