Performance evaluation of Anyplex™II HPV28 detection kit in a routine diagnostic setting: Comparison with the HPV Sign® Genotyping Test

Fabbio Marcuccilli, Francesca Farchi, Walter Mirandola, Massimo Ciccozzi, Pierpaolo Paba, Elena Bonanno, Carlo Federico Perno, Marco Ciotti

Research output: Contribution to journalArticle

Abstract

Anyplex™II HPV28 is a new PCR assay designed for HPV genotyping. It can detect 28 HPV types including 19 high-risk and 9 low-risk types.This study evaluated the performance of Anyplex™II HPV28 on 123 fresh cervical samples screened in parallel with HPV Sign® Genotyping Test. Of the 123 samples screened, 93 were positive, 15 negative, and 15 discordant. The total number of HPV positive samples combined was 108: 38 single infections and 70 multiple infections. The agreement between the two tests was 87.8%, κ=. 0.592. Genotype specific agreement was strong for HPV 16 (. k=. 0.761), HPV 18 (. k=. 0.674), and HPV 35 (. k=. 0.796). Sensitivity and specificity of Anyplex™II HPV28 assay using HPV Sign® Genotyping Test as reference was 84.8% and 94%; conversely, sensitivity and specificity of HPV Sign® Genotyping Test was 29% and 99.5%. Anyplex™II HPV28 assay is a sensitive and specific assay suitable for HPV genotyping but requires clinical validation.

Original languageEnglish
Pages (from-to)8-13
Number of pages6
JournalJournal of Virological Methods
Volume217
DOIs
Publication statusPublished - Jun 1 2015

Keywords

  • HPV
  • HPV molecular diagnosis
  • Multiplex real-time PCR

ASJC Scopus subject areas

  • Virology
  • Medicine(all)

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