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Related Experiment Video

Updated: Aug 2, 2025

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
08:28

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells

Published on: May 9, 2025

209

Development and performance evaluations of an HER-2 kit.

Ying Cui1, Cai-Xia Wang1, Wen-Juan Yang1

  • 1Faculty of Medical Device, School of Shenyang Pharmaceutical University, Shenyang, 110016, China.

Analytical Biochemistry
|April 18, 2023
PubMed
Summary

A new kit for detecting human epidermal growth factor receptor 2 (HER-2) shows excellent performance. This diagnostic tool offers a wide linear range, high accuracy, and sensitivity for HER-2 detection.

Keywords:
Human epidermal growth factor receptor 2Kit evaluationMagnetic particle immunoassay

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Area of Science:

  • Biochemistry
  • Immunology
  • Clinical Diagnostics

Background:

  • Human epidermal growth factor receptor 2 (HER-2) is a key biomarker in certain cancers.
  • Accurate and sensitive detection of HER-2 is crucial for diagnosis and treatment monitoring.

Purpose of the Study:

  • To develop and evaluate a novel kit for the quantitative detection of HER-2.
  • To assess the performance characteristics of the developed HER-2 detection kit.

Main Methods:

  • Development of a HER-2 detection kit utilizing the double antibody sandwich-complexation method.
  • Evaluation of the kit on an automated magnetic particle chemiluminescence platform.

Main Results:

  • The HER-2 kit demonstrated a wide linear range (0.01-800 ng/mL) with R² > 0.999.
  • High sensitivity was observed with a limit of blank at 0.0039 ng/mL.
  • Excellent precision (9.4% at 1.00 ng/mL) and recovery rates (97.81-101.81% at 10.00 ng/mL) were achieved.

Conclusions:

  • The developed HER-2 detection kit exhibits a broad linear range, high accuracy, and good precision.
  • The kit's high sensitivity and robust performance indicate significant potential for clinical applications in HER-2 diagnostics.