title: Comparing the Performance of Hybrid Capture II and Polymerase Chain Reaction (PCR) for the Identification of Cervical Dysplasia in the Screening and Diagnostic Settings.
abstract: OBJECTIVE
  Both PCR and Hybrid Capture II (HCII) have been used for identifying cervical dysplasia; however, comparisons on the performance between these two tests show inconsistent results. We evaluated the performance of HCII and PCR MY09/11 in both screening and diagnostic populations in sub-sample of 1,675 non-pregnant women from a cohort in three clinical centers in the United States and Canada.
  
  
  METHODS
  Sensitivity, specificity, positive predictive value, negative predictive value, and concordance between the two tests were calculated.
  
  
  RESULTS
  Specificity of HCII in detecting low-grade squamous intraepithelial lesion (LSIL) was higher in the screening group (88.7%; 95% CI: 86.2%-90.8%) compared to the diagnostic group (46.3%; 95% CI: 42.1%-50.6%); however, specificity of PCR was low in both the screening (32.8%; 95% CI: 29.6%-36.2%) and diagnostic (14.4%; 95% CI: 11.6%-17.6%) groups. There was comparable sensitivity by both tests in both groups to detect high-grade squamous intraepithelial lesion (HSIL); however, HCII was more specific (89.1%; 95% CI: 86.8%-91.0%; 66.2%; 95% CI: 62.0%-70.1%) than PCR (33.3%; 95% CI: 30.2%-36.5%; 17.9%; 95% CI: 14.8%-21.6%) in the screening and diagnostic groups, respectively. Overall agreement for HPV positivity was approximately 50% between HCII and PCR MY09/11; with more positive results coming from the PCR MY09/11.
  
  
  CONCLUSIONS
  In the current study, PCR MY09/11 was more sensitive but less specific than HCII in detecting LSIL, and HCII was more sensitive and specific in detecting HSIL than PCR in both screening and diagnostic groups.
authors.affiliation: Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, Texas, USA. ; Division of Epidemiology, Human Genetics, and Environmental Sciences, School of Public Health, the University of Texas Health Science Center-Houston, Texas, USA.
authors.forename: Hung N
authors.initials: HN
authors.lastname: Luu
authors.forename: Karen
authors.initials: K
authors.lastname: Adler-Storthz
authors.forename: Laura M
authors.initials: LM
authors.lastname: Dillon
authors.forename: Michele
authors.initials: M
authors.lastname: Follen
authors.forename: Michael E
authors.initials: ME
authors.lastname: Scheurer
keywords: cervical dysplasia; comparison; hybrid capture II (HC II); polymerase chain reaction (PCR); test accuracy