Establishment of reference range of HER2 by chemiluminescence method in healthy females.

Abstract

Objective: To establish reference range for serum HER2 levels in normal Asian females and provide a comprehensive overview of its current understanding to step towards improving the accuracy and utility of serum HER2 as biomarker. Study Design: Cross Sectional study. Setting: Farooq Hospital Westwood, College of Allied Health Sciences, Akhtar Saeed Medical & Dental College Lahore. Period: October 2024 to December 2024. Methods: The female participants visited aged 30-70 years, free of symptoms and signs suggestive of any breast abnormality were included. The 120 female participants were enrolled for establishing reference value of serum HER2 levels. The venous blood sample was drawn for HER2 levels. The auto analyzer was used for HER2 estimation. The data was analyzed through the IBM SPSS V.27.0. Results: A total 120 females were enrolled. The mean + SD was 45.0 + 9.879. The weighted average test was used to determine 25^th and 95^th percentile value in order to establish lower reference limit and upper reference limit of HER2 assay. The established reference range was 9.41 to 14.03 ng/ml. The results revealed that 25% data was below 9.41ng/ml and 95 % of females HER2 levels were under 14.03ng/ml. Conclusion: The present study established a preliminary reference range for serum HER2 in healthy females, contributing to improved breast cancer diagnostics and monitoring in our region.