Indications and Warnings

Indications:

To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
In women 30 years and older the Cervista^® HPV HR 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.

Warnings:

The Cervista HPV HR test is not intended for use as a screening device for women under age 30 with normal cervical cytology.
The Cervista HPV HR test is not intended to substitute for regular cervical cytology screening.
Detection of HPV using the Cervista HPV HR test does not differentiate HPV types and cannot evaluate persistence of any one type.
The use of this test has not been evaluated for the management of women with prior cytological or histological abnormalities, hysterectomy, who are pregnant, postmenopausal, or who have other risk factors (e.g. HIV+, immunocompromised, history of STI).

The Cervista HPV HR test is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.

Cervista HPV HR test results should not be used as the sole basis for clinical assessment and treatment of patients.