title: Multimodal hyperspectroscopy as a triage test for cervical neoplasia: pivotal clinical trial results.
abstract: OBJECTIVE
  To prospectively evaluate a new non invasive device that combines fluorescence and reflectance spectroscopy in a population in women at risk for cervical dysplasia.
  
  
  METHODS
  A total of 1607 women were evaluated with multimodal hyperspectroscopy (MHS), a painless test with extremely high spectral resolution. Subjects who were referred to colposcopy based on abnormal screening tests or other referral criteria underwent the MHS test and also had a sample taken for additional cytology and presence of high risk human papilloma virus (HPV) prior to undergoing biopsy.
  
  
  RESULTS
  Sensitivity of MHS for cervical intraepithelial neoplasia (CIN) 2+ was 91.3% (252/276). Specificity, or the potential reduction in referrals to colposcopy and biopsy, was 38.9% (222/570) for women with normal or benign histology and 30.3% (182/601) for women with CIN1 histology. Two year follow-up data, collected for a subgroup of 804 women, revealed 67 interval CIN2+ that originally were diagnosed at enrollment as normal or CIN1. MHS identified 60 of these (89.6%) as positive for CIN2+ prior to their discovery during the two year follow-up period.
  
  
  CONCLUSIONS
  MHS provides an immediate result at the point of care. Recently, the limitations of cytology have become more obvious and as a consequence greater emphasis is being placed on HPV testing for cervical cancer screening, creating a need for an inexpensive, convenient and accurate test to reduce false positive referrals to colposcopy and increase the yield of CIN2+ at biopsy. MHS appears to have many of the attributes necessary for such an application.
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL 33136, USA. LTwiggs@med.miami.edu
authors.forename: Leo B
authors.initials: LB
authors.lastname: Twiggs
authors.forename: Nahida A
authors.initials: NA
authors.lastname: Chakhtoura
authors.forename: Daron G
authors.initials: DG
authors.lastname: Ferris
authors.forename: Lisa C
authors.initials: LC
authors.lastname: Flowers
authors.forename: Marc L
authors.initials: ML
authors.lastname: Winter
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Sternfeld
authors.forename: Manocher
authors.initials: M
authors.lastname: Lashgari
authors.forename: Alexander F
authors.initials: AF
authors.lastname: Burnett
authors.forename: Stephen S
authors.initials: SS
authors.lastname: Raab
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Wilkinson
mesh_terms: D000293:Adolescent; D000328:Adult; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D006801:Humans; D055095:Optics and Photonics / Q000379:methods; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000473:pathology; D011446:Prospective Studies; D013050:Spectrometry, Fluorescence / Q000379:methods*; D013057:Spectrum Analysis / Q000379:methods; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000473:pathology / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology / Q000821:virology; D055815:Young Adult