title: Analytical performance of the Investigational Use Only Cervista HPV HR test as determined by a multi-center study.
abstract: BACKGROUND
  Any HPV test designed to be utilized in cervical cancer screening programs should be highly validated both analytically and clinically.
  
  
  OBJECTIVE
  The Investigational Use Only (IUO) Cervista HPV HR test is designed to detect 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). The analytical performance of the Cervista HPV HR test was characterized in a multi-center study.
  
  
  RESULTS
  Analytical sensitivity for the 14 high-risk HPV types that the test is designed to detect ranged from 1,250 copies to 7,500 copies per reaction depending on HPV type. Accuracy compared to PCR with bi-directional sequencing was 91.4% [95% CI: 86.5 95.0%]. The reproducibility, when tested at three different testing centers, resulted in an overall inter-run reproducibility (between day/within site) agreement of 98.8% [1-sided 95% Confidence Lower Limit = 96.9%] and an overall inter-site reproducibility (between site) agreement of 98.7% [1-sided 95% Confidence Lower Limit = 97.9%]. The Cervista HPV HR test showed no cross-reactivity with DNA from seven non-oncogenic HPV types or 17 different infectious agents at up to 10(7) copies per reaction.
  
  
  CONCLUSIONS
  The analytical performance of the Cervista HPV HR test demonstrates sufficient analytical performance for use in cervical cancer screening. As with any clinical laboratory test, analytical characteristics must be evaluated in light of the clinical performance of this assay.
authors: Hologic, Inc., Madison, WI 53719, USA. Stephen.Day@Hologic.com
authors: Stephen P
authors: SP
authors: Day
authors: Angela
authors: A
authors: Hudson
authors: Andrea
authors: A
authors: Mast
authors: Tamara
authors: T
authors: Sander
authors: Michelle
authors: M
authors: Curtis
authors: Sarah
authors: S
authors: Olson
authors: LuAnne
authors: L
authors: Chehak
authors: Neil
authors: N
authors: Quigley
authors: Joellen
authors: J
authors: Ledford
authors: Belinda
authors: B
authors: Yen-Lieberman
authors: Debra
authors: D
authors: Kohn
authors: Denise I
authors: DI
authors: Quigley
authors: Marilyn
authors: M
authors: Olson
mesh_terms: D002584:Cervix Uteri / Q000821:virology*; D005260:Female; D006801:Humans; D008403:Mass Screening / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
chemical_list: D011933:Reagent Kits, Diagnostic