Development and performance evaluations of an HER-2 kit.

Objective To develop a kit for detecting human epidermal growth factor receptor 2 (HER-2) in the human body. Methods The HER-2 kit was evaluated based on an automated magnetic particle chemiluminescence platform. The kit was developed using the double antibody sandwich-complexation method. Results The kit showed a linear range of 0.01–800 ng/mL, with a linear R2 of >0.999. The limit of the blank was 0.0039 ng/mL, and the precision at 1.00 ng/mL was 9.4%. The recovery rate at 10.00 ng/mL was 97.81–101.81%. The negative serum reference range was 0–8.23 ng/mL. Conclusions The kit had a wide linear range, high accuracy, good precision, and high sensitivity, indicating that it has good application prospects. Based on this principle, different optimization conditions were used to improve the performance of the HER-2 kit. [Display omitted] • Optimize preparation method. • Optimize reaction conditions. • Perform performance evaluation of the HER-2 kit. [ABSTRACT FROM AUTHOR]