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What to know about new self-collection HPV screening tests

The FDA has approved self-collection for HPV testing in a clinical setting.
The FDA now allows women to privately collect the sample for HPV themselves in the doctor’s office.

In the 1970s and 1980s, scientists established a link between cervical cancer and human papillomavirus (HPV), an extremely common virus in men and women. Around 2000, physicians started screening certain women for the virus as part of their regular gynecological care and eventually recommendations made the swab test a routine preventative test either by itself or as part of a pelvic exam or pap test.

In May 2024, another leap forward in cervical cancer prevention occurred when the U.S. Food and Drug Administration (FDA) approved an HPV self-collection test for women, which may eliminate the need for a pelvic exam to collect cell samples. Clinical trials are also underway to develop an at-home test that would streamline the HPV screening process even more.

“A pelvic exam is not something that a lot of women find to be comfortable,” says Nnamdi Gwacham, D.O., a gynecologic oncologist with City of Hope® Cancer Center Phoenix. “Because of that discomfort, women may not get screening tests for cervical cancer, and ultimately end up with locally advanced and, in some cases, metastatic cervical cancer.”

With more accessible HPV testing and an HPV vaccine available, Dr. Gwacham hopes that the United States will one day be like Australia, the Netherlands and several other countries where cervical cancer has all but been eradicated.

“Australia’s rates of cervical cancer are almost nonexistent, and that's due to a combined effort that the country has undertaken to ensure that every child is vaccinated very early and women get proper screening,” he says.

In this article, we’ll explore:

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What is an HPV test?

An HPV test is performed using a swab to take a sample of cells from a woman’s cervix. The sample is sent to a laboratory to determine if HPV cells are present. If the result is positive, more tests may be performed.

“An HPV test really informs us about the presence of viral changes related to HPV in the cervix,” says Dr. Gwacham. “The important thing that we need to know about HPV is it’s the one that has been linked to probably 89 to 90 percent of the typical cervical cancers we see. So, that is why it's important to evaluate for the presence of HPV — because we are able to identify early changes in the cervix that allow us to intervene before the carcinogenesis process is complete, ultimately ending up with a malignancy in the cervix. That's why screening is so important.”

The FDA’s approval of the HPV self-collection test in May 2024 allows women to collect the sample themselves in the doctor’s office, giving the patient some privacy. The patient inserts the swab into her vagina to collect cervical cells.

“For patients who don't want to have a pelvic exam, patients that may have had some form of sexual trauma, for instance, may be best for self-collection in the office,” Dr. Gwacham says. “Performing the test under a clinician’s supervision helps ensure that the swab is performed properly so that we can actually obtain the information that we need.”

In January 2025, the National Cancer Institute announced the launch of trials to test the efficacy of at-home HPV self-collection kits. Twenty-five sites throughout the country are enrolling women to participate in what the NCI’s Division of Cancer Prevention (DCP) is calling the Self-collection for HPV testing to Improve Cervical Cancer Prevention (SHIP) Trial Network.

“The SHIP Trial Clinical Enrollment Sites cover a wide spectrum of health system settings and have the potential to enroll geographically, socioeconomically, racially and ethnically diverse participants. Demonstrating that underserved populations are willing to participate in self-collection-based cervical cancer screening could help us reach those populations with the greatest need,” said DCP Director Philip Castle, Ph.D., M.P.H.

The trial will involve patients in performing an HPV self-collection swab in a simulated home-like setting within a clinic. This sample will then be compared to one collected by the doctor at the same visit. The study will compare the test results as well as get the patients’ input on the ease of the self-collection system and whether they would prefer that method in the future.

Pap smear versus HPV test

To the doctor or the lab examining the cells collected, an HPV test and pap smear are two separate and distinct tests, but to a patient, the procedures may seem indistinguishable.

A pap — short for Papanicolaou — test, also known as a pap smear, is a pelvic exam in which the doctor uses a speculum to widen the vagina to visually assess the health of the cervix and to collect cells using a swab, like in an HPV test. This sample, however, is examined under a microscope to see if any precancerous or cancerous cells are present.

