Tissue ELISA and Serum Amperometric Magnetoimmunosensor of ECD-HER2 In Stratifying Subtyping of Egyptian Woman Breast Cancers

Nakhla, Sameh Fawzy; Elwafe, Zynab; Saad, Ahmed Saad; Aref, Tarek; Ragab, Noha; Elbadry, Inas; Eletxigerra, Unai Eletxigerra; Campuzano, Susana; Mart&iacute;nez-Perdiguero, Jesus; Merino, Santos Merino; M. Pingarr&oacute;n, Jos&eacute;; Abdelmoneim, Salah; El-Abd, Eman

doi:10.21608/zumj.2022.161766.2643

Tissue ELISA and Serum Amperometric Magnetoimmunosensor of ECD-HER2 In Stratifying Subtyping of Egyptian Woman Breast Cancers

Document Type : Original Article

Authors

¹ Radiation Sciences department, Medical Research Institute (MRI), Alexandria University, Alexandria, Egypt.

² 2. Radiology Department, Faculty of Medical Technology, Derna, Libya

³ Experimental and Clinical Surgery Department, MRI, Alexandria University, Alexandria, Egypt.

⁴ Radiodiagnosis Department, MRI, Alexandria University, Alexandria, Egypt.

⁵ Department of Pathology, MRI, Alexandria University, Alexandria, Egypt

⁶ Department of Cancer Management and Research, MRI, Alexandria University, Alexandria, Egypt

⁷ Micro-NanoFabrication Unit, IK4-Tekniker, Eibar, Spain

⁸ Departamento de Química Analítica, Facultad de CC. Químicas, Universidad Complutense de Madrid, Madrid, Spain.

⁹ Universidad del País Vasco/Euskal Herriko Unibertsitatea, Bizkaia, Spain.

¹⁰ Department of Clinical Oncology and Nuclear Medicine, faculty of medicine, AlexandriaUniversity, Alexandria, Egypt.

10.21608/zumj.2022.161766.2643

Abstract

Background: Detection of HER2 extracellular domain (ECD) amperometric magnetoimmunosensor (AM) investigated on raw cell lysates, intact breast cancer cells, and commercial and healthy sera except on patients' samples.
Aim: The current study aimed to validate tissue and serum AM of ECD-HER2 in subtyping Egyptian woman breast cancers and to compare it to the current techniques.
Subjects and Methods: We collected blood and tissues from 72 women (20 controls, five recurrent breast tumors, and 47 BCs). Tissue (tHER2) and serum HER2 (sHER2); are detected by ELISA and the AM. Results correlated with the clinicopathological parameters, and serum CA15-3 (sCA15-3).
Results: tHER2 (ELISA) and sCA15-3 significantly differed among the studied groups. tHER2 (ELISA) showed a significant decrease in higher BMI in the HER22+ group, while tHER2 and sHER2 (AM) significantly correlated in the HER23+ group. tHER2 (ELISA) significantly differed among BCs molecular subtypes. Both tHER2 and sHER2 (ELISA) significantly correlated in the HER2 molecular subgroup. sHER2 (AM) showed highly significant sensitivity and specificity in differentiating TN from luminal A at > 9.26 ng/ml and HER2 at 9.6 ng/ml. However, at > 1.67 ng/ml, tHER2 (ELISA) stratified significantly between BCs molecular and HER2 subgroups.
Conclusion: Tissue ELISA and serum AM provided accurate quantitative measurements for HER2 in various BC subtypes—at cut-off values lower than those approved by FDA—and would complement the current IHC and ISH techniques.

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