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.