An HPV test is often performed at the same time using a swab, but the sample is used to determine if the virus is present.

“I think that patients may not know what is being done to them,” says Dr. Gwacham. “There's a swab and there's a pelvic exam involved. So, I think that historically speaking, all women just say, ‘I'm just having a pap.’ However, their provider may be doing the co-test [a swab for HPV and for cells on the cervix] or just a primary HPV screen [a swab for the presence of the virus].”

Who’s eligible for cervical cell self-collection testing?

Cervical cancer screening for women should begin at age 25, according to the American Cancer Society (ACS). An HPV primary test — one without a pap smear or cytology — should be performed every five years for women aged 25 to 65. A co-test — an HPV and pap smear performed together — also is an acceptable form of screening. A pap smear alone is recommended every three years for that age range. These guidelines are for women without any abnormal test results.

HPV self-collection also meets the guidelines, with ACS’ leader Dr. Karen E. Knudsen lauding its benefits: “Almost all cervical cancers are caused by persistent infection with certain types of HPV,” she says in a statement after FDA’s approval of the self-collection kit. “Self-collection can expand access to screening and reduces barriers, which will give more people the opportunity to detect, treat and ultimately survive cancer.”

According to Dr. Gwacham, there are no age limits on self-collection, and he says: “all patients should be eligible [for self-collection] when we start doing primary HPV screening, and that’s typically women in their 20s.”

But he also cautions against overly aggressive testing. “There’s no reason a 16-year-old or 17-year-old should be having a pap smear or an HPV test because, one, the great majority of these young women are not sexually active and, two, we don't want to be forced to intervene unnecessarily. The great majority of the time, they're going to clear that virus by themselves. It's typically not going to end up becoming a cancer.”

What do HPV test results mean?

A negative HPV test result means that none of the high-risk types of HPV are present. Patients should continue to follow the regular screening recommendations for future tests.

If the results of an HPV test are positive, it means that a strain of HPV that has been linked to cervical cancer has been identified and follow-up care is necessary.

A positive HPV test does not mean a woman has or will get cervical cancer, only that a type of the virus associated with elevated cancer risk has been detected.

When to contact a doctor

If the HPV test result is positive, it is necessary to follow up with a doctor who can advise on next steps.

The doctor may recommend another HPV test or pap smear or a procedure called a colposcopy in which a special device called a colposcope is used to examine the cervix more closely to see if abnormalities are visible.

A biopsy may be performed in conjunction with the colposcopy to collect a sample of cervical cells to examine under the microscope.

If the cells are extremely abnormal or precancerous, the doctor may recommend a procedure to remove the cells and the tissue around them. One such technique is called a loop electrosurgical excision procedure or LEEP. A thin wire loop, heated with electricity, is used to excise the abnormal tissue.

“If there's an abnormal test, then there's further investigative methods that we use to identify whether a patient has evidence of preinvasive or invasive cancer,” says Dr. Gwacham. “That typically involves colposcopy, biopsies, sometimes a LEEP or a cold knife conization [a surgical procedure to remove a cone-shaped portion of the cervix]. Then, based on what those results are, that determines your testing interval thereafter, whether it's in a year, in six months and so forth.”

Do HPV tests replace other cervical cancer screenings?

While experts hope more accessible HPV testing will help reduce the incidence of cervical cancer, it does not replace other cervical cancer screenings.

Receiving the HPV vaccine at a young age — starting as young as age 9 in both boys and girls — is also an important preventative measure. In certain instances, a doctor may recommend vaccination up to age 45.

Regular in-person checkups are also crucial to prevention.

“A visit to the doctor comes with a lot of things that a swab at home doesn't have, like the ability to have questions answered, the ability to obtain proper education about the vaccine or HPV or anything for that matter,” says Dr. Gwacham. “So, while I think self-collection is fantastic, I think that, if anything, it's going to be an adjunct, but it won't replace a visit to the doctor.”

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