The cobas® HPV tests are an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA in patient specimens. The tests utilize amplification of target DNA by the polymerase chain reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk HPV (hrHPV) types in a single analysis.
This solution enables a patient to privately collect a vaginal sample for HPV screening following instructions provided by a healthcare worker. The sample is then resuspended immediately after collection in Roche Cell Collection Medium or PreservCyt® Solution. The vaginal sample is clinically validated for analysis with the Roche cobas® 4800 HPV Test on cobas® 4800 or cobas HPV test on a cobas® 5800/6800/8800 system.
Internal control: The ß-globin internal cellular control helps prevent false negatives. HPV negative specimens with a negative ß-globin result are flagged as invalid, helping to prevent reporting of false negative results
Use of AmpErase Enzyme: Each reaction contains AmpErase Enzyme, reducing the risk of false positive results from carry-over contamination by differentiating amplification products from target molecules
No cross reactivity: Demonstrates no cross-reactivity with non-high risk HPV genotypes, ensuring that positive results are clinically meaningful
HPV primary screening with the cobas® HPV test helps identify women at risk for disease, before pre-cancer or cancer develops.
Assays are validated in clinical performance studies (e.g. cobas® HPV test was validated in the ATHENA Trial)1
Validated for detection of =CIN2 lesions and not simply presence of HPV1
Validated to the standards set forth in international guidelines for HPV testing for cervical screening purposes2,3
cobas® HPV for use on the cobas® 5800/6800/8800 Systems (cobas® HPV) is an automated qualitative in vitro test for the detection of human papillomavirus (HPV) DNA in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies HPV16 and HPV18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels. Specimens are limited to cervical cells collected in Roche Cell Collection Medium (Roche Molecular Systems, Inc.), PreservCyt® Solution (Hologic Corp.) and SurePath™ Preservative Fluid (BD Diagnostics-TriPath).
Indications for use of cobas® HPV are:
A. In women 25 years and older, cobas® HPV is indicated for use in screening patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
B. In women 25 years and older, cobas® HPV is indicated for use in screening patients with ASC-US cervical cytology results to assess the presence or absence of HR HPV genotypes 16 and 18.
C. In women 30 years and older, cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HR HPV types.
D. In women 30 years and older, cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18.
E. In women 25 years and older, cobas® HPV is indicated for use as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or presence of high-grade disease.
F. In women 25 years and older, cobas® HPV is indicated for use as a first-line primary screening test to assess the presence or absence of HPV genotypes 16 and 18.
cobas® HPV and cobas® 4800 HPV Test can also be used with healthcare worker–instructed self-collected vaginal specimens collected in Roche Cell Collection Medium or PreservCyt® Solution
The results from cobas® HPV, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of cobas® HPV are not intended to prevent women from proceeding to colposcopy.