Comparison of the PapilloCheck® assay with the digene HC2 HPV DNA assay for the detection of 13 high-risk human papillomaviruses in cervical and anal scrapes.

ABSTRACT

The PapilloCheck® assay was compared with the Digene HC2 HPV DNA assay for the detection of 13 high-risk human papillomaviruses (HPV) in 240 samples, including 181 cervical scrapes and 59 anal scrapes. Overall, 75 (30.5%) samples were positive by the Digene HC2 HPV DNA assay 34 (18.8%) cervical scrapes and 41 (69.5%) anal scrapes. By considering only the 13 high-risk HPV types detected by the Digene HC2 HPV DNA assay, 66 (27.5%) samples were positive by the PapilloCheck® assay 27 (14.9%) cervical scrapes and 39 (66.1%) anal scrapes. Concordant results between the two assays were obtained for 225 (93.8%) samples with a Kappa coefficient value of 0.85, indicating an excellent agreement. By considering all the HPV types detectable by the PapilloCheck® assay, the overall prevalence of HPV was 34.2% (82/240) 21.0% (38/181) in cervical scrapes and 74.6% (44/59) in anal scrapes. Among the samples positive by the PapilloCheck® assay, a multiple HPV infection (2-9 HPV types) was identified in 43 of 82 (52.4%) samples, including 7 of 38 (18.4%) cervical samples, and 36 of 44 (81.8%) anal samples. The prevalence of high-risk HPV, as determined by the PapilloCheck® assay, was 17.6% (36/205) in samples with normal cytology, 83.9% (26/31) in samples with low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance, and 100% (4/4) in samples with high-grade squamous intraepithelial lesions. The results obtained indicate that the PapilloCheck® assay may be considered as a reliable screening test for HPV detection and typing.