Type-specific reproducibility of the Roche linear array HPV genotyping test.

BACKGROUND: Type-specific detection of human papillomavirus (HPV) is increasingly important for monitoring temporal and age-specific changes in type-specific prevalence in support of HPV vaccination efforts. The impact of sampling, extraction and assay characteristics on HPV results is increasingly recognized. Inter-assay comparability studies have been performed, but the robustness of type-specific results has neither been emphasized nor has the degree of intra-assay reproducibility been addressed.
OBJECTIVES: Here we describe the general and type-specific reproducibility of the linear array HPV genotyping test (Roche Molecular Diagnostics, Indianapolis, IN). STUDY
DESIGN: Extracts of 276 cervical samples from two ongoing epidemiologic HPV studies were retested while blinded to prior results. The testing involved five different reagent lots and three technologists.
RESULTS: Concordance for HPV detection (sample positive versus negative for any of the 37 types) was high (98.2%, kappa=0.959). Type-specific concordance for individual HPV types was also high (99.4%, kappa=0.915), and most samples (83.0%) showed complete concordance for all types.
CONCLUSIONS: Type-specific reproducibility of the linear array HPV genotyping test is good but not perfect. The results suggest that type-specific performance should be included in the evaluation of HPV typing formats.