Profile of the BD HPV OnclarityTM assay

ABSTRACT

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.

KEYWORDS:

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

ARTICLE HIGHLIGHTS

• A cervical lesion is the product of persistent infection of a high-risk HPV.

• HPV genotyping is helpful for risk stratification and follow-up of the persistence of the same HPV genotype (to discriminate between transient and persistent infections)

Onclarity fulfills international clinical validation criteria for primary screening of cervical cancer1

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewers Disclosure

A reviewer on this manuscript has disclosed that they are involved in HPV test validation according to an international validation protocol (Valgent). Another author has disclosed that they are a senior scientist in Atila Biosystems Inc, which also manufactures and markets its HPV assays worldwide. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This paper was not funded