A study of more than 850 women demonstrated it is effective to conduct a human papillomavirus test in the same preservative fluid as a Pap test. This has the potential to increase efficiency and decrease waste. The findings were published online Oct. 13, 2017 in the Journal of Clinical Pathology.
As a result of the findings, organizations such as Kaiser Permanente can consider transitioning to single collection of a Pap test and HPV test, rather than sending two different samples to the lab, said lead author, Devansu Tewari, MD, MBA, a gynecologic oncologist at Kaiser Permanente in Orange County, California.
HPV infections are the most common sexually transmitted infections in the United States and are the main cause of cervical cancer in women. 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.
“The opportunity to move toward primary HPV screening would not have existed with the method we currently use,” Dr. Tewari said. “As future studies build upon this one, that potential of primary HPV screening is within reach. It is one of many ways we are working to enhance cervical cancer screening.”
This research fills an unmet need for the medical community, said Michael Kanter, MD, executive vice president and chief quality officer for The Permanente Federation, the national umbrella organization for the more than 21,000 physicians who provide care to Kaiser Permanente’s more than 11.8 million members.
“This research shows we are always innovating and finding ways to improve care delivery for our members, which highlights our commitment to shaping the future of health care,” Dr. Kanter said.
Last year, research at Kaiser Permanente in Southern California led to 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.
Identifying women at highest risk
In addition to allowing for a single collection, other findings in this study showed that the test gives clinicians the opportunity to identify whether the HPV virus type is one of the most carcinogenic. The HPV genotypes 16 and 18 cause approximately 70 percent of cervical cancers worldwide.
“This test not only allows health care providers to identify more women at highest risk for developing cervical cancer and to intervene earlier, but knowing the specific HPV type empowers providers to be more effective and accurate in their education and counseling of patients. This could lead to greater patient understanding as well as improved compliance with surveillance and treatment,” said Christina Hong, MD, a study co-author and assistant chief of service of the Obstetrics and Gynecology Department at Kaiser Permanente Orange County.
The study also found that there was a reliable performance of the test in a highly HPV-vaccinated population.
“The next step will include pilot studies to further expand on the recent study, while continuing to enhance our high-quality cervical cancer screening program,” Dr. Tewari said.
“This is an example of how the power of our integrated delivery model of care can meet national needs in health care while optimizing the health of our own patients,” Dr. Tewari said. “Kaiser Permanente’s diverse member base and electronic health records were key to this work, which has the power to transform practices and health care organizations approach to screening.”
Co-authors in the study were: Susan Novak-Weekley, PhD, Southern California Permanente Medical Group Regional Reference Laboratories, North Hollywood; and Shagufta Aslam, PhD, and Catherine M. Behrens, MD, PhD, of Roche Molecular Systems, Pleasanton, California.