Sexually Transmitted Diseases
New Self-swab HPV Test Is An Alternative To Pap Smears. Here's How It Works.
A new option for cervical cancer screening gives patients a less-invasive alternative to conventional tests.
These new "self-collection tests" are scheduled to arrive in doctor's offices nationwide this month. The Food and Drug Administration (FDA) approved self-collection as a method to detect human papillomavirus (HPV), the leading cause of cervical cancer, in May. Screening tests are intended to flag people at high risk of cancer or precancer, not to diagnose the disease.
This FDA approval enables patients to collect their own clinical samples for cervical cancer screening. With the rollout of these tests, the U.S. Joins Australia, Canada, the Netherlands, Denmark and Sweden, where self-swabbing for HPV is already widely used.
For now, the samples, collected from the vaginal canal, must still be gathered in health care settings, such as doctor's offices. Other countries have allowed at-home self-sampling for HPV, but the method is still pending FDA approval in the U.S.
Here's what you should know about the newly available self-collection tests.
How is HPV related to cervical cancer?HPV is a common sexually transmitted infection that's primarily transferred through sexual intercourse or skin-to-skin contact. Most sexually active people will contract at least one type of HPV in their lifetime, but the infection normally resolves on its own.
Though more than 30 types of HPV can infect the genitals, only a small number — referred to as "high-risk" HPV — are associated with cancer. Low-risk HPV tends to have no symptoms and clears on its own, although sometimes, genital warts may appear. Nonetheless, this low-risk type of infection rarely leads to cancer.
Almost all cervical cancer cases are caused by long-term infections with high-risk HPV. A high-risk HPV infection that doesn't go away can lead to abnormal cell growth, which can then turn cancerous down the line.
The HPV vaccine can protect against most cases of cervical cancer. A 2024 study in the Journal of the National Cancer Institute found zero incidence of invasive cervical cancer among young Scottish women who'd received at least one dose of HPV vaccine. Moreover, women who'd received three doses of the vaccine — the number generally recommended — were significantly less likely to develop cervical cancer than unvaccinated women.
In the event someone develops high-risk HPV, there is no cure, but abnormal cervical cells can be removed before they cause cancer.
What do cervical cancer screening tests look for?There are two standard ways to check for cervical cancer: an HPV test and a Pap test.
An HPV test can detect the genetic material of high-risk strains of HPV that, if left untreated, can cause cancer. A Pap test, also called a Pap smear or cervical cytology, checks for changes in cervical cells that could lead to cancer. These changes include the cell's nucleus, which holds its DNA, growing abnormally large, Dr. Nicholas Wentzensen, a senior investigator at the National Cancer Institute's Division of Cancer Epidemiology and Genetics, told Live Science.
An HPV test can also be performed alongside Pap tests in what's called a co-test. The combined test can detect high-risk HPV and cervical cell changes using the same sample. The recommendations for who should get which test and how frequently varies with age and other health factors (see later section for details).
It is important to note that these are not diagnostic tests. Instead, their intent is to flag individuals at high risk of developing cancer or precancer. A positive result on any of these tests would require further testing — often a colposcopy-directed biopsy — to receive a diagnosis. .
Both conventional HPV tests and Pap tests have traditionally required a sample of cells collected from the cervix, the narrow canal that connects the uterus and vagina. During a pelvic exam performed by a doctor. The sample, taken during a pelvic exam*, is taken by a doctor who inserts a speculum into the vagina to widen it and then scrapes the cervix with a brush or spatula.
But now, the FDA has approved a far less invasive option: patients can now self-sample in a health care setting and use cells from the vagina, rather than the cervix. Studies have shown that samples from the vagina are just as effective for detecting HPV as those taken from the cervix and that no significant difference exists between self-collected and doctor-collected samples for HPV detection.
*Note that cervical cancer screenings and pelvic exams are not the same thing, although they're often performed at the same time. Pelvic exams are used to check on the health of female reproductive organs.
Why is cervical cancer screening important?Cervical cancer screening has been found to greatly reduce death rates from cervical cancer. For example, in England, regular screening is estimated to reduce cancer mortality by 70%, according to a 2016 study published in Nature. The idea is that, with routine screening and follow-up tests, cancer can be detected and treated early before it progresses to a more advanced, treatment-resistant stage of the disease.
