title: Comparison of methods trial for high-risk HPV.
abstract: In efforts to improve service, we compared the performance of four methods of HPV detection: Invader HPV (Hologic), Hybrid Capture 2 (Qiagen), Inform HPV detection (Ventana), and standard PCR.Using blinded/de-identified cervical samples in Preservcyt (Hologic), we compared Ventana's Inform HPV Test, against Hologic's HPV Invader and PCR. In a separate evaluation, we compared Inform versus Invader versus hc2. Ventana employs in situ hybridization; Hologic's technology uses three specifically designed oligonucleotides and a fluorescent signal for detection. Qiagen's hc2 method incorporates enzyme-linked antibody detection of RNA-DNA hybrids. PCR testing was provided by Access Genetics (Minneapolis, MN). The United States Food and Drug Administration recently approved the Third Wave/Hologic Invader HPV high-risk test (rebranded as Cervista HPV HR Test).In this small study, involving a few hundred tests, Third Wave, Qiagen, and PCR tests were comparable. Kappa statistics comparing Third Wave to PCR and Third Wave to Qiagen were 0.88 and 0.74, respectively. Ventana's method did not correlate well with any of the other methods with Kappa's ranging from a low of 0.25 versus Qiagen to 0.31 versus PCR. Kappa statistics measure correlation and not accuracy of measurement.Although we felt that the specificity of our original HPV method, Ventana Inform was satisfactory and lowered our subsequent colposcopy rate, worries about its lower sensitivity caused us to look at other techniques. Other methods, PCR, hc2, and Invader, appeared comparable with one another in our series. We chose to implement the Third Wave test in our laboratory.
authors.affiliation: Wisconsin State Laboratory of Hygiene, University of Wisconsin-Madison, Madison, Wisconsin, USA. dkurtycz@wisc.edu
authors.forename: Daniel F I
authors.initials: DF
authors.lastname: Kurtycz
authors.forename: Michele
authors.initials: M
authors.lastname: Smith
authors.forename: Rong
authors.initials: R
authors.lastname: He
authors.forename: Kayo
authors.initials: K
authors.lastname: Miyazaki
authors.forename: John
authors.initials: J
authors.lastname: Shalkham
mesh_terms: D003581:Cytodiagnosis / Q000379:methods*; D004279:DNA, Viral / Q000032:analysis; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D017403:In Situ Hybridization; D030361:Papillomavirus Infections / Q000175:diagnosis*; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic