title: Clinical performance of two multi-marker blood tests for predicting malignancy in women with an adnexal mass.
abstract: BACKGROUND
  Reliable methods that allow appropriate triage of women with an adnexal mass to a gynecologic oncologist are needed. We evaluated the clinical performance of OVA1 and ROMA for the prediction of malignancy in women with an adnexal mass.
  
  
  METHODS
  One hundred forty-six prospectively collected serum samples were collected from women with an adnexal mass, 31 of whom had surgically confirmed malignancies. OVA1 and ROMA tests were performed on all samples. Receiver operating characteristic curve analysis was used to determine interpretive cutoffs for ROMA. Performance characteristics of both tests were determined and compared.
  
  
  RESULTS
  The sensitivity of OVA1 and ROMA was 97% and 87%, respectively (p=0.25). ROMA was more specific than OVA1 (83% vs. 55%, respectively; p<0.0001). The negative predictive values of both tests were similar (98.4% and 96.0%, respectively). ROMA performed on all patients identified as high risk by OVA1 (a sequential strategy) produced a positive predictive value of 69%.
  
  
  CONCLUSIONS
  OVA1 and ROMA have similar performance characteristics, with OVA1 having non-significant greater diagnostic sensitivity and ROMA having greater diagnostic specificity. The use of these tests to appropriately triage women with an adnexal mass should be gauged within the context of their respective limitations. A sequential testing strategy may improve overall performance.
authors.affiliation: Department of Pathology, University of Utah School of Medicine, 15 North Medical Drive, Salt Lake City, UT 84112, United States. Electronic address: david.grenache@path.utah.edu.
authors.forename: David G
authors.initials: DG
authors.lastname: Grenache
authors.affiliation: Department of Pathology, University of Utah School of Medicine, 15 North Medical Drive, Salt Lake City, UT 84112, United States.
authors.forename: Karen A
authors.initials: KA
authors.lastname: Heichman
authors.affiliation: Department of Medicine, Division of Oncology, University of Utah School of Medicine, 15 North Medical Drive, Salt Lake City, UT 84112, United States.
authors.forename: Theresa L
authors.initials: TL
authors.lastname: Werner
authors.affiliation: Fujirebio Diagnostics, Inc., 201 Great Valley Parkway, Malvern, PA 19355, United States.
authors.forename: Zivjena
authors.initials: Z
authors.lastname: Vucetic
mesh_terms: D000290:Adnexa Uteri / Q000378:metabolism* / Q000473:pathology; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D016632:Apolipoprotein A-I / Q000097:blood; D014408:Biomarkers, Tumor / Q000097:blood*; D018394:CA-125 Antigen / Q000097:blood; D000077216:Carcinoma, Ovarian Epithelial; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000097:blood* / Q000175:diagnosis* / Q000473:pathology; D010051:Ovarian Neoplasms / Q000097:blood* / Q000175:diagnosis* / Q000473:pathology; D017698:Postmenopause; D011228:Prealbumin / Q000378:metabolism; D017697:Premenopause; D011379:Prognosis; D011446:Prospective Studies; D011506:Proteins / Q000378:metabolism; D012680:Sensitivity and Specificity; D014168:Transferrin / Q000378:metabolism; D000081102:WAP Four-Disulfide Core Domain Protein 2; D001613:beta 2-Microglobulin / Q000097:blood
chemical_list: D016632:Apolipoprotein A-I; D014408:Biomarkers, Tumor; D018394:CA-125 Antigen; D011228:Prealbumin; D011506:Proteins; D014168:Transferrin; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human; D001613:beta 2-Microglobulin
keywords: Adnexal mass; Multi-marker test; Ovarian cancer; Sensitivity and specificity