The new Abbott RealTime HR HPV test (Abbott, Germany) is a qualitative real-time PCR assay that detects 14 HPV (Human Papillomavirus) genotypes and simultaneously identifies women infected with HPV-16 and -18, which are responsible for more than 70% of cervical cancers worldwide.
In the present study, a total of 108 cervical specimens were tested at the Educational Public Health Institute of Split and Dalmatia County. The presence of HPV DNA in clinical samples was established based on the accordance between two assays, the Abbott PCR and Hybrid Capture 2 (HC2) test (Qiagen, Germany). Discrepant samples were further genotyped by using INNO-LiPA HPV Genotyping Extra Test (Innogenetics, Belgium) at the University Hospital for Infectious Diseases "Dr. Fran Mihaljevic", Zagreb.
Based on the results of the Abbot PCR test, HC2 and INNO-LiPA assay, 49 of 108 samples were considered HPV DNA-positive. Therefore, the analytical sensitivity of the Abbott P CR test for the detection of HPV infection was 96% (detected 47 of 49 positive samples) and the analytical sensitivity of the HC2 test was 90% (detected 44 of 49 positive samples).
In this study, the presence of disease (histology result of CIN2 or greater) was detected in 17 of 108 patients. Prevalence of disease was 15.7%. Clinical sensitivity of the Abbott PCR assay for detection of disease was 100% whereas HC2 assay detected 15 of 17 patients with ≥CIN2 (clinical sensitivity of 88.2%).
In conclusion, Abbott PCR test was more accurate at detecting cases of high risk HPV infection and disease than standard HC2 assay. However, clinical significance of additional positive HPV DNA results obtained by Abbott PCR test needs to be confirmed in good long-term clinical follow up of the patients.