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.
- A subgroup of the human papillomaviruses (HPVs) are known to cause cancers of the uterine cervix and other genital areas, the so-called "high risk" HPVs.
- The Cervista test is used to diagnose the presence of DNA from the "high-risk" HPVs in cervical samples.
- 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.
- 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.
- The sample for the test is taken in the same way that a Pap smear test is performed.
- Cervista testing is not recommended for routine screening; rather, it is used in combination with physical examination, medical history, and other testing to help make decisions about management and follow-up on a case-by-case basis.
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.
What is human papillomavirus (HPV)?
- Of the more than 100 types of papillomaviruses (HPVs) that infect humans, more than 40 types can infect the anogenital tract (genital tract and anus) of men and women and cause genital warts (known as condylomata acuminata or venereal warts).
- A subgroup of the HPVs that infect the anogenital tract can lead to precancerous changes in the uterine cervix and cause cervical cancer or other genital cancers in women.
- The HPV types that cause cervical cancer also have been linked with both anal and penile cancer in men.
- The most common HPV types that infect the anogenital tract are HPV types 6, 11, 16, and 18 (HPV-6, HPV-11, HPV-16, and HPV-18), although other HPV types can also infect the anogenital tract.
- Among these, HPV-6 and HPV-11 are most commonly associated with benign lesions such as genital warts and mild dysplasia of the cervix (potentially precancerous changes in the appearance of cervical cells under a microscope) and are termed "low-risk" HPV types.
- In contrast, HPV-16 and HPV-18 are the types found in the majority of cervical and anogenital cancers as well as severe dysplasia of the cervix.
- These belong to the so-called "high-risk" group of HPVs. Twelve other HPV types have also been identified as causes of cervical and other genital cancers, although these are less common than HPV-16 and -18.
- HPV infections are transmitted primarily by sexual intimacy, and the risk of infection increases as the number of sexual partners increase.
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."
What do the results of an HPV test mean?
- A positive test result does not mean that a woman will definitely get cervical cancer.
- The results of the test are used to help estimate a woman's risk of developing cervical cancer or to estimate the severity or risk of findings that may not be clear from physical examination and Pap screening.
- As discussed previously, the results of the Cervista HPV test are not interpreted alone but in combination with Pap testing, medical history, and physical examination.
- The test gives one more piece of information to help the health care practitioner make the best decisions about further monitoring and management for each woman on a case-by-case basis.
FDA.gov. FDA Approved First DNA Test for Two Types of Human Papillomavirus. News release, March 13, 2009.
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