The National Cancer Institute estimates that about 11,500 new cases of cervical cancer are diagnosed in the U.S. Every year. About half of these cases end up being diagnosed in patients who were not adequately screened, per current guidelines, or who had not undergone any screening at all.
Ideally, the tests prevent cancer deaths by detecting precancerous changes in cells early, when treatment is most beneficial. However, they can also pick up full-blown cancer in the event it's already developed. In either case, a positive screening test would then lead to formal diagnostic testing.
A speculum (pictured) is a device used to widen the walls of the vagina in order to expose the cervix. The new self-collection option doesn't require samples from the cervix, so it's less invasive. (Image credit: BSIP / Contributor via Getty Images) How do the new self-collection tests work?If opting to use the new self-collection tests, a patient should receive instructions on how to do so from their medical provider. The patient will complete the test in the clinic, but no medical supervision is required during the self-collection itself. In other words, a doctor doesn't need to be in the room when the sample is collected.
Generally, the patient is instructed to insert a long cotton swab into the vagina and then gently swirl it for 20 to 30 seconds to collect an adequate sample. The sample is then left at the health care provider's office, and from there, it is sent to a lab for analysis.
What are the advantages of self-collection compared with a Pap smear?The new self-collection option has the potential to increase the number of people who get cervical cancer screenings across the U.S. The hope is that these tests, which are more convenient and less invasive than the traditional screening approaches, will help reach patients who may forgo Pap tests for various reasons.
For many patients, screenings that involve a speculum can mean physical and emotional discomfort, said Dr. Ilana Cass, a gynecologic oncologist at Dartmouth Hitchcock Medical Center and a professor of Obstetrics and Gynecology at Dartmouth College in New Hampshire. A Pap smear can be triggering particularly for patients with a history of sexual violence, older patients with more sensitive vaginal tissues, and people with gender dysphoria.
"If we are able to invite more people in for testing through these expanded technologies, who would have previously been uncomfortable or would have been uninterested, this is really great. This is progress," Cass told Live Science.
Most cases of cervical cancer are caused by "high-risk" HPV viruses (pictured). (Image credit: BSIP / Contributor via Getty Images) Are there any downsides to the self-collection tests?A meta-analysis of studies, published in Nature, found that self-collected vaginal samples are comparable to cervical samples collected by a doctor, in terms of their ability to reveal HPV. One study included in the analysis found that tests that used self-collected samples were about 89% accurate at detecting HPV. By comparison, doctor-collected samples garnered nearly 88% accuracy.
Nonetheless, patients may have concerns about self-collection, Cass noted. These are often legitimate worries about performing the test correctly and getting a good enough specimen. Although self-collection will always be somewhat susceptible to user error, the method is highly sensitive — even if a patient collects only a small number of cells, the tests can adequately detect HPV.
Who should be screened for cervical cancer and how often?The American Cancer Society (ACS) recommends that regular cervical cancer screenings begin at age 25. These guidelines are the most up-to-date, as the recommendations from the U.S. Preventive Services Task Force — another expert group — are currently being revised, Wentzensen told Live Science.
According to the ACS guidelines:
It is important to note, however, that primary HPV tests are the gold-standard screening method to prevent cervical cancer. They are better than Pap smears at finding precancerous changes in cervical cells.
More frequent screening schedules than the one described above may be recommended for patients with a personal or family history of cervical cancer, or for those who have HIV or a compromised immune system. The important takeaway is to get screened regularly and follow through with recommended follow-up tests, to catch abnormalities early when treatment has the greatest chance of success.
This article is for informational purposes only and is not meant to offer medical advice.
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What You Need To Know About The New Self-Collection HPV Tests
Key TakeawaysA new HPV test for cervical cancer screening allows people to collect their own sample without needing a gynecologist to insert a speculum.
In May, the Food and Drug Administration (FDA) approved two HPV self-collection tests developed by the biotechnology company Roche and medical technology firm BD. These tests are now available in healthcare settings such as hospitals, pharmacies, health clinics, urgent care centers, and mobile testing clinics across the country.
With self-collection tests, people can use a vaginal swab to gather a sample, similar to urine tests at a clinic. They then give the sample to a healthcare provider, who sends it for lab analysis and later explains the results.
