Comparison of AMPLICOR® and Hybrid Capture II® assays for high risk HPV detection in normal and abnormal liquid-based cytology: Use of INNO-LiPA Genotyping assay to screen the discordant results

Abstract: The study was aimed to evaluate the feasibility of detecting human papillomavirus (HPV) in women with normal or abnormal cervical smears using the Roche Amplicor MWP HPV Test. We compared by AMPLICOR® Test and Hybrid Capture II® (HCII®) Test, the prevalence of HR-HPV in 470 cervical samples including 55 samples with WNL cytology, 208 ASC-US, 193 LGSIL and 14 HGSIL. Samples with discordant results were retested with INNO-LiPA Genotyping HPV Test v2. The HR-HPV positivity in WNL cytology samples was similar (21.8%) by AMPLICOR® and HCII®. In ASC-US, the HPV positivity was 42.3% by both tests. In LGSIL, HPV positivity was 66.3% and 66.8% by AMPLICOR® and HCII®, respectively. In HGSIL, 92.8% of samples were positive by AMPLICOR® and 85.7% by HCII®. The agreement of both tests was 96.2% with a Kappa value of 0.92. Eighteen cases were discordant: 9 HCII® positive/AMPLICOR® negative and 9 HCII® negative/AMPLICOR® positive. The INNO-LiPA test revealed HPV positivity in every case. Interestingly, all HCII®+/AMPLICOR®− samples were found to harbour HPV53. As for the HCII®−/AMPLICOR®+ samples, 8 demonstrated a multiple infection with HR 16- and/or 18- and/or 56-phylogenetically related HPV types. Moreover, two of these samples were co-infected with HPV6 and two other with HPV54. By using consensus HR-HPV as our reference HPV positivity, the sensitivity (96.6%) and specificity (100%) of AMPLICOR® was similar to that of HCII® Test. The AMPLICOR® HPV Test is sensitive, specific, feasible and appropriate for routine HPV detection. [Copyright &y& Elsevier]