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

To investigate haptoglobin within ovarian cyst fluid (OCF) as a diagnostic biomarker for epithelial ovarian cancer (EOC) and develop an in\ua0vitro diagnostic point-of-care device test (IVDPCT) for use in the operating theatre.Retrospective and prospective cohort study.South-East Asia.Women with suspicious ovarian cysts.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.Prediction of malignancy.Haptoglobin concentration measured by ELISA was 0.70\ua0±\ua00.09\ua0mg/ml in patients with benign cysts (n\ua0=\ua087), 6.22\ua0±\ua00.53\ua0mg/ml in early stage-EOC (n\ua0=\ua017), and 6.57\ua0±\ua00.65\ua0mg/ml in late stage-EOC (n\ua0=\ua020). Haptoglobin in EOCs was significantly higher than in benign cysts (P\ua