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The cobas® HPV Test

Intended use

Per the CE package insert information, indications for use of the the cobas® 4800 HPV Test are1:

(a) The cobas® 4800 HPV Test is indicated for use in screening patients with ASC-US (atypical squamous cells of undetermined significance) cervical cytology results to determine the need for referral to colposcopy.
(b) The cobas® 4800 HPV Test is indicated for use in screening patients with ASC-US cervical cytology results to assess the presence or absence of high-risk HPV genotypes 16 and 18.
(c) The cobas® 4800 HPV Test is indicated for use adjunctively with cervical cytology to assess the presence or absence of high risk HPV types.
(d) The cobas® 4800 HPV Test is indicated for use adjunctively with cervical cytology to assess the presence or absence of HPV genotypes 16 and 18.
(e) The cobas® 4800 HPV Test 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) The cobas®4800 HPV Test is indicated for use as a first-line primary screening test to assess the presence or absence of HPV genotypes 16 and 18.

The results from the cobas HPV Test, 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 the cobas HPV Test are not intended to prevent women from proceeding to colposcopy.

 

Contact a Roche representative for more information about the  cobas®  HPV Test.

 


  • Acronyms:

References:

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