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What is the Cervista HPV test?
The Cervista HPV test, manufactured by Hologic, is a test that is used to identify the presence of human papillomavirus (HPV) genetic material, or DNA, in cervical samples, such as samples taken during Pap screening or colposcopy. The Cervista test was approved by the U.S. Food and Drug Administration in March of 2009 and was the first DNA test approved by the FDA for detection of HPV in women.
Two different tests are available, known as Cervista HPV 16/18 and Cervista HPV HR. Cervista HPV 16/18 is used to diagnose the presence of DNA from the two most common HPV types associated with cancer, HPV 16 and 18, while Cervista HPV HR is used to diagnose all 14 "high risk" or cancer-associated HPV types. The choice for which test to use depends on what information the patient's physician wants to collect.
How is the HPV test done?
For the Cervista test, a sample is taken from the cervix in the same way that a sample for Pap testing is obtained. It can be performed at the same time as Pap testing or colposcopy. There is no special preparation needed for the test, although women should try to schedule Cervista and other screening tests about two weeks after their last menstrual period and try to avoid having the test performed during the menstrual period. Results are typically ready in about the same time as normal Pap screening results.
Who should be tested for HPV?
The Cervista test is not used for routine screening of all women and is not intended to be a stand-alone test. It is not recommended for testing in women under 30 years of age who have normal cytology (Pap) results. Cervista is designed for use in women age 30 and older or women with unclear or borderline Pap screening results, such as ASC-US (atypical squamous cells of unknown significance) or low grade squamous intraepithelial lesions (LSIL). It can provide more information about the risk of cervical cancer for women who may have precancerous changes of the cervix.
According to the manufacturer, the Cervista test "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."