Diagnostic accuracy of haptoglobin within ovarian cyst fluid as a potential point‐of‐care test for epithelial ovarian cancer: an observational study

• Published in: BJOG : an international journal of obstetrics and gynaecology 2018-03, Vol.125 (4), p.421-431
• Main Authors: Mahyuddin, AP, Liu, L, Zhao, C, Kothandaraman, N, Salto‐Tellez, M, Pang, BNK, Lim, DGS, Annalamai, L, Chan, JKY, Lim, TYK, Biswas, A, Rice, G, Razvi, K, Choolani, M
• Format: Article
• Language: English
• Subjects: Accuracy; Adult; Aged; Asia, Southeastern; Benign; Biomarker; Biomarkers; Biomarkers, Tumor - analysis; CA-125 Antigen - analysis; Carcinoma, Ovarian Epithelial - diagnosis; Carcinoma, Ovarian Epithelial - pathology; Carcinoma, Ovarian Epithelial - surgery; Cohort Studies; Colorimetry; Cyst Fluid - diagnostic imaging; Cysts; Diagnosis, Differential; Diagnostic tests; Dimensional Measurement Accuracy; Enzyme-linked immunosorbent assay; epithelial ovarian cancer; Female; frozen section; Frozen Sections - methods; Haptoglobin; Haptoglobins - analysis; Health risk assessment; Humans; Immunohistochemistry; Intraoperative Care - methods; in vitro diagnostic; Malignancy; Medical diagnosis; Middle Aged; Observational studies; Ovarian cancer; Ovarian Cysts - diagnosis; Ovarian Cysts - pathology; Ovarian Neoplasms - diagnosis; Ovarian Neoplasms - pathology; Ovarian Neoplasms - surgery; Point-of-Care Testing; point‐of‐care; Population studies; Proteomics - methods; Sensitivity and Specificity
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/1471-0528.14835

Objective To investigate haptoglobin within ovarian cyst fluid (OCF) as a diagnostic biomarker for epithelial ovarian cancer (EOC) and develop an in vitro diagnostic point‐of‐care device test (IVDPCT) for use in the operating theatre. Design Retrospective and prospective cohort study. Setting South‐East Asia. Population Women with suspicious ovarian cysts. Methods Proteomic, immunohistochemical and ELISA methods measured haptoglobin in OCF to differentiate benign and EOCs. Diagnostic performance of haptoglobin was compared with CA125, risk malignancy indices (RMI) and frozen section. Blinded validation of the IVDPCT was performed. Main outcome measures Prediction of malignancy. Results Haptoglobin concentration measured by ELISA was 0.70 ± 0.09 mg/ml in patients with benign cysts (n = 87), 6.22 ± 0.53 mg/ml in early stage‐EOC (n = 17), and 6.57 ± 0.65 mg/ml in late stage‐EOC (n = 20). Haptoglobin in EOCs was significantly higher than in benign cysts (P