title: [Diagnostic value of combining detection of human epididymis protein 4 and CA125 in patients with malignant ovarian carcinoma].
abstract: OBJECTIVE
  To investigate the clinical value of combination of human epididymis protein 4 (HE4), CA125 and the Risk of Ovarian Malignancy Algorithm (ROMA) in diagnosis of ovarian carcinoma.
  
  
  METHODS
  To detect the serum concentration of HE4 using ELISA and CA125 using ECL in patients of ovarian carcinoma group (n = 119), borderline ovarian tumor group (n = 36), benign ovarian neoplasm group (n = 96) and female healthy control group (n = 53). The ROMA based on the serum level of CA125, HE4 and a woman's menopausal status was used to calculate the predicted probability (PP) and diagnostic results of ovarian cancers.
  
  
  RESULTS
  The receiver operating characteristic (ROC) analysis showed the cut-off value was 67.3 pmol/L (the AUC was 0.906, the sensitivity was 80.7% and specificity was 94.6%). The serum levels of HE4 and CA125 in the ovarian carcinoma group were significantly higher than that in the borderline ovarian tumor group, benign ovarian neoplasm group and female healthy control group (P < 0.01). The serum levels of CA125 and HE4 showed statistically no significant difference between the borderline ovarian tumor group and benign ovarian neoplasm group (P > 0.05). The levels of HE4 and CA125 were reduced significantly in ovarian patients after surgery therapy (P < 0.01). The sensitivity and specificity of HE4 + CA125 combination was 92.7% and 72.5%. The ROMA that can classify patients into high and low risk groups was established as 9.3% in premenopausal and 27.3% in postmenopausal women.
  
  
  CONCLUSIONS
  HE4 is a helpful biomarker for ovarian carcinoma diagnosis. Biomarker combination of HE4 and CA125, and applying of the ROMA are helpful to improve the accuracy in diagnosis of ovarian cancers.
authors.affiliation: Clinical Laboratory, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Min-jie
authors.initials: MJ
authors.lastname: Wang
authors.forename: Jun
authors.initials: J
authors.lastname: Qi
authors.forename: Hai
authors.initials: H
authors.lastname: Wang
authors.forename: Xue-xiang
authors.initials: XX
authors.lastname: Li
authors.forename: Bao-jun
authors.initials: BJ
authors.lastname: Wei
authors.forename: Chao
authors.initials: C
authors.lastname: Fu
authors.forename: Jia
authors.initials: J
authors.lastname: Gao
authors.forename: Bin-Bin
authors.initials: BB
authors.lastname: Han
mesh_terms: D002288:Adenocarcinoma, Mucinous / Q000097:blood / Q000175:diagnosis / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D014408:Biomarkers, Tumor / Q000097:blood; D018394:CA-125 Antigen / Q000097:blood*; D018284:Cystadenocarcinoma, Serous / Q000097:blood / Q000175:diagnosis* / Q000601:surgery; D018293:Cystadenoma, Serous / Q000097:blood / Q000175:diagnosis / Q000601:surgery; D004715:Endometriosis / Q000097:blood / Q000175:diagnosis; D005260:Female; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000097:blood / Q000175:diagnosis* / Q000601:surgery; D011506:Proteins / Q000378:metabolism*; D012372:ROC Curve; D012680:Sensitivity and Specificity; D013724:Teratoma / Q000097:blood / Q000175:diagnosis / Q000601:surgery; D000081102:WAP Four-Disulfide Core Domain Protein 2; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human