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Type‐specific reproducibility of the Roche Linear Array HPV Genotyping Test
Author(s) -
Steinau Martin,
Swan David C,
Unger Elizabeth R
Publication year - 2008
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.22.1_supplement.898.9
Subject(s) - concordance , kappa , reproducibility , genotyping , medicine , human papillomavirus , oncology , genotype , biology , statistics , genetics , mathematics , geometry , gene
Type‐specific detection of Human Papillomavirus (HPV) is increasingly important. 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 not been emphasized, nor has the degree of intra‐assay reproducibility been addressed. The objective was to assess the general and type specific reproducibility of the Linear Array HPV Genotyping Test (Roche Molecular Diagnostics, Alameda, CA). Extracts of 276 cervical samples from two ongoing epidemiologic HPV studies were retested while blinded to prior results. The testing involved 5 different reagent lots and three technologists. 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. Reliability of this HPV test is important as type‐specific assays are considered for clinical management and post‐vaccination surveillance.