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-ofcare device test (IVDPCT) for use in the operating theatre.
Main outcome measures: Prediction of malignancyResults: In patients with benign cysts (n=87) haptoglobin concentration measured by ELISA was 0·70±0·09 mg/ml; early stage-EOC (n=17) was 6·22±0·53 mg/ml; and late stage-EOC (n=20) was 6·57±0·65 mg/ml. Haptoglobin in EOCs was significantly higher than benign
Accepted ArticleThis article is protected by copyright. All rights reserved.cysts (P<0·0001). Haptoglobin using rapid colorimetric assay (RCA) on a training set had sensitivity of 97·3% and specificity 92·0%, comparable to ELISA and frozen sections. The haptoglobin AUROC curve was 0·999 (95%CI 0·997-1·000) compared to 0·895 (95%CI 0·814-0·977, P<0·05) for CA125. Haptoglobin performed significantly better than all the RMIs (P<0·01). Blinded validation studies showed a minor drop in average diagnostic performance (sensitivity 85·2% and specificity 90·5%) compared to training set. However, when compared to frozen section, haptoglobin was no worse in diagnostic accuracy for malignancy.
Conclusion:Haptoglobin was identified as a biomarker for the detection of EOC with potential as a point-of-care diagnostic tool.
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