title: Determination of reference intervals of serum levels of human epididymis protein 4 (HE4) in Chinese women.
abstract: BACKGROUND
  To determine reference intervals for serum levels of human epididymis protein 4 (HE4) in Chinese women.
  
  
  METHODS
  In this multicenter (n = 9) study, 618 healthy women, 767 patients with non-malignant diseases, and 951 patients with malignant tumors were enrolled. Serum levels of HE4 were measured in all patients using electrochemiluminescence immunoassays. The influence of age, menopause, malignancy status and other characteristics on the levels of HE4 was evaluated using univariate and multivariate analyses. Confidence intervals (2.5-97.5 %) were determined in different populations.
  
  
  RESULTS
  There were significant differences in HE4 levels among groups with different ages, menopause or malignancy status. Higher levels of HE4 were detected in elder compared to younger, post- compare to pre- menopause and malignant compared to benign subjects. Multivariate analysis showed that menopause and malignancy status, as well as smoking and pelvic masses were independent factors involved in serum HE4 levels. In pre-menopause stage, the reference ranges of HE4 level were 29.30-68.79, 28.12-1284.83 and 34.75-981.91 pmol/L in healthy, benign and malignant populations, respectively. In post-menopause stage, the reference ranges are 35.96-114.43, 39.11-2208.70 and 39.40-1678.13 pmol/L for those populations.
  
  
  CONCLUSIONS
  The present study has established the reference intervals of HE4 levels in pre- and post-menopause populations with different malignancy status.
authors.affiliation: Department of Clinical Biochemistry, Chinese PLA General Hospital, Beijing, 100853, China. tianyp61@126.com.
authors.forename: Yaping
authors.initials: Y
authors.lastname: Tian
authors.affiliation: Department of Clinical Laboratory, Qilu Hospital of Shandong University, Jinan, 250012, Shandong Province, China. wcx6601@126.com.
authors.forename: Chuanxin
authors.initials: C
authors.lastname: Wang
authors.affiliation: Laboratory Medicine Department, Tongji Hospital, Tongji Medical College of HUST, Wuhan, 430030, Hubei Province, China. chengliming2002@163.com.
authors.forename: Liming
authors.initials: L
authors.lastname: Cheng
authors.affiliation: Department of Clinical Laboratory, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China. zhangaimin_amy@yahoo.com.cn.
authors.forename: Aimin
authors.initials: A
authors.lastname: Zhang
authors.affiliation: Department of Clinical Laboratory, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, Guangdong Province, China. liuwen@sysucc.org.cn.
authors.forename: Wen
authors.initials: W
authors.lastname: Liu
authors.affiliation: Department of Clinical Laboratory, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. jykca@sina.com.
authors.forename: Lin
authors.initials: L
authors.lastname: Guo
authors.affiliation: Department of Clinical Laboratory, Zhongshan Hospital Xiamen University, Xiamen, 361004, Fujian Province, China. xmnorman@163.com.
authors.forename: Huiming
authors.initials: H
authors.lastname: Ye
authors.affiliation: Clinical Laboratory Center, Tumor Hospital Affiliated to Xinjiang Medical University, Urumqi, 830011, Xinjiang Province, China. huangyanchun0619@sohu.com.
authors.forename: Yanchun
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Department of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, Fujian Province, China. chenear9040@sina.com.
authors.forename: Jing
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Clinical Biochemistry, Chinese PLA General Hospital, Beijing, 100853, China. wendy36500@yahoo.com.cn.
authors.forename: Xinyu
authors.initials: X
authors.lastname: Wen
authors.affiliation: Department of Clinical Biochemistry, Chinese PLA General Hospital, Beijing, 100853, China. xingyl84@163.com.
authors.forename: Yuelei
authors.initials: Y
authors.lastname: Xing
authors.affiliation: Department of Clinical Laboratory, Qilu Hospital of Shandong University, Jinan, 250012, Shandong Province, China. qiluzgx@163.com.
authors.forename: Guixi
authors.initials: G
authors.lastname: Zheng
authors.affiliation: Laboratory Medicine Department, Tongji Hospital, Tongji Medical College of HUST, Wuhan, 430030, Hubei Province, China. ziyongsun@hotmail.com.
authors.forename: Ziyong
authors.initials: Z
authors.lastname: Sun
authors.affiliation: Laboratory Medicine Department, Tongji Hospital, Tongji Medical College of HUST, Wuhan, 430030, Hubei Province, China. tjhsncs@126.com.
authors.forename: Huijun
authors.initials: H
authors.lastname: Li
authors.affiliation: Department of Clinical Laboratory, Tianjin Medical University Cancer Institute & Hospital, Tianjin, 300060, China. laopang.56@163.com.
authors.forename: Peng
authors.initials: P
authors.lastname: Zhang
authors.affiliation: Department of Clinical Laboratory, Sun Yat-Sen University Cancer Center, Guangzhou, 510060, Guangdong Province, China. liuwl@mail.sysu.edu.com.cn.
authors.forename: Wanli
authors.initials: W
authors.lastname: Liu
authors.affiliation: Department of Clinical Laboratory, Fudan University Shanghai Cancer Center, Shanghai, 200032, China. 1251487447@qq.com.
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Department of Clinical Laboratory, Zhongshan Hospital Xiamen University, Xiamen, 361004, Fujian Province, China. zhangzy1121@yahoo.com.cn.
authors.forename: Zhongying
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Clinical Laboratory Center, Tumor Hospital Affiliated to Xinjiang Medical University, Urumqi, 830011, Xinjiang Province, China. 534428398@qq.com.
authors.forename: Yi
authors.initials: Y
authors.lastname: Xu
authors.affiliation: Clinical Laboratory Center, Tumor Hospital Affiliated to Xinjiang Medical University, Urumqi, 830011, Xinjiang Province, China. 158719972@qq.com.
authors.forename: Yishan
authors.initials: Y
authors.lastname: Huo
authors.affiliation: Department of Laboratory Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, 350005, Fujian Province, China. ouqishui@163.com.
authors.forename: Qishui
authors.initials: Q
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mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People / Q000208:ethnology; D000077216:Carcinoma, Ovarian Epithelial; D002681:China / Q000208:ethnology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000097:blood* / Q000208:ethnology; D010051:Ovarian Neoplasms / Q000097:blood* / Q000208:ethnology; D017698:Postmenopause / Q000097:blood; D017697:Premenopause / Q000097:blood; D011446:Prospective Studies; D011506:Proteins / Q000378:metabolism*; D012016:Reference Values; D000081102:WAP Four-Disulfide Core Domain Protein 2; D055815:Young Adult
chemical_list: D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human