Can HPV Self-Tests Truly Replace Pap Smears?

Back in May of this year, the FDA approved a new method of human papillomavirus (HPV) testing in a healthcare setting. Rather than a standard Pap smear performed with a speculum — a test dreaded by many patients — the new test allows for patients to swab their own vagina using a long cotton swab.

The Roche Cobas HPV assay and the Becton Dickinson Onclarity HPV assay are set to launch this fall with expanded indications for use that “allow for the patient to self-collect a vaginal swab in a healthcare setting when the patient and the healthcare provider determine that it is not possible for the clinician to collect a cervical specimen,” according to an FDA announcement.

While these HPV self-collection tests have several upsides, ob/gyns told MedPage Today that they don’t completely replace the utility of the Pap test — and the U.S. is still behind other countries when it comes to self-collection tests.

Pamela Berens, MD, an ob/gyn at the McGovern Medical School at UTHealth Houston, told MedPage Today that providers gather more information than just the Pap smear when performing the test. They’re conducting a pelvic exam, looking at the cervix for irregularities like polyps, and observing any unusual discharge that could indicate a yeast infection or bacterial vaginosis.

Plus, they’re actually conducting dual testing: the Pap itself and HPV testing, which have two separate results. At the same time, the ob/gyn might add on testing for sexually transmitted infections (STIs) like gonorrhea or chlamydia, though Berens said that many STIs could instead be detected via urine testing.

Berens noted that while some aspects of Pap and HPV testing have remained the same — using a speculum to access the cervix, taking a sample of cells, and having it tested in a lab to look for precancerous cells — the Pap test itself has already evolved over the years.

“Over time, we switched from using a flat slide — where you’d actually put the cells from the cervix on the slide — to doing it in a solution … and the solution made Pap smears much better,” Berens said. Then in the 90s, HPV testing became routine and the samples were analyzed for HPV type 16, 18, and 45, which are most associated with cervical cancer.

Shae Connor, MD, a gynecologic oncologist at UT Erlanger Women’s Oncology in Chattanooga, Tennessee, told MedPage Today that as a whole, standalone HPV testing is equivalent to cytology plus HPV testing.

“That’s hard for many physicians to swallow because we got so reliant on the Pap smear,” she said. “The Pap smear is actually a really bad test.”

Connor explained that with cytology alone, the test’s “sensitivity is terrible and the specificity is even worse … so when you look at HPV standalone testing, it’s actually just as good as Pap plus HPV.” Indeed, research from earlier this year found that HPV testing outperformed Pap smear in detecting cervical cancer precursor lesions.

Berens and Connor both noted that the HPV self-collected swab test would be more influential if it was also approved for at-home use.

“In Canada and Europe, at-home, self-collection tests have been used for years with really excellent results,” Connor said. “There’s plenty of data in those countries that wide implementation of self-collection kits at home increases screening rates, which overall decreases rates of cervical cancer.” Last year, a U.S.-based trial found that mailing patients HPV self-sampling kits boosted cervical cancer screening.

Connor said she suspects that part of why the U.S. has been so slow to adopt the HPV self-test is mistrust in the patient’s ability to self-collect, though she also noted that data indicate that self-collection is equally efficacious. The swab only needs to reach the vaginal wall — which is easier to reach than the cervix — in order to pick up the HPV virus.

“The whole approving it for in-office use is a little bit counterproductive, because we’re not going to reach more people if they already have to come into the office to do the initial test — we’re not going to reach any more people than the folks who are going to come in for a Pap smear,” Connor noted.

Berens also pointed out that most other countries where the test is used have a universal healthcare system. In that context, if there’s a positive result, a patient can simply go see a doctor without worrying about cost or access. But in the U.S., patients may be left unable to seek care if they get a positive or inconclusive result. Still, Berens said this new in-office option will be good for patients with phobias of pelvic exams, adding that’s where there will immediately be uptake.

Connor added that feeling emotionally, physically, or psychologically uncomfortable with a test is “the primary reason that women avoid the gynecologist — other than lack of health insurance or financial reasons — because it can be a traumatizing experience, especially for anyone who has a history of sexual trauma or abuse.”

Even within this group, if the HPV test comes back positive, Berens said patients may still end up needing a physical pelvic exam.

“It kind of got you out of the first exam, but now I’m going to need to do the exam,” she said, noting that a colposcopy would likely be the next step.