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

Autor: Donatella Santini, Daniela Barbieri, Marialuisa Zerbini, M. Nocera, Elisa Leo, Simona Venturoli, Silvano Costa, Monica Cricca
Přispěvatelé: S. Venturoli, E. Leo, M. Nocera, D. Barbieri, M. Cricca, S. Costa, D. Santini, M. Zerbini
Rok vydání: 2012
Předmět:
Adult
Risk
medicine.medical_specialty
Adolescent
Referral
Concordance
Population
REFERRAL POPULATION
Uterine Cervical Neoplasms
Cervix Uteri
REAL TIME PCR
Real-Time Polymerase Chain Reaction
Cervical intraepithelial neoplasia
Young Adult
HPV TESTING
Virology
Internal medicine
medicine
Humans
Multiplex
Typing
education
Referral and Consultation
Aged
Gynecology
Human papillomavirus 16
education.field_of_study
Human papillomavirus 18
business.industry
CERVICAL CANCER SCREENING
Papillomavirus Infections
Reproducibility of Results
Middle Aged
Uterine Cervical Dysplasia
medicine.disease
female genital diseases and pregnancy complications
Infectious Diseases
Real-time polymerase chain reaction
Molecular Diagnostic Techniques
HPV16/18 TYPING
High risk hpv
DNA
Viral
Female
Reagent Kits
Diagnostic
business
Zdroj: Journal of Clinical Virology. 53:121-124
ISSN: 1386-6532
DOI: 10.1016/j.jcv.2011.10.016
Popis: 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.
Databáze: OpenAIRE
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