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Why would a woman not want the best test available? Studies show that the Pap is only 50 to 80 percent accurate in identifying women with cervical disease or cancer. With an HPV test, if she has a negative HPV test and a normal Pap, she can be almost 100 percent sure she doesn't have high-grade [advanced] cervical disease or cervical cancer. It just makes sense that HPV testing should be part of cervical cancer screening for women age 30 and older. If a woman's doctor isn't offering it, she should ask why.

Bradley J. Monk, MD Associate Professor, Gynecologic Oncology, University of California-Irvine

HPV Test vs the Pap FAQs - Over 30

Q

You've probably been getting a Pap test for years . . . but do you know why?

A

To do the Pap test, your doctor or nurse scrapes a small sample of cells from your cervix and sends it to a laboratory. A technologist then looks at the cells under a microscope for signs of abnormal changes. The Pap test was developed in 1943 by Dr. George Papanicolaou. Thanks to its regular use since then, many women who need treatment are identified early, causing cervical cancer to drop from the second-leading cause of cancer deaths among American women to the 15th. However, it hasn't eliminated cervical cancer. In fact, more than 11,000 American women still get cervical cancer every year. In this section, you'll learn why.



Q

What are the possible results from a Pap test?

A

When your doctor's office informs you of the result of your Pap, you will likely be told your Pap was normal, abnormal or "borderline" (often called an ASC-US Pap):

Pap Test ResultWhat It Means
Normal Your cervical cells appear to be healthy.
Abnormal* There appear to be changes in your cervical cells that are not normal and need to be examined further.
Borderline or inconclusive (officially called "ASC-US," which stands for atypical squamous cells of undetermined significance) Your cervical cells are not obviously normal, but they are not clearly abnormal either.

* Note that when the lab reports the results of a Pap as abnormal, it may use the terms LSIL or HSIL. LSIL (low-grade squamous intraepithelial lesion) is the term for abnormal cell changes that are mild and likely to go away on their own, without treatment. HSIL (high-grade squamous intraepithelial lesions) refers to cell changes that are moderate or severe and should be removed.



Q

How accurate is the Pap test?

A

The Pap test can identify many women in need of treatment, especially when it is repeated regularly. However, the Pap is not foolproof. One recent study published in the Journal of the National Cancer Institute found that about one third of cervical cancers occur due to Pap failure. In other words, these women's Pap results appeared normal, despite the slowly developing abnormal cells on their cervix. Even with the newer, "liquid-based" Pap abnormal cells may be missed. [For more information on this study, refer to "Cervical Cancer in Women with Comprehensive Health Care Access: Attributable Factors in the Screening Process," by Wendy A. Leyden et al: Journal of the National Cancer Institute; Vol. 97, No. 9; May 4, 2005; pgs. 675-683.]

As a result, "false negative" results are possible from a Pap test. This means you are told your Pap is normal, when abnormal cells that could cause problems actually exist.

For example, a false negative Pap may occur when the sample being examined does not contain enough cervical cells. Abnormal cells also may be hard to see if they are "hidden" by mucous or inflammation in the cervix. Or, signs of abnormal cells may simply be missed by the laboratory technologist when looking through the microscope.

A recent study in the Journal of the National Cancer Institute found that the Pap is particularly less accurate in detecting abnormal cells associated with a type of cervical cancer called "adenocarcinoma," which has become more common in recent years. The authors concluded that the use of routine HPV testing has the potential to reduce the occurrence of this type of cancer.

[For more information on this study, refer to "Worldwide Human Papillomavirus Etiology of Cervical Adenocarcinoma and Its Cofactors: Implications for Screening and Prevention," by Xavier Castellsague et al: Journal of the National Cancer Institute; Vol. 98, No. 5; March 1, 2006; pgs. 303-315.]

Pap tests also may be "false positive." This means a woman is told that her cervical cells look abnormal when they are actually healthy. This can cause anxiety and lead to unnecessary tests and procedures.



Q

What is the HPV test?

A

QIAGEN developed the first FDA-approved test to detect the presence of high-risk (cancer-causing) types of HPV. The digene HPV Test, which uses the company’s proprietary Hybrid Capture® 2 (hc2) technology, was approved by the U.S. Food and Drug Administration (FDA) in 1999 for follow-up evaluation of women whose Pap results are inconclusive ("ASC-US"), allowing healthcare providers to determine whether they need further examination. In 2003, the digene HPV Test was approved for routine use along with a Pap for all women 30 years of age and older, the group considered most at risk of cervical cancer. 