Human papillomavirus (HPV) is a group of 200 sexually transmitted viruses. HPV infections sometimes cause warts around the mouth, genitals, or anus that often go away without treatment. Some HPV strains, however, can be cancer-causing.
In the last few decades, scientists have found that nearly every case of cervical cancer is caused by an HPV infection. Detecting high-risk strains early on allows providers to treat the infection and prevent the cancer from developing.
Nearly half of people who develop cervical cancer in the United States were not up to date on their screening.
The FDA said self-collection tests should be used when a pelvic exam isn't possible. This may be due to a lack of access to a healthcare provider, personal or religious reasons for avoiding pelvic exams, or discomfort related to sexual trauma.
"There's a growing realization that usual care doesn't work for a whole bunch of people, and we need to get more creative and have alternative strategies," said Jane Montealegre, PhD, associate professor of cancer prevention and population sciences at MD Anderson Cancer Center. "The big promise of self-collection is that we can expand not just how screening is done, but when and where it's done."
Montealegre, who has studied HPV testing for a decade, said that when self-collection tests are offered, uptake among underscreened people increases twofold globally. In the U.S., people may lack insurance, live in rural areas with few healthcare providers, or have a schedule that makes it difficult to visit a health provider.
"We don't want to detract people going to see their OB-GYN if that's been working for them all along. But for many people, it hasn't," Montealegre said. "This is about empowering people who haven't traditionally participated in screening to have another option that might be for them and that they are in control of."
How Do HPV Self-Collection Tests Work? HPV tests are not the same as Pap smears. To give a pap test, an OB-GYN uses a speculum and stirrups to access the patient's cervix, where they collect cells using a long swab. The sample is sent to a lab where a pathologist smears the cells onto a slide and analyzes them under a microscope to check for irregular cells that could indicate cancer. Traditional HPV tests use the same collection process, but the sample is run through a machine rather than reviewed by a human. The HPV self-collection tests allow patients to swab themselves without needing a pelvic exam. Depending on the test, your provider might have you use a long swab or a brush with an injectable applicator to take a sample of the vaginal wall. Carolyn Kay, MD, a medical affairs lead at Roche, said the HPV test is "much more objective" and efficient than a Pap test. It allows providers to identify the presence of a high-risk infection rather than wait for a human to identify abnormal cells once there's a burgeoning problem. "Discovering the link [between HPV and cervical cancer] decades ago was instrumental because before then, they were just looking at the cells and didn't really understand why the cells were becoming abnormal," Kay said. What Can the Self-Collection Tests Detect? There are more than 100 different genotypes of HPV, but only a small portion of which are potentially cancer-causing, according to Jeff Andrews, MD, vice president of medical affairs and diagnostic solutions at BD Life Sciences. About 80% of sexually active people get HPV by the age of 45, but the infection usually clears on its own without causing serious symptoms. People who test positive for two strains—HPV 16 and 18—are at the highest risk of developing cervical or other cancers if the infection isn't treated. Both available self-collection tests report the results as positive or negative for HPV 16, 18, or any of the other 12 viral strains of concern. The BD test uses "extensive genotyping," which means it reports the exact strain detected. Follow-up action will depend on which strain or strains your test detected. Your provider may run more tests with the same vaginal sample, ask you to come back for a more intensive exam, or monitor to see if the infection progresses. The new HPV tests are only FDA-approved to screen for cervical cancer, but Andrews said they could prove useful for broader cancer prevention. In addition to cervical cancer, the virus can cause anal, oropharyngeal, penile, vaginal, and vulvar cancers. About 70% of oropharyngeal cancers are caused by HPV, and there are currently no screening guidelines for the disease. Andrews said research is underway to learn whether new HPV tests could help prevent head, neck, and other cancers. When Should You Opt for Self-Collection? The accuracy of provider-collected tests and self-collected tests are "identical," Montealegre said. Just because you collect the sample yourself doesn't make it an inferior test. "Some people feel really embarrassed or discomforted or ashamed to undress in front of a healthcare provider and have a pelvic exam. There's a lot of trauma in our population that makes getting a pelvic exam really painful and unpleasant. And for many, there are cultural or religious objections to having this exam," Montealegre said. However, Montealegre said that if you're already in the habit of seeing your OB-GYN or having an annual well-woman exam, it's best to continue with traditional HPV and Pap