Transition from Hybrid Capture 2 to Cobas 4800 in Hpv detection: sensitivity and specificity for Cin2+ in two time periods.

Background: High-risk (HR) Human Papilloma Virus (HPV) Tests for HPV detection differ in sensitivity and specificity. In this study, we evaluated the sensitivity and specificity of the HC2 HR HPV Test and the Cobas 4800 HPV Test in consecutive cervical samples collected from a referral population with a high prevalence of disease, using CIN2+ histology as clinical outcome.

Methods: Ten thousand two-hundred and thirteen consecutive cervical samples were assayed for HR-HPV in the Laboratory Medicine Division of IEO: 5140 from January 2012 to June 2013 with HC2 and 5073 from July 2013 to December 2014 with the Cobas HPV Test.

HPV self-sampling in CIN2+ detection: sensitivity and specificity of different RLU cut-off of HC2 in specimens from 786 women.

Aims: Mortality for cervical cancer varies between the different regions of the world, with high rates in low-income countries where screening programmes are not present and organised. However, increasing screening coverage is still a priority in all countries: one way to do that is to base screening on self-sampled screening. The success of a self-sampling screening strategy depends on capacity to recruit unscreened women, on the performance and acceptability of the device and on the clinical performance of the high-risk human papillomavirus (HPV) test.

Comparison of Onclarity Human Papillomavirus (HPV) Assay with Hybrid Capture II HPV DNA Assay for Detection of Cervical Intraepithelial Neoplasia Grade 2 and 3 Lesions.

Analytical and clinical performance validation is essential before introduction of a new human papillomavirus (HPV) assay into clinical practice. This study compares the new BD Onclarity HPV assay, which detects E6/E7 DNA from 14 high-risk HPV types, to the Hybrid Capture II (HC2) HPV DNA test, to concurrent cytology and histology results, in order to evaluate its performance in detecting high-grade cervical lesions. A population of 567 women, including 325 with ≥ASCUS (where ASCUS stands for atypical cells of undetermined significance) and any HC2 result and 242 with both negative cytology and negative HC2 results, were prospectively enrolled for the study.