Profile of the BD HPV OnclarityTM assay

Research output: Contribution to journalArticlepeer-review


Introduction: Validated molecular assays for the detection of high risk (hr) Human Papillomavirus (HPV) DNA underpin the screening protocols against cervical cancer. New molecular assays based on real-time PCR also display the genotype of hrHPV. Areas covered: Recently, the BD Onclarity™ HPV assay (Onclarity), extended HPV genotyping test, for use on the BD Viper™ LT Instrument, has been developed. Onclaritys application for the detection and genotyping of hrHPV has been validated for the identification of women at high risk for cervical intraepithelial neoplasia of grade 2 or more in accordance with European Guidelines and FDA specifications. Expert opinion: Onclarity displays good sensitivity and specificity performance for HR-HPV detection and offers the possibility for genotype-specific reporting: the latter could provide risk-stratification for high-grade cervical disease during screening and facilitate surveillance for persistent genotypes in women at follow-up visits.

Original languageEnglish
Pages (from-to)565-570
Number of pages6
JournalExpert Review of Molecular Diagnostics
Issue number7
Publication statusPublished - Jul 3 2019


  • CIN
  • genotyping
  • HPV
  • Onclarity HPV assay
  • real time PCR

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Medicine
  • Molecular Biology
  • Genetics


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