Digene HPV Genotyping RH Test RUO: comparative evaluation with INNO-LiPA HPV Genotyping Extra Test for detection of 18 high-risk and probable high-risk human papillomavirus genotypes.

摘要: Background: Standardized and validated methods for the specific detection identification of a spectrum high-risk (hr) HPV genotypes will be necessary if genotyping gains an important role in clinical management HPV-related precancerous lesions cancers. Objectives: The first comparative evaluation novel Digene Genotyping RH Test RUO (Qiagen, Hilden, Germany) with standard INNO-LiPA Extra CE assay (Innogenetics, Gent, Belgium). Study design: Seventy hr-HPV positive samples were tested parallel both assays. results interpreted taking into account 15 3 probable that can identified by assays (assay-common genotypes). Results: Concordant (a complete match assay-common or negative using assays) compatible (at least one genotype common) obtained 42 (60.0%) 28 (40.0%) samples, respectively. No discordant obtained. Of results, presence at was detected 37 while no two only single low-risk three samples. Conclusions: A test is suitable it provides comparable to well established assay. Although significantly more multiple than test, benefit such difference present unclear.