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Indications and Warnings

Indications:

The Cervista® HPV 16/18 test is indicated:

  1. In women 30 years and older the Cervista HPV 16/18 test can be used adjunctively with the Cervista HPV HR test in combination with cervical cytology to assess the presence or absence of high-risk HPV types 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.
  2. To be used adjunctively with the Cervista HPV HR test in patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, to assess the presence or absence of high-risk HPV types 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.

Warnings:

  • This test is not intended for use in determining the need for treatment (i.e.excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV 16/18 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.
  • The Cervista HPV 16/18 test is not intended for use as a stand-alone assay. Results should be interpreted in conjunction with the Cervista HPV HR and cervical cytology test results.
  • The Cervista HPV 16/18 test is not intended for use in women under age 30 with normal cervical cytology.
  • The Cervista HPV 16/18 test is not intended to substitute for regular cervical cytology screening.
  • 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 16/18 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 16/18 test results should not be used as the sole basis for clinical assessment and treatment of patients.