A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off

Abstract

BackgroundHigh-risk human papillomavirus (HR HPV) testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical pre-cancer and cancer.MethodsWe report a purely observational study evaluating HR HPV prevalences in residual liquid-based cytology (LBC) samples using both the Cervista™ HPV HR Test and the Digene Hybrid Capture 2 High-Risk HPV DNA Test (HC2) in a sample of 1,741 women aged ≥30 years of a German routine screening population of 13,372 women. Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.ResultsThe overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8). Relative sensitivities for the detection of histologically confirmed severe cervical intraepithelial dysplasia (CIN3+) were similar for both HPV-tests, which was confirmed by the ratio analysis. However, discrepancy analysis between the Cervista HPV HR test and HC2 revealed a high false positive rate of the Cervista HPV HR test in the cytology normal category.ConclusionsPerformance of the Cervista HPV test in cervical specimens with abnormal cytology is comparable to HC2 as both tests were highly sensitive and specific for the detection of high grade cervical disease. We also demonstrate evidence that modification of the cut-off values drastically reduces the false positive rate in the cytology normal category without affecting the detection of CIN3+, which ultimately improved specificity of the Cervista HPV HR assay.Electronic supplementary materialThe online version of this article (doi:10.1186/s12879-014-0674-1) contains supplementary material, which is available to authorized users.

Head-to-Head Comparison of the RNA-Based Aptima Human Papillomavirus (HPV) Assay and the DNA-Based Hybrid Capture 2 HPV Test in a Routine Screening Population of Women Aged 30 to 60 Years in Germany

“…All samples were first analyzed by LBC. LBC results were evaluated according to the Munich nomenclature II and were translated into the Bethesda System (TBS) as described previously (19,20). LBC results were considered negative when the result was Pap I/II (equivalent to negative for intraepithelial lesion or malignancy [NILM]) or Pap IIw (equivalent to inadequate or atypical cells of undetermined significance [ASCUS]); all other results were considered positive and resulted in referral for colposcopy.…”

“…Digene Hybrid Capture 2 high-risk HPV DNA (Qiagen, Hilden, Germany) testing was performed as described previously (20), using the Rapid Capture System 1 (RCS-1) according to the instructions. A cutoff value of relative light units/cutoff (RLU/CO) ratio of 1, equivalent to 1 pg of HPV DNA per 1 ml of sampling buffer, for positive test results was used in this study.…”

Study-based evaluation of the Abbott RealTime High Risk HPV test in comparison to the HC2 HR HPV test in women aged ≥30 years using residual LBC ThinPrep specimens

“…Sample Collection has previously been described [24]. Briefly cervical samples were collected in LBC PreservCyt® Collection medium (Hologic) using the Cervex broom according to routine guidelines.…”

“…LBC was performed as described before [24] by the ThinPrep® 2000 Processor (Hologic) following the manufacturer’s instructions. Cytology results were reported using the Munich Nomenclature II and were translated into The Bethesda System (TBS) ([25]; Table 1).…”

“…Cytology results were reported using the Munich Nomenclature II and were translated into The Bethesda System (TBS) ([25]; Table 1). LBC results were considered negative when the result was Pap I/II (Normal) or Pap IIw (ASC-US); all other results were considered positive [24]. …”