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A Kaiser Permanente study found that a new way to test for HPV has the potential to increase efficiency and decrease waste.
Healthcare organizations can consider transitioning to single collection of a Pap test and HPV test, rather than sending two different samples to the lab, according to a study published in the Journal of Clinical Pathology.
HPV infections are the most common sexually transmitted infections in the United States. Based on data from 2009 to 2013, about 39,800 HPV-associated cancers occur in the United States each year: about 23,300 among women, and about 16,500 among men, according to the CDC. Cervical cancer is the most common HPV-associated cancer among women, and oropharyngeal cancers (cancers of the back of the throat, including the base of the tongue and tonsils) are the most common among men.
Last year, research at Kaiser Permanente in Southern California led to the FDA approval of the first HPV test that can be used with cervical cells obtained for a Pap test and collected in a specific preservative fluid. The study published online was the basis of that FDA approval.
Before FDA approval in 2016, a different HPV test had to be collected into an FDA-approved medium, leading to the need for two collection samples: one for HPV and one for Pap. Like a Pap test, an HPV test is done on a sample of cells collected from the cervix.
Both the Pap and HPV test are used to screen for cervical cancer. This research is a step toward making testing for HPV infections more simple and straightforward.
In the study of more than 850 women, author Devansu Tewari, MD, MBA, a gynecologic oncologist at Kaiser Permanente in Orange County, California, and colleagues, demonstrated that it is effective to conduct a human papillomavirus test in the same preservative fluid as a Pap test.
In the study, the women with an abnormal Pap smear had a Pap smear and separate HPV test as per normal screening within Kaiser’s program, but also had their preservative fluid media tested with the HPV test. The results were compared to the traditional separate sample and the women were examined to ensure that the results were comparable. Among 856 women, HPV prevalence was 45.8%; HPV 16 and HPV 18 prevalences were lower than expected in the 21- to 29-year-old group in this highly vaccinated population.
“As a result of these findings, healthcare providers can consider transitioning to single collection of a Pap test and HPV test, rather than sending two different samples to the lab, which has the potential to increase efficiency and decrease waste,” says Tewari. “In the era of HPV vaccination, our study was the first to show that HPV testing is still reliable in a highly pre-vaccinated population. For those organizations with dual collection techniques, transition to single collection and potentially improved cost structures is now available with an FDA approval.”
“In addition, for those organizations that are currently using Surepath preservative fluid, transition to the HPV test can allow the specific high-risk HPV type that is associated with precancerous and cancerous changes in the cervix to be identified,” he says. “This is important because clinical pathways of care and follow up of women with abnormal HPV tests can reduce biopsies and follow ups based upon knowing what virus type is involved.”
In the future, as managed care executives start examining their cervical cancer screening program, decisions around quality and improved cost structures can be factored more appropriately by potentially integrating this into their program, according to Tewari.
“This was not possible before if healthcare organizations were using Surepath [preservative fluid] and a separate medium for testing that did not allow for being able to determine the actual HPV type,” he says.
“Most importantly, managed care executives should realize the value of integrated delivery models of care being able to meet national unmet needs by conducting important clinical work that cannot be conducted within single academic and non-academic institutions,” Tewari says. “This study was able to be completed within one network given the integration of our managed care organization from the electronic record system and established clinical pathways. Clinical pathways are more likely to be integrated by managed care executives and provide opportunities that benefit all parties involved. This partnership with private industry enhanced both party’s opportunities including meeting an FDA need given their prior concerns.”
If this transition takes place, then follow up guidelines for women with this test should integrate national recommendations based upon HPV genotype (virus type) in conjunction with pap smear findings, according to Tewari.
“While this transition is ongoing, managed care executives should also start considering the value of primary HPV screening that the FDA has approved for the [cobas HPV test] and what this may mean in the future for cervical cancer screening programs,” he says. The [cobas HPV test] is the only FDA approved test to be used as primary screening instead of pap smear testing to determine appropriate follow up. Many countries worldwide are beginning this transition and although few groups have been moving toward that direction within the U.S., consideration for executives need to look at the quality and benefits to women and their own organizations if such an approach were taken.”