The cobas® 4800 HPV Test (Roche Molecular Systems, Inc., Branchburg, NJ, USA) is an automated qualitative in vitro test for the detection of 14 high risk HPV genotypes. This system identifies HPV16 and HPV18 genotypes separately, while simultaneously detecting 12 other HRHPV (HPV31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels in cervical samples. In the present study we aimed to correlate the detection of HRHPV by cobas® 4800 with pre malignant cervical lesions.
From January to December 2014, 145 cervical samples from145 women attending the Gynaecology Unit with a result of HSIL lesions in cytology were included in this study. Biopsy data were also analyzed. The presence of HR HPV were investigated by cobas® 4800. The same vial (Thin Prep) was used for cytology and HPV detection
| BIOPSIA | 16 | 18 | HRHPV | 16+HRHPV | 18+HRHPV | 16+18 | 16+18+HRHPV | NEGATIVE | TOTAL |
| NILM | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 2 | 4 |
| CIN1 | 0 | 0 | 4 | 2 | 0 | 0 | 0 | 0 | 6 |
| CIN2 | 3 | 1 | 15 | 8 | 2 | 0 | 0 | 1 | 30 |
| CIN3 | 30 | 3 | 26 | 17 | 2 | 1 | 1 | 2 | 82 |
| CANCER | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 2 |
| METAPLASIA | 1 | 0 | 4 | 4 | 0 | 0 | 0 | 1 | 10 |
| NO BIOPSY | 3 | 0 | 6 | 2 | 0 | 0 | 0 | 0 | 11 |
| TOTAL | 37 | 4 | 58 | 34 | 4 | 1 | 1 | 6 | 145 |
Biopsy data were not available for 11 out of the 145 patients. 10 cervical samples were informed as squamous metaplasia. 4, 6, 30 and 82 cervical samples were reported as NILM, CIN1, CIN2 and CIN3 respectively and 2 invasive cancers were found.
HPV16 and 18 as a unique genotype was present in 37 and 4 samples, respectively. HPV16 and HPV18 together were detected in 1 sample. Mixed infection including HPV16 plus HRHPVnon16,18 and HPV18 plus HRHPVnon16,18 were present in 34 and 4 samples, respectively. HPV16 plus HPV18 plus HRHPV non16,18 in only 1 sample. HRHPV non16,18 were found in 58 samples. 6 samples had negative results for any HRHPV. The histology results of these 6 negative samples were 2 NILM, 1 squamous metaplasia, 1 CIN2 and 2 CIN3.
Cobas 4800 detected the presence of HRHPV in 139 of 145 histologically confirmed HSIL+ samples. HPV16 and/or HPV18 were present and differentiated separately in 81 (58.2%) samples, in 41/81 (50.6%) as a unique genotype. To identify separately HPV16 and HPV18 is important since these women even with normal citology should be referred for colposcopic examination