tests. For one, the self-collection tests only require the user to scrape the vaginal wall. When your provider conducts an HPV test, they will swab the cervix. That way, if your test is abnormal, they've already collected the cells they need to run a Pap test to see if the virus has affected the cervix. Besides, HPV testing is just one part of a well-woman or OB-GYN visit. Your provider may also look for abnormalities in your vagina, check for lumps in your breast, order tests for sexually transmitted infections, ask questions about your sexual health, and more. How Can You Get a Self-Collection HPV Test? If traditional HPV and Pap testing is uncomfortable for you, you can ask for a self-collection option at your annual physical or well-woman visit. The tests will be available in many locations, including pharmacies, urgent care centers, hospitals, and federally qualified health centers, which serve about a third of people living in poverty. Under the Affordable Care Act, cervical cancer screening is covered without an additional copay. Self-collection tests should be covered the same as those collected by a provider. The CDC also provides funding to states to offer free cervical and breast cancer screening to people who lack insurance. In the next few weeks, the American Society for Colposcopy and Cervical Pathology is expected to release new testing guidelines that incorporate new self-collection tests. Currently, primary HPV testing is not recommended for people younger than 25 because most HPV infections in young adults clear on their own and never lead to cancer. The current U.S. Preventive Services Task Force recommendations for cervical cancer screening are: Ages 21 to 29: Have a Pap test every 3 years Ages 30 to 65 have these options: A Pap test alone every 3 years A high-risk HPV test alone every 5 years A high-risk HPV test with a Pap test (co-testing) every 5 years. "It's always a good idea to go see your healthcare provider annually," Kay said. "They can make the right recommendation of how frequently you should get screened." What This Means For You People with a cervix who are older than 21 years old should periodically get screened for cervical cancer using an HPV test or Pap test. You can speak to a health provider or refer to the USPTSF guidelines for more information about the testing recommended for your age group.Cervical Cancer Prevention: A Guide To HPV Vaccines, Cost And Eligibility
Dr Sonia Golani provides essential insights into everything you need to know about HPV vaccines for cervical cancer prevention.
Cervical cancer is one of the most preventable types of cancer, yet it remains a significant health risk for women worldwide. At the forefront of prevention are HPV vaccines, which offer powerful protection against the human papillomavirus – the leading cause of cervical cancer. But who can get the vaccine, how much does it cost, and where is it available? In this guide, Dr Sonia Golani, Consultant Gynaecologist and Obstetrician at Bhailal Amin General Hospital in Vadodara breaks down everything you need to know about the HPV vaccines."Cervical cancer is a leading cause of cancer-related deaths among women in India, and vaccinating young girls and women against it can significantly reduce their risk of developing the disease," says our expert.
The HPV vaccine is most effective when administered before exposure to the virus, typically through sexual contact. Therefore, the recommended age for vaccination is between 9 and 14 years, with two doses given six months apart. Vaccinating girls at this age ensures they are protected before they become sexually active, providing maximum efficacy.If not vaccinated during adolescence, women can still receive the vaccine up to the age of 26 years with good results. In this age group, the vaccine helps protect against HPV strains that they may not have been exposed to yet.
For women between the ages of 26 and 45, the vaccine is also available, though the efficacy is slightly lower due to potential prior exposure to the virus. Despite this, vaccination is still recommended for those who have not been previously vaccinated, as it can offer protection against multiple strains of HPV. For individuals aged 14 to 45 years, three doses of the vaccine are required, typically administered at 0, 2, and 6-month intervals.
Several brands of HPV vaccines are available in India, including Gardasil 9, a nonavalent vaccine priced at approximately Rs 10,000 per dose, Gardasil 4 (quadrivalent) at around Rs 4,000 per dose, and Cervavac, an indigenous quadrivalent vaccine by the Serum Institute of India, priced at about Rs 2,000 per dose. All of these vaccines are safe, with no major side effects reported so far.HPV vaccination plays a crucial role in preventing cervical cancer, making it essential for parents and healthcare providers to ensure adolescent girls are vaccinated early. For older women, especially those up to age 45, the vaccine remains a valuable preventive measure. With more affordable and accessible vaccines like Cervavac, India is taking significant strides in the fight against cervical cancer, and keeping yourself informed is the only way to make informed decisions about safeguarding your health.
Also Read: Cervical Cancer Awareness: Your Guide To Early Detection And Prevention
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