To compare the performance of Seegene Anyplex II HPV28 and Seegene Anyplex II HPVHR with EUROIMMUN EUROArray HPV (EuroArray), Roche Cobas® 4800 HPV assay (Cobas), Digene Hybrid Capture (HC) 2, Roche Linear Array (LA) and Roche Amplicor (AMP) for detection of high-risk HPV (HR-HPV) genotypes in women with high grade cervical cytology.
The Seegene HPV28 and HPVHR assays are multiplexed quantitative PCR melting-curve assas used for detection of 28 and 14 HPV genotypes, respectively, including 14 low-risk and 14 high-risk types. Seegene HPV28 is intended as a genotyping product for purposes of triage and patient follow-up tests, while Seegene HPVHR is intended as a primary cervical screening test. PreservCyt® specimens from women undergoing management of high-grade cytological abnormality were evaluated by these 2 assays. Concordance of detection of HR-HPV was calculated compared to previously tested EuroArray, Cobas, HC2, Amp, and LA HPV test results.
Overall specimens were evaluated from 404 women with average age of 30 years. Specimens evaluated included 337 from women with >CIN2 and 67 from women with <CIN1 histological diagnosis. The concordance of HR-HPV detection with Seegene HPV28 compared to other HPV assays was 94.8% (κ=0.844) and 97.27% (κ=0.911) for EuroArray and LA; and with Seegene HPVHR 86.9.6% (κ=0.640), 96.53% (κ=0.888) and 96.8% (κ=0.892) for HC2, Cobas and Amp, respectively. Using HR-HPV detection for prediction of >CIN2 by Seegene HPV28 and HPVHR, sensitivity (90.18, 95%CI 86.48-93.14; 90.77, 95%CI 87.16-93.65) and specificity (67.16, 95%CI 54.60-78.15; 67.65, 95%CI 55.21-78.49) were not significantly different to the other HPV assays. Both assays had higher sensitivity for detection of ≥CIN2 than HC, and specificity of 94% (Seegene HPV28) and 95% (Seegene HPVHR) of HC in this high-risk population. Type-specific comparison between Seegene HPV28 and two full genotyping assays, EuroArray and LA, showed strong to perfect agreement (κ≥0.800) for most common genotypes.
The performance of Seegene HPV28 and HPVHR genotyping assays was highly concordant to other commercial HPV assays evaluated including EuroArray, HC2, Cobas, Amp and LA tests for detection of HR-HPV and prediction of ≥CIN2 in a high prevalence population. For full genotyping, Seegene performed well compared with LA and EuroArray, with some inter-assay variability, as would be expected.