title: SurePath Specimens Versus ThinPrep Specimen Types on the COBAS 4800 Platform: High-Risk HPV Status and Cytology Correlation in an Ethnically Diverse Bronx Population.
abstract: OBJECTIVE
  To compare the cytologic preparations of 130 cervical specimens (from women of various ethnicities at high risk for human papillomavirus [HPV] infection) using the SurePath (SP) collection system with specimens gathered using the ThinPrep (TP) system, as processed on the Cobas 4800 analyzer, to determine which collection method more accurately identifies HPV infection.
  
  
  METHODS
  In our prospective study, specimens were collected from 130 women of various ethnicities residing in or near Bronx County, NY. The SP-collected specimen was first processed for cytologic findings; if clinical HPV testing was requested on that specimen, it was tested using Hybrid Capture II (HC2) methodology. We tested the remnant SP-collected cell concentrate using the Cobas analyzer. Then, the TP-collected and SP-collected specimens were tested in the same run on that analyzer, and the results were compared. We also compared the results with the concurrent cytologic findings.
  
  
  RESULTS
  The results were concordant for overall HR-HPV status in 93.8% of cases. Also, a statistically significant lower cycle threshold value was observed with Cobas testing of specimen concentrates tested via the BD SurePath Pap Test (P = .001), suggesting higher sensitivity compared with specimens tested via the ThinPrep Pap Test.
  
  
  CONCLUSIONS
  Cobas 4800 HPV testing of SP-collected specimen concentrates yields comparable results to TP-collected specimen concentrates. Based on the limited data that we derived, SP collection may be a more favorable methodology than TP collection for HPV testing of individuals at high risk in our ethnically diverse, urban patient population.
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: R C
authors.initials: RC
authors.lastname: Naeem
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: D Y
authors.initials: DY
authors.lastname: Goldstein
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Einstein
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: G
authors.initials: G
authors.lastname: Ramos Rivera
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: K
authors.initials: K
authors.lastname: Schlesinger
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: S N
authors.initials: SN
authors.lastname: Khader
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: M
authors.initials: M
authors.lastname: Suhrland
authors.affiliation: Department of Pathology, Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.
authors.forename: A S
authors.initials: AS
authors.lastname: Fox
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D003581:Cytodiagnosis / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D009519:New York City; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D014626:Vaginal Smears / Q000379:methods*; D055815:Young Adult
keywords: Cobas 4800 HPV genotyping; HPV screening; HPV testing comparison; HPV testing in diverse population; NY State off-label LDT approval; SurePath and ThinPrep cytologic testing