Comparison of Abbott RealTi m e High Risk HPV and Hybrid Capture 2 for the detection of high-risk HPV DNA in a referral population setting

Abstract Background The Abbott RealTi m e High Risk HPV assay (ART) is an automated multiplex real-time PCR test for detection of DNA from 14 high risk (HR) HPV types in cervical specimens and simultaneous distinction of HPV16 and HPV18 from other HR-HPV. Objectives To evaluate the performance of th...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical virology 2011, Vol.53 (2), p.121-124
Main Authors: Venturoli, Simona, Leo, Elisa, Nocera, Martina, Barbieri, Daniela, Cricca, Monica, Costa, Silvano, Santini, Donatella, Zerbini, Marialuisa
Format: Article
Language:English
Subjects:
Allergy and Immunology
Infectious Disease
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Background The Abbott RealTi m e High Risk HPV assay (ART) is an automated multiplex real-time PCR test for detection of DNA from 14 high risk (HR) HPV types in cervical specimens and simultaneous distinction of HPV16 and HPV18 from other HR-HPV. Objectives To evaluate the performance of the ART assay in specimens referred for HPV testing to our laboratory (referral population) by comparison with historical data from HC2 and INNO-LiPA as well as histological status, if available. Study design 412 cervical specimens were collected from women between 18 and 70 years of age: 301 previously tested by HC2 without clinical data and 111 previously tested by HC2 and INNO-LiPA with histological diagnosis of CIN3+. Results Our study demonstrated good overall agreement between ART, HC2 and INNO-LiPA. In the group of the CIN3+ specimens HR-HPV was detected by ART in 93.07% (95% CI: 88.12–98.02), while HR-HPV detection rates with HC2 and INNO-LiPA were 91.09% (95% CI: 85.53–96.65) and 95.05% (95% CI: 90.82–99.28), respectively. The typing capability of ART for HPV16, HPV18 and a pool of twelve other HR-HPV types was investigated by comparison with INNO-LiPA demonstrating high overall assay concordance (89.81%; k 0.87). Conclusions The Abbott RealTi m e assay showed similar clinical performance for detection of CIN3+ compared with HC2. The high level of automation and ability to identify HPV16, HPV18 and other HR-HPV make this assay a very attractive option for HR-HPV testing, potentially improving patient management by risk stratification of cytological abnormal populations.
ISSN:1386-6532
1873-5967
DOI:10.1016/j.jcv.2011.10.016