For in vitro diagnostic use. Others cobas HPV Test 5800-6800-8800 IVD cobas® HPV PID00000297 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems 09 040 544 190 9 040 544 190 09040544190 9040544190 09040544190 KIT COBAS 58/68/8800 HPV 480T IVD cobas HPV 00875197006889 Reagents, kits 1 kit 480 tests true 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: 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. 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. cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HR HPV types. cobas® HPV is indicated for use adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18. 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. 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 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. en 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: 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. 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. 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. 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. 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. 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 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. en cobas® HPV for use on the cobas® 5800/6800/8800 Systems (cobas® HPV) is a qualitative in vitro test for the detection of high-risk Human Papillomavirus. This test detects the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in the specimens listed below. Clinician-collected cervical specimens should be obtained using an endocervical brush/spatula or broom and placed in the ThinPrep® Pap Test™ PreservCyt® Solution. Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical samples otherwise cannot be obtained. cobas® HPV is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of individuals with a cervix to assess the risk for cervical precancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors. CONTRAINDICATIONS: None en

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