title: [The values of serum human epididymis secretory protein 4 and CA(125) assay in the diagnosis of ovarian malignancy].
abstract: OBJECTIVE
  To evaluate the value of human epididymis secretory protein 4 (HE4) and CA(125) in the diagnosis of ovarian malignancy.
  
  
  METHODS
  HE4 and CA(125) in the serum specimens of malignant ovarian tumor group (30 cases), benign ovarian diseases (110 cases; 45 benign ovarian tumor, 57 endometriotic diseases and 8 pelvic inflammation were included) and healthy women group (137 cases) were assayed double blindly. The levels and the diagnosis efficiency of the HE4 and CA(125) were analyzed.
  
  
  RESULTS
  (1) The median levels of HE4 and CA(125) were significantly higher in malignant ovarian tumor group (244 pmol/L and 601 kU/L respectively) than those of the benign ovarian diseases group (32 pmol/L and 22 kU/L respectively) and healthy women group (32 pmol/L and 11 kU/L respectively) (P = 0.000 - 0.029). The median levels of CA(125) were also higher in endometriotic diseases and pelvic inflammation groups (53 and 41 kU/L respectively) than those of benign ovarian tumor group and healthy women group (12 and 11 kU/L respectively; P = 0.000 - 0.031). (2) The positive rate of HE4 was lower than that of CA(125) in malignant ovarian tumor group (P = 0.036). HE4 was negative in benign diseases and healthy women groups. But the positive rates of CA(125) were 56.1% and 5/8 respectively in endometriotic diseases and pelvic inflammation groups and there were significant differences compared with HE4 (P = 0.000). (3) The HE4 assay had advantage over the CA(125) assay in receiver operating characteristic-area under the curve (ROC-AUC) and sensitivity with a specificity of 100% when ovarian malignancy was compared with controls having benign diseases and healthy women, benign tumor or benign diseases groups respectively. The CA(125) assay had advantage over the HE4 assay in ROC-AUC and sensitivity with the same specificity when ovarian cancers were compared with controls having healthy women group. (4) Combined assay of HE4 and CA(125) was better than CA(125) alone when ovarian malignancy was compared with controls having any group. (5) Combined assay was better than HE4 alone in ROC-AUC and sensitivity with the same specificity when ovarian cancers were compared with controls having benign diseases and healthy women or healthy women groups. And combined assay was lower in the ROC-AUC and the sensitivity with specificity of 100% than HE4 when ovarian cancers were compared with controls having benign tumors or benign diseases groups respectively. (6) The diagnosis efficiency of the HE4 assay at the level 86 pmol/L determined in ROC curve with controls having benign diseases and healthy women group and at the 95% reference level 50 pmol/L of healthy women or 150 pmol/L recommended by the kit respectively was compared. The sensitivity of 50 pmol/L was 73% higher than 150 pmol/L and 86 pmol/L, while the specificity and positive predictive value were lower (P = 0.002, P = 0.000). The specificity, accuracy and positive predictive value of HE4 assay at the set point of 150 pmol/L and 86 pmol/L were 100%, 96% and 96%. The set point of 86 pmol/L had advantage over 150 pmol/L at the sensitivity of diagnosis, 70% and 63% respectively. But the positive predictive value was 95% lower than 150 pmol/L, being 100%. There was no significant difference (P = 0.883, P = 0.883).
  
  
  CONCLUSIONS
  The specificity of HE4 assay is higher than CA(125) assay in the diagnosis of ovarian cancer and HE4 combined with CA(125) assay can improve the diagnoses. The set point of 150 pmol/L is advantageous for the accurate diagnosis, while the set point of 86 pmol/L is advantageous for the screening of malignant ovarian cancer.
authors.affiliation: Gynecologic Oncology Center, Peking University People's Hospital, Beijing 100044, China.
authors.forename: Li
authors.initials: L
authors.lastname: Dong
authors.forename: Xiao-Hong
authors.initials: XH
authors.lastname: Chang
authors.forename: Xue
authors.initials: X
authors.lastname: Ye
authors.forename: Li-Rong
authors.initials: LR
authors.lastname: Zhu
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhao
authors.forename: Li
authors.initials: L
authors.lastname: Tian
authors.forename: Hong-Yan
authors.initials: HY
authors.lastname: Cheng
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Li
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.forename: Qin-Ping
authors.initials: QP
authors.lastname: Liao
authors.forename: Tian-Yun
authors.initials: TY
authors.lastname: Fu
authors.forename: Ye-Xia
authors.initials: YX
authors.lastname: Cheng
authors.forename: Heng
authors.initials: H
authors.lastname: Cui
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019540:Area Under Curve; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000097:blood*; D016022:Case-Control Studies; D004311:Double-Blind Method; D004715:Endometriosis / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D030501:Epididymal Secretory Proteins / Q000032:analysis*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000097:blood / Q000175:diagnosis*; D010386:Pelvic Neoplasms / Q000097:blood; D012372:ROC Curve; D012680:Sensitivity and Specificity; D055815:Young Adult; D023083:beta-Defensins
chemical_list: D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; C426184:DEFB126 protein, human; D030501:Epididymal Secretory Proteins; D023083:beta-Defensins