HPV Testing by cobas HPV Test in a Population from Catalonia

Abstract

BackgroundHPV testing in cervical cancer screening has been proposed as an alternative or complementary to cytology in women older than 30 years. However, adequate clinical sensitivity and specificity are crucial for a new test to be implemented. Hybrid Capture 2 (HC2) has proved good clinical performance in selecting women at risk for high-grade intraepithelial lesions with a high sensitivity and specificity. cobas HPV Test has been recently launched and its performance in different clinical settings needs to be determined.ObjectivesThe aim of this study was to evaluate the cobas HPV Test for the detection of cervical HPV infection in a population of women in Catalonia (Spain) using HC2 as a reference.Materials and MethodsCervical liquid cytology samples from 958 women have been studied. Sensitivity was analyzed in 60 samples from patients with a high-grade intraepithelial lesion (≥CIN2) on histology and specificity was determined in 898 samples from women with no ≥CIN2. All cases had HC2 and cobas HPV Test performed. Statistical analyses of sensitivity, specificity and comparison between HC2 and cobas HPV Test by a non-inferiority test were applied.ResultsSensitivity of HC2 and cobas HPV Test for detecting ≥CIN2 proved identical (98.3%) while specificity was 85.3% and 86.2% respectively. The non-inferiority test demonstrated that cobas HPV Test surpassed 90% sensitivity and 98% specificity of HC2.ConclusionThe cobas HPV Test results fulfilled sensitivity and specificity requirements for HPV based cervical cancer screening and for the triage of minor cytological abnormalities, allowing its introduction in clinical settings.

Clinical Validation of AdvanSure GenoBlot Assay as Primary Screening and Test of Cure for Human Papillomavirus Infection

“…The overall positive rates and the concordance rate of the two assays were comparable to those of previous reports [4][5][6][7][8][9][10][11]. The positive rates of individual genotypes were relatively higher in GenoBlot than in HPVDNAChip, with exceptions for genotypes 51 and 56, for which HPVDNAChip showed higher positive rates than GenoBlot.…”

“…In current practice, there are three major contexts in which tests for high risk (HR) genotypes of HPV are relevant: 1) primary screening of cervical cancer and precancerous lesions; 2) triage of low-grade disease; and 3) test of cure after treatment [2,3]. A significant number of studies have been reported for the primary cervical high risk lesion screen and triage; however, little has been reported in terms of the evaluation of test of cure [2][3][4][5][6][7][8][9][10][11].…”

High‐risk HPV platforms and test of cure: should specific HPV platforms more suited to screening in a ‘test of cure’ scenario be recommended?

“…Based on much of the current evidence, the performance of the cobas 4800 and HC2 hrHPV tests should be similar in clinical practice. Studies have demonstrated that the cobas 4800 has a performance (including sensitivity, specificity, and positive and negative predictive values) which is comparable to HC2 for the detection of CIN2 or worse and CIN3 or worse . The Horizon study, however, which compared the two assays in a primary screening population in Copenhagen, found high rates of positive hrHPV with cobas 4800 when compared with HC2 .…”

Quality Control of HPV Test

“…The HPV test shows high sensitivity for CIN2+ and is therefore a useful tool for cervical cancer screening. The Cobas 4800 system is an FDA approved HPV test that has been validated with established criteria [1][2][3]. The Cobas 4800 involves real-time PCR for the detection of high-risk HPV and also informs about HPV 16, HPV 18 and highrisk HPV other than 16 and 18.…”