Simple, affordable HPV test delivers results in less than an hour

A team of researchers led by Rice University, in collaboration with colleagues in Mozambique and The University of Texas MD Anderson Cancer Center, has developed a simple, affordable human papillomavirus (HPV) test that delivers results in less than an hour with no specialized laboratory required. The breakthrough could provide an option for women in low-resource settings to be screened and treated for cervical cancer in a single clinic visit, a step that global health experts say could save countless lives. The research was recently published in Nature Communications.

Cervical cancer is considered easily preventable, yet it remains one of the deadliest cancers for women worldwide. According to the World Health Organization (WHO), each year more than 350,000 women die from the disease, and nearly 90% of those deaths occur in low- and middle-income countries where access to regular cervical cancer screening is limited. Persistent infection with high-risk types of HPV causes nearly all cases of cervical cancer. While vaccines are helping reduce HPV infections globally, most women at risk today are adults who did not get the vaccine in childhood. For them, regular and reliable screening is the only path to early detection and lifesaving treatment.

Cervical cancer is almost entirely preventable, yet it still claims hundreds of thousands of lives each year. Our goal was to build a test accurate enough to guide treatment, fast enough to use during a clinic visit and inexpensive enough to scale. This assay meets all three goals.”

Maria Barra, first author, bioengineering graduate student at Rice

The WHO recommends HPV DNA testing as the gold standard for cervical cancer screening, but existing HPV DNA tests often require expensive lab equipment and trained laboratory technicians – barriers that make widespread use in low-resource settings unattainable. As a result, many women are not screened for cervical cancer. Even where screening programs exist, results may take days or weeks to return. Patients leave to await results. However, where care facilities are remote, few in number and difficult to access, patients are often unable to return for treatment, leaving precancerous lesions to progress unchecked. A faster test without reliance on a lab could provide results and prompt treatment during the same patient visit.

“This is the kind of pragmatic innovation we focus on when engineering for global health – fewer steps, lower cost, higher impact,” said Rebecca Richards-Kortum, the Malcolm Gillis University Professor of Bioengineering and co-director of the Rice360 Institute for Global Health Technologies at Rice. “Our data show you can bring lab-grade molecular screening to almost any setting without sacrificing reliability. Providing accurate results quickly enables clinicians to start treatment without delay.”

The new test uses a method called loop-mediated isothermal amplification (LAMP), which simplifies DNA detection by running at a single temperature. Instead of requiring DNA extraction – a complicated step in many existing tests – this process is extraction-free. A swab sample is chemically lysed, added directly to the LAMP reagents and incubated for about 45 minutes in a portable heater then read by fluorescence.

The test detects three of the most dangerous HPV types (HPV16, HPV18 and HPV45), which together cause about 75% of all cervical cancers. It also includes a built-in cellular control to ensure that the sample was collected properly.

In clinical studies, the test showed 100% agreement with the reference standard in 38 samples from Houston and 93% agreement in 191 samples from Maputo, Mozambique. The cost of the test is projected to be less than $8 each, and the portable device it runs on is battery-operated, making it ideal for clinics without consistent electricity.

“High mortality rates from cancer are closely associated with delays in diagnoses and limited access to early treatment,” said Cesaltina Lorenzoni, head of the National Cancer Control Program at the Mozambican Ministry of Health, director of science and teaching at Maputo Central Hospital and professor of pathology at the Eduardo Mondlane University Faculty of Medicine. “Point-of-care technologies that can aid clinicians in identifying cancer and guide treatment options in a single patient visit could be lifesaving in clinical settings in Maputo. This assay performed very well in our clinical setting and holds promise of delivering the kind of rapid, specific, cost-effective cancer detection that would meaningfully improve outcomes for women in our country.”

The WHO has set ambitious targets to screen 70% of women worldwide by 2030 as part of its public health campaign to eliminate cervical cancer. Meeting that goal will require screening millions of women in various global settings that lack advanced lab equipment or resources.

By cutting out expensive instruments, minimizing sample handling and delivering rapid, accurate results, the LAMP assay represents a significant step toward realistically achieving the WHO goal. Critically, it opens the door to “screen-and-treat” strategies, where if a positive result is found, the patient can be treated on the same medical visit, reducing treatment delays and loss to follow-ups.

The team is currently working to expand the test to cover additional high-risk HPV types and is also working on lyophilized (freeze-dried) reagents that don’t require refrigeration, further increasing the test’s usability in rural or resource-limited areas. The team also plans to conduct usability studies with frontline health workers to refine the design before larger clinical rollouts.

“Our goal is a complete, field-ready kit that community clinics can use anywhere,” Richards-Kortum said. “If we can help health systems move to same-day screen-and-treat, we can move towards a future where cervical cancer can be eliminated globally.”

This study was conducted by a multidisciplinary team in the U.S. and Mozambique with IRB approvals from MD Anderson, Harris Health, Rice and Mozambique’s National Bioethics Committee. All participants provided informed consent. The research was also supported by the National Institutes of Health.