Performance Evaluation of a Newly Developed Chemiluminescent Assay Kit for Detection of Neuron-Specific Eno.

Background: To evaluate the performance of a chemiluminescence detection reagent for Neuron-specific enolase (NSE).

Methods: Based on the "Guiding principles on performance analysis of diagnostic, reagents in vitro" and the Clinical and Laboratory Standards Institute (CLSI) Guidelines, performance of the CLIA NSE kit was evaluated, including the detection limit, linear range, reportable range, accuracy, precision, cross reactivity, interference factors, Hook effect, and method comparison.

Results: The detection limit of the reagent was 0.