The cobas^® HPV Test

Intended use

Per the U.S. package insert information, the cobas® HPV Test may be used in ASC-US and adjunctively (co-testing) with Pap as follows:¹

• To screen patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy.
• To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, 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 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 cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physician's assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management.
• In women 30 years and older, the cobas^® HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18.
• In women 25 years and older, the cobas^® HPV Test can be used as a first-line primary cervical cancer screening test to detect high risk HPV, including genotyping for 16 and 18. Women who test negative for high risk HPV types by the cobas^® HPV Test should be followed up in accordance with the physician’s assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV genotypes 16 and/or 18 by the cobas^® HPV Test should be referred to colposcopy. Women who test high risk HPV positive and 16/18 negative by the cobas^® HPV Test (12 other HR HPV positive) should be evaluated by cervical cytology to determine the need for referral to colposcopy.

This information, together with the physician'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.