Human papillomavirus (HPV) testing is routinely used within the National Health Service cervical screening programme (NHSCSP) to triage women with low-grade cytological abnormalities for appropriate referral for colposcopy. The NHSCSP also uses HPV testing for women who have been previously treated for cervical disease known as the 'test of cure' (ToC) and if their negative/low-grade cytology test is HPV negative they are returned to routine surveillance. As new technologies for HPV testing have become available, they have been validated against the Qiagen HC2 assay for approval within the NHSCSP. Thereafter, NHSCSP approved assays can be used for validation of any new assays for introduction within the NHSCSP and a number of these approved tests also offer genotyping at a minimum for high risk HPV types 16, 18 and others. The Roche cobas HPV test uses the polymerase chain reaction (PCR) and real time PCR amplification to detect HPV 16, 18 and 12 other HPV types (31, 33, 35, 39, 45, 51 52, 56, 58, 59, 66 and 68). The BD Onclarity HPV test is a real time PCR assay too which identifies HPV 16, 18, 45, 31, 51 and 52 individually and groups the other HPV types into three groups (33,58), (56,59,66) and (35,39,68). Here, we compare the performance of the BD Onclarity HPV assay to the Roche cobas 4800 HPV test for overall HPV positivity and for genotyping of HPV 16, 18 and others.
Cervical samples from women with low-grade cytology and ToC were HPV tested with the BD Onclarity HPV test on the BD Viper LTand the Roche cobas 4800 platform. The BD Onclarity assay results were compared to the Roche cobas 4800 assay and their relative sensitivity assessed. Any women with positive HPV results from either platform were referred for colposcopic assessment.
To date we have compared the HPV results of 1164 cervical samples with low-grade cytology in the triage arm and 673 in the ToC arm. There was 97% agreement for the two asaays in the triage arm and 91.8% in the ToC arm. Both tests so far have detected all CIN2+ cases. Discordant sample results and genotyping comparisons will be presented and discussed.
| cobas POS | Cobas NEG | Grand Total | |
| Triage | 872 (74.9%) | 292 (25.9%) | 1164 |
| Onclarity POS | 842 (72.3%) | 5 (0.4%) | 847 |
| Onclarity NEG | 30 (2.6%) | 287 (24.7%) | 317 |
| ToC | 174 (25.9%) | 499 (74.1%) | 673 |
| Onclarity POS | 124 (18.4%) | 5 (0.7%) | 129 |
| Onclarity NEG | 50 (7.4%) | 494 (73.4%) | 544 |
| Grand Total | 1046 | 791 | 1837 |
With the results collated to date, the BD Onclarity HPV assay performed very similarly to the Roche cobas 4800 assay and there was broad agreement on the genotyping.