Click here (PDF) for full medical and technical information on the digene HPV Test.

The ability to identify women at risk has repeatedly been shown to be greater when the HPV test is done along with the Pap than when the Pap smear is used alone. On average, studies show that the combination of the digene HPV Test and the Pap identifies 95-100 percent of advanced cervical disease (CIN 2, CIN 3 or cancer).



Q

How is the digene HPV Test done? Does it require any additional procedures?

A

The digene HPV Test can be done by any laboratory, usually using the same sample of cervical cells collected for the Pap. It does not require any additional time or discomfort on your part.



Q

Who should get the digene HPV Test?

A

All women over the age of 30 can benefit from getting the HPV Test along with their Pap, regardless of their Pap results.



Q

Do you need to ask your doctor or nurse for the HPV test, or will it be given automatically?

A

Most doctors and nurses routinely order an HPV test for women with inconclusive Pap results. However, this is not yet true for the routine screening of women over 30 (which means you should get the HPV test regardless of your Pap result). Thus, it's a good idea to call before your appointment (or when choosing a healthcare provider) to request it. Click here to learn more about why your doctor or nurse may not yet be routinely offering the HPV test.



Q

What are the possible results of the digene HPV Test?

A

The digene HPV Test will either tell you that you have one or more high-risk types of HPV, or that you don't.

If the test shows you have high-risk HPV, but your Pap is normal, experts recommend that you be re-tested in a year to determine if the infection is persisting (since only longer-lasting infections can cause abnormal cells to form). However, if you have high-risk HPV and your Pap is abnormal or inconclusive, experts recommend that you immediately have an additional examination (colposcopy) to determine if abnormal cells are present that need to be removed.

If, on the other hand, testing shows you do not have high-risk HPV, your risk of having cervical disease is very small – particularly if your Pap is normal as well. Read more about understanding the possible HPV and Pap test results.



Q

Can the digene HPV Test tell what type of HPV you have?

A

The digene HPV Test, the first FDA-approved HPV test, tells you and your healthcare provider whether you have one or more high-risk types of the virus. However, although the test does not tell you which of those types you have, the extra exams and other follow-up care you should get if you have a form of high-risk HPV is currently the same no matter what strain you have.

Here’s a little background: There are about 15 types of high-risk HPV that can cause cervical cancer. Of those, 13 are considered the most important, and are known by the numbers assigned to them (in the order of their discovery): 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. [There are more than 100 different types of HPV all together.]

Of these 13 types of high-risk HPV, two of them – 16 and 18 – have been shown to cause 70 percent of all cervical cancers. As a result, QIAGEN and other companies are developing additional tests that can determine which specific type(s) of HPV are present.



Q

How accurate is the digene HPV Test?

A

Although no test is perfect, the digene HPV Test is less vulnerable to error than the Pap. Studies show that, on average, the combination of the digene HPV Test and the Pap identifies 95-100 percent of women who are later confirmed to have advanced cervical disease (CIN 2, CIN 3 or cancer).



Q

How accepted is the digene HPV Test for cervical cancer screening?

A

The American College of Obstetricians and Gynecologists (ACOG), the American Cancer Society (ACS) and the American Society for Colposcopy and Cervical Pathology (ASCCP)all have recognized the advantages of HPV testing for cervical cancer prevention, and the use of HPV testing for older women (age 30+) is increasing gradually.

However, since it can take a while for healthcare professionals to make changes in the way they practice medicine, women 30 and older often need to ask their doctors or nurses to order the HPV test along with their Pap.



Q

Why are both the HPV test and Pap necessary? Why not just test for HPV?

A

The digene HPV Test and the Pap look for different "clues":

Getting both the digene HPV Test and a Pap offers the most peace of mind for women 30 and older -- the age group that is most at risk of cervical cancer. If you do not have HPV and your Pap is normal, you can be confident you do not have abnormal cells that could develop into cervical cancer without being detected. If you do have HPV, and/or have an abnormal Pap, you and your healthcare provider now know that additional procedures are needed to determine if you have abnormal cells that need to be treated.

Looks ForHow it Works
Pap test Signs of abnormal cell changes Lab professional looks at a sample of cervical cells through a microscope
digene HPV Test The virus that causes the abnormal cell changes that can lead to cervical cancer A test is done on the sample of cervical cells by a computerized system