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The cobas® HPV Test

Intended use

Per the CE-IVD package insert information, the cobas® HPV Test may be used in ASC-US and adjunctively with cervical cytology as follows:1 

The cobas® 4800 Human Papillomavirus (HPV) Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. 

  • To screen patients with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy.
  •  In women 30 years and older, the cobas® HPV Test can be used with cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the clinicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
  • In women 30 years or older, the cobas® HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the clinician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
  • The cobas® HPV Test is indicated for use in patients with ASC-US cervical cytology results, to assess the presence or absence of
  • high-risk HPV types 16 and 18. This information, together with the clinician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy.
 

This information, together with the clinician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.

Find a lab near you that offers the cobas® HPV Test.

  • Acronyms:

References:

1.cobas® 4800 HPV Test CE package insert. Rev. 9.0