title: A new strategy for calculating the risk of ovarian malignancy algorithm (ROMA).
abstract: BACKGROUND
  Reliable quantitative measurements of HE4 and CA125 levels are required to calculate the risk of ovarian malignancy algorithm (ROMA) value. We suggest a new reporting strategy for interpreting ROMA values based on analytical measurement range (AMR) and qualified-intervals of the HE4 and CA125 results.
  
  
  METHODS
  HE4 and CA125 assays from Abbott and Roche were used. The AMRs and the qualified-intervals were as follows: Architect HE4 assay, 20-1500 and 17.2-2637.8 pmol/L; Architect CA125 II assay, 1-1000 and 3.9-14,163.0 U/mL; Elecsys HE4 assay, 15-1500 and 28.8-3847 pmol/L; Elecsys CA125 II assay, 0.6-5000 and 6.5-5000 U/mL. These values were used to simulate the ROMA values.
  
  
  RESULTS
  Reporting algorithm for the ROMA value could be classified into three categories. (1) If quantitative HE4 and CA125 levels are reliable, the numerical ROMA value can be reported. (2) If HE4 value is <20 and <28.8 for Abbott and Roche in premenopausal woman, the ROMA value should be reported as "low risk" regardless of the CA125 result. In postmenopausal woman, however, it should be reported as "low risk" (CA125<203.0 and <165.8 for Abbott and Roche) or "undetermined" (vice-versa value). (3) If CA125 value is <3.9 and <6.5 for Abbott and Roche, it should be reported as "low risk" (premenopausal HE4<51.5 and <62.2, postmenopausal HE4<323.0 and <281.5 for Abbott and Roche) or "undetermined" (vice-versa value).
  
  
  CONCLUSIONS
  New reporting strategy will provide more informative reporting of ROMA values in clinical practice.
authors.affiliation: .
authors.forename: Tae-Dong
authors.initials: TD
authors.lastname: Jeong
authors.affiliation: .
authors.forename: Eun-Jung
authors.initials: EJ
authors.lastname: Cho
authors.affiliation: .
authors.forename: Dae-Hyun
authors.initials: DH
authors.lastname: Ko
authors.affiliation: .
authors.forename: Woochang
authors.initials: W
authors.lastname: Lee
authors.affiliation: .
authors.forename: Sail
authors.initials: S
authors.lastname: Chun
authors.affiliation: .
authors.forename: Hi Jeong
authors.initials: HJ
authors.lastname: Kwon
authors.affiliation: .
authors.forename: Ki-Sook
authors.initials: KS
authors.lastname: Hong
authors.affiliation: .
authors.forename: Yong-Man
authors.initials: YM
authors.lastname: Kim
authors.affiliation: .
authors.forename: Won-Ki
authors.initials: WK
authors.lastname: Min
mesh_terms: D000465:Algorithms; D018394:CA-125 Antigen / Q000097:blood; D019295:Computational Biology / Q000379:methods*; D005260:Female; D006801:Humans; D008565:Membrane Proteins / Q000097:blood; D010051:Ovarian Neoplasms; D017698:Postmenopause / Q000097:blood; D017697:Premenopause / Q000097:blood; D011506:Proteins / Q000032:analysis; D018570:Risk Assessment / Q000379:methods*; D000081102:WAP Four-Disulfide Core Domain Protein 2
chemical_list: D018394:CA-125 Antigen; C451759:MUC16 protein, human; D008565:Membrane Proteins; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human
keywords: CA125; HE4; quantitative measurement; risk of ovarian malignancy algorithm