Abstract
In this study, a novel dual-label time-resolved fluoroimmunoassay (TRFIA) is described for simultaneous quantification of human epidermal growth factor receptor 2 (HER-2) and human epididymis protein 4 (HE4) in serum to screen gynecologic cancers. A double-antibody sandwich TRFIA was introduced with europium and samarium chelates to simultaneously detect the concentrations of HER-2 and HE4. Under optimal conditions, the proposed method exhibited wide linear ranges for HER-2 of 0.07–500 ng ml−1 and for HE4 of 0.32–1000 pmol l−1 with the average coefficient of variation below 10%. The specificity was satisfied through determining the other common tumor markers. The recovery rates were 94.5% and 96.6% on average for HER-2 and HE4, respectively. Good correlations were observed in clinical samples between developed method and commercial chemiluminescence immunoassay kits. The results demonstrated that dual-label TRFIA for HER-2 and HE4 was rapid and precise, and therefore could have a promising use in large sample detection for gynecological cancer screening.
Highlights
Women’s health is related to themselves and to their families
Since human epidermal growth factor receptor 2 (HER-2, named ERBB2) and human epididymis secretory protein 4 (HE4, known as WAP four-disulfide core domain protein 2) are abnormally expressed in gynecological tumor tissues, they can be used as Tumor marker (TM) in serological determination (Laidi et al 2016; Simmons et al 2013; Tchou et al 2015)
HER-2 detection plays a pivotal role in the treatment choice, prognosis evaluation, and efficacy prediction of HER-2-positive breast cancer patients (Waks and Winer 2019)
Summary
Women’s health is related to themselves and to their families. In recent decades, the cancer incidence rate in female has risen significantly by 2.2% per year in China (Chen et al 2016). HE4 is associated with cancer cell adhesion, migration, and tumor growth. It could activate the MAPK and FOCAL adhesion signaling pathways, promoting ovarian cancer cell invasion and metastasis in ovarian cancer progression (Lu et al 2012; Zhuang et al 2014). This TM is negative in normal ovarian epithelium, and low in normal, benign tumor and adjacent tissues, but high in cancer (Ferraro et al 2013; Ferraro et al 2015; Simmons et al 2013). The national institutes of health regarded it as an important tool to screen patients with pelvic mass for benign and malignant diseases (Simmons et al 2013)
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