Commercially available assays for multiplex detection of alpha human papillomaviruses

Abstract

Five main groups of commercial assays for the multiplex detection of alpha human papillomaviruses (HPVs) are currently available. DNA-based screening assays, which test for the presence of 13–14 HPVs without determination of HPV type, have been the standard for HPV detection in the last decade. Assays that combine testing for 14 HPVs and HPV-16 and HPV-18 genotyping are a potential future standard for HPV detection. The clinical value of HPV genotyping assays has still not been finally determined. Recently, one of the mRNA-based assays showed equal clinical sensitivity but higher clinical specificity for CIN2+/CIN3+ in comparison with the validated DNA-based assay. In situ hybridization assays are too laborious and have insufficient clinical sensitivity to be used in routine screening. Automation, price reduction and improvement of clinical specificity are the main goals for the future development of HPV assays.

Keywords::

• cervical cancer
• diagnosis
• HPV
• human papillomaviruses
• PCR

Financial & competing interests disclosure

The institution at which Mario Poljak and Boštjan J Kocjan have undertaken evaluations of various HPV tests has received research funding and/or free-of-charge kits from Abbott, Digene, Innogenetics, Roche and Seegene to support comparative studies of different HPV tests discussed in this article. Mario Poljak has also received travel grants and honoraria from Abbott, Digene, Innogenetics and Roche for speaking and for participation at scientific conferences and sitting on advisory boards. Boštjan J Kocjan has received a consultation fee from Abbott. The authors have no other 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 apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Notes

^†US FDA-approved assays.

HPV: Human papillomavirus; hr: High